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CONTACT: Sharon Hartson Stine
Mobile: 609.458.5604
shartson@phila.acr.org
Cisplatin Prior to Chemoradiation is Less Effective than Standard Treatment for Anal Canal Cancer
Philadelphia - April 23, 2008 - When administered before chemoradiation, the common anti-cancer drug cisplatin neither improved disease-free survival nor reduced the number of colostomies needed when compared to the standard treatment for patients with anal canal cancer, according to a study conducted by the Radiation Therapy Oncology Group (RTOG) and published in the April 23 issue of the Journal of the American Medical Association (JAMA). RTOG is a clinical research component of the American College of Radiology (ACR).
The seven-year, multicenter trial, funded by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and coordinated by the RTOG was the largest cooperative group phase III clinical trial of its kind for patients with cancer of the anal canal. The study was led by RTOG investigator Jaffer Ajani, M.D., professor in the Department of Gastrointestinal Medical Oncology at The University of Texas M. D. Anderson Cancer Center, and it compared the standard treatment regimen of fluorouracil plus mitomycin and radiotherapy to fluorouracil plus cisplatin and radiotherapy in 644 patients with anal canal cancer. The five-year disease-free survival rate was 60 percent in the mitomycin-based group and 54 percent in the cisplatin-based group. The five-year overall survival rate was 75 percent in patients receiving mitomycin versus 70 percent receiving cisplatin, with more cancer-related deaths in the cisplatin-based group (54 patients) compared to mitomycin-based group (28 patients).
Patients who received cisplatin-based treatment resulted in significantly higher rates of colostomy (19 percent versus 10 percent). It is widely held among practicing oncologists that the colostomy procedure, which creates an alternative exit from the colon to divert waste, should only be used as a last resort in the treatment of anal canal cancer due to its considerable affect on the patient's quality of life.
"Based on preliminary data from smaller trials that suggested considerable sensitivity to the fluorouracil plus cisplatin combination, cisplatin has gained popularity among oncologists as a drug to treat anal canal cancer," said Ajani. "However, it is clear from this data that cisplatin is not the drug to use and its use should be discontinued in standard therapy."
The study expanded on findings from two pilot studies that encouraged oncologists to believe that cisplatin could potentially be used to reduce the cancer in the primary tumor and lymph nodes prior to administration of concurrent chemoradiation. The research group hypothesized that using cisplatin to downsize the tumors first could be an effective strategy for treating the disease because previous studies have established that chemoradiation is more effective for smaller anal canal carcinomas than larger ones.
"There have been incremental advancements in the treatment for anal canal cancer in the last decade and there was hope that the unique cisplatin-based strategy would offer an improved, less-toxic therapy to patients suffering from the disease," Ajani said. "While our research did not uncover a new standard of treatment, comparative studies such as this one are imperative to determining best practices and informing community oncologists."
According to the American Cancer Society, an estimated 5,070 new cases of anal canal cancer will be diagnosed in 2008. The five-year disease-free survival of approximately 65 percent has not improved since the early 1990s. Primary anal canal tumor size has a direct bearing on cure rates, and the five-year survival rates decrease significantly for tumors larger than 5 cm diameter. Approximately 25 percent of newly diagnosed anal carcinomas are larger than 5 cm in diameter.
From this study, it is anticipated that researchers will look to explore other options such as newer targeted therapies and intensity-modulated radiation plus concurrent chemotherapy to improve disease-free and colostomy-free survival relative to the continued standard of concurrent chemoradiation with fluorouracil and mitomycin.
In addition to the RTOG participants, investigators from four other NCI-funded cooperative groups, the Cancer and Leukemia Group B, the Eastern Cooperative Oncology Group, the North Central Cancer Treatment Group, and the Southwest Oncology Group, also enrolled patients on the study.
(JAMA. 2008;299[16]:1914-1921.)
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Press Release
Contact: Sharon Hartson Stine
Mobile: 609.458.5604
E-mail: shartson@phila.acr.org
Addition of Gemcitabine to Standard Therapy After Surgery Improves Survival for Pancreatic Cancer Patients
Philadelphia - March 4, 2008 - Adding the drug gemcitabine to standard chemoradiotherapy following surgery improved survival for patients with the most common form of pancreatic cancer, according to a new study conducted by the Radiation Therapy Oncology Groups (RTOG), a clinical research component of the American College of Radiology (ACR). RTOG investigators found that the new therapy was associated with a demonstrated survival benefit. However, since this improvement was not statistically significant the researchers concluded that new, more effective systemic therapies still are needed to prevent recurrence of this often-deadly disease.
The four-year, multicenter trial, funded by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), was the largest clinical study of its kind and the first phase III clinical trial in the United States in three decades to look at additional (adjuvant) treatment for pancreatic surgery patients. Results of the study, RTOG 9704, which focused on patients with pancreatic head adenocarcinoma, or cancer of the head (the wider part) of the pancreas, are published in the March 5 issue of the Journal of the American Medical Association (JAMA).
"This study will change standard practice across the country for postoperative treatment of this type of pancreatic cancer," says the principal investigator, William F. Regine, M.D., professor and chairman of radiation oncology at the University of Maryland School of Medicine and chief of radiation oncology at the University of Maryland Marlene and Stewart Greenebaum Cancer Center. "Although the results are not considered statistically significant, they are clinically meaningful. There was consistent improvement in survival among patients with cancers of the head of the pancreas who received gemcitabine, at least up to three years following diagnosis," Dr. Regine says.
Cancer of the pancreas is the fourth leading cause of cancer death in the United States, with 32,000 people dying of the disease each year. Only 4 percent of people are still alive five years after they are diagnosed. Surgery is the treatment of choice, but less than 15 percent of patients are eligible because the disease is usually diagnosed at an advanced stage.
"RTOG has reported the study's preliminary results at major cancer society meetings and many oncologists are already using this new combination therapy with gemcitabine to treat patients post surgery," relates Walter J. Curran, Jr., M.D., the RTOG Group Chair, and the Lawrence W. Davis Professor and Chair of the Department of Radiation Oncology in the Emory School of Medicine and Chief Medical Officer of the Emory Winship Cancer Institute.
Gemcitabine interferes with the growth of cancer cells and belongs to a group of medicines called antimetabolites. It is also used to treat patients with advanced pancreatic cancer who are not eligible for surgery, as well as a number of other cancers. The randomized controlled phase III trial included 451 eligible and analyzable patients enrolled between July 1998 and July 2002 at 164 U.S. and Canadian institutions, with follow-up through August 2006
Thirty-one percent of the participants with pancreatic head adenocarcinoma were still alive three years after diagnosis following surgery and treatment with gemcitabine, another chemotherapy drug called 5-fluorouracil (5-FU) and radiation. That compares with a 22 percent three-year survival rate for patients who were treated with 5-FU and radiation alone after surgery - the standard postoperative treatment for this type of cancer since the 1980s.
The median survival for patients who received gemcitabine was 20.5 months, compared to 16.9 months for patients who received the standard treatment. Median survival is the point at which half of the patients in each group are still living. Researchers did not see any benefit of adding gemcitabine for patients with cancer in other parts of the pancreas.
Dr. Regine says that the treatment was well-tolerated, and patients in the study had the lowest rate of cancer recurring in its original location than in any previous study. The tumor came back in the same area in 23 percent of the patients, compared to 40 percent to 60 percent of patients in other studies. But, according to Dr. Regine, 70 percent of the patients in this study experienced spread of their cancer to other parts of the body, a process that is known as metastasis.
"Clearly, metastatic disease is a huge problem, and we need more clinical research to identify new systemic or targeted therapies to prevent this type of recurrence," Dr. Regine says. RTOG researchers already are planning to test new agents, using the new combination therapy of gemcitabine, 5-FU and radiation as the standard. They also will study the genetic profiles of these cancers to help determine how well patients will respond to a particular therapy, which would allow doctors to tailor the treatment to the individual patient.
In addition to the RTOG, two other NCI-funded cooperative groups, the Eastern Cooperative Oncology Group and the Southwest Oncology Group, were also involved in the study.
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Press Release
Contact: Sharon Hartson Stine
Mobile: 609.458.5604
E-mail: shartson@phila.acr.org
RTOG Cancer Research Highlighted in 26 Presentations at ASTRO
Philadelphia - October 26, 2007 - Radiation Therapy Oncology Groups (RTOG) investigators will report recent results from the group's research during 26 presentations at the 49th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in Los Angeles, CA, October 28 - November 1, 2007. RTOG, an NCI-funded national clinical trials group, is a clinical research enterprise component of the American College of Radiology (ACR).
"As evidenced by our 26 presentations at ASTRO this year, RTOG continues in its role as the leading group conducting clinical cancer research involving radiation therapy." said Walter J. Curran, Jr., M.D., RTOG Group Chair and Clinical Director of the Kimmel Cancer Center at Thomas Jefferson University. "For almost 40 years RTOG investigators have set the standards for radiation oncology research. RTOG's multicenter trials of advanced technologies involving multiple treatment modalities, coupled with our translational and quality-of-life research, are defining cancer care in many important disease sites."
The 26 oral and poster presentations highlight the group's research in bladder, breast, central nervous system, esophageal, gynecologic, head & neck, lung, pancreatic, and prostate cancers. Attached is a complete list the RTOG presentations at ASTRO.
RTOG Presentations at ASTRO 2007
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Late Pelvic Toxicity Following Bladder-Sparing Therapy in Patients With Invasive Bladder Cancer: Analysis of RTOG 8903, 9506, 9706, 9906.
Shipley, W., Bae, K., Efstathiou, J., Kaufman, D., Hagan, M. and Sandler, H. |
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Neurocognitive Impact of Whole Brain Radiation on Patients with Brain Metastases: Secondary Analysis of RTOG BR-0018.
Kwok, Y., Won, M., Regine, W., Mehta, M., Schmitt, F., Patchell, R. and Bruner, D. |
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Variability of Target and Normal Structure Delineation for Breast-Cancer Radiotherapy: A RTOG Multi-Institutional and Multi-Observer Study
Li, Arthur, X. A., D. W., Buchholz, T. A., MacDonald, S., Marks, L. B., Pierce, L. J., Taghian, A. G., Vicini, F. A., Woodward, W. A., White, J. A. |
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A Phase II Study of a Paclitaxel Based Chemoradiation Regimen with Selective Surgical Salvage for Resectable Locoregionally Advanced Esophageal Cancer: Initial Reporting of RTOG 0246.
Swisher, S., Winter, K., Komaki, R., Ajani, J., Wu, T.-T., Hofstetter, W., Konski, A. and Willett, C. |
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Extended Field Irradiation and Intracavitary Brachytherapy Combined with Cisplatin Chemotherapy for Cervical Cancer with Positive Para-aortic or High Common Iliac Lymph Nodes: Results of Arm 2 of RTOG 0116.
Small Jr, W., Winter, K., Levenback, C., Iyer, R., Hymes, S., Jhingran, A., Gaffney, D., Erickson, B. and Greven, K. |
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The Influence of Accrual Volume and National Cancer Institute-Comprehensive Cancer Center (NCI-CCC) Designation on Outcome for the RTOG 9111 Intergroup Trial for Laryngeal Preservation.
Weber, R., Harris, J., Rosenthal, D., Goepfert, H., Forastiere, A., Ang, K. and Cooper, J. |
Associations Between Radiation Doses to Pharyngeal Regions and Severe Late Toxicity in Head and Neck Cancer Patients Treated with Concurrent Chemoradiotherapy An RTOG Analysis.
O'Meara, E., Machtay, M., Moughan, J., McIlvaine, J., Galvin, J., Forastiere, A., Trotti, A., Garden, A., Cooper, J. and Ang, K. |
A Phase III Trial to Compare Standard Vs Accelerated Fractionation in Combination With Concurrent Cisplatin for Head and Neck Carcinomas (RTOG 0129): Report of Compliance and Toxicity.
Ang, K., Pajak, T., Rosenthal, D., Nguyen, F., Lu, C., Kim, H., Axelrod, R., List, M., Silverman, C., Weber, R. and Wheeler, R. |
Phase II Multi-institutional Study of IMRT ± Chemotherapy for Nasopharyngeal Carcinoma (RTOG 0225): Preliminary Results.
Lee, N., Harris, J., Garden, A., Straube, W., Bosch, W., Morrison, W., Quivey, J., Thorstadt, W., Jones, C. and Ang, K. |
Phase II Randomized Trial of Surgery Followed by Chemoradiation Plus Cetuximab for High-Risk Squamous Cell Carcinoma of the Head and Neck (RTOG 0234).
Harari, P., Harris, J., Kies, M., Myers, J., Foote, R., Machtay, M., Rotman, M., Khuntia, D., Straube, W. and Ang, K. |
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"Less is Not Always More"; An Economic Analysis of Radiation Therapy Oncology Group 9410.
Konski, A., Bhargavan, M., Owen, J., Komaki, R., Langer, C., Byardt, R., Paulus, R., Choy, H., Bruner, D. and Curran Jr, W. |
Quality of Life (QOL) Supercedes the Classic Predictors of Survival in Locally Advanced Non-Small Cell Lung Cancer (NSCLC): An Analysis of Radiation Therapy Oncology Group (RTOG) 9801.
Nicolaou, N., Moughan, J., Sarna, L., Langer, C., Werner-Wasik, M., Komaki, R., Machtay, M., Wasserman, T., Bruner, D. and Movsas, B. |
Toxicity Analysis of RTOG 0236 Using Stereotactic Body Radiation Therapy to Treat Medically Inoperable Early Stage Lung Cancer Patients.
Timmerman, R., Paulus, R., Galvin, J., Michalski, J., Straube, W., Bradley, J., Fakiris, A. J., Bezjak, A., Videtic, G. and Choy, H. |
Dosimetric Evaluation of Heterogeneity Corrections for RTOG 0236: Hypofractionated Radiotherapy of Inoperable Stage I/II Non-Small Cell Lung Cancer.
Xiao, Y., Straube, W., Bosch, W., Timmerman, R. and Galvin, J. |
RTOG 0324: A Phase II Study of Cetuximab (C225) in Combination with Chemoradiation (CRT) in Patients (PTS) with Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC): Correlation between EGFR Expression and the Patients' Outcome.
Komaki, R., Moughan, J., Ang, K., Curran Jr, W., Robert, F., Thariat, J., Zhang, H. Z., Werner-Wasik, M., Doescher, P., Choy, H. and Blumenschein, G. |
Concomitant Radio-Chemotherapy (RT-CT) Versus Sequential RT-CT in Locally Advanced Non-Small Cell Lung Cancer (NSCLC): A Meta-Analysis Using Individual Patient Data (IPD) from Randomized Clinical Trials (RCTS).
Rolland, E., Le Pechoux, C., Curran Jr, W., Furuse, K., Fournel, P., Uitterhoeve, L., Clamon, G., Ulutin, H., Stewart, L., Auperin, A. and Group), N. C. |
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Post-Resectional CA 19-9 Values > 90 are Associated with Significantly Worse Survival in Patients with Pancreatic Carcinoma Treated with Adjuvant Therapy on RTOG 9704 - Implications for Current and Future Trials.
Regine, W., Garcia, M., Berger, A., Abrams, R., Safran, H., Konski, A., Benson III, A., Macdonald, J., Rich, T. and Willett, C. |
A Phase II Study of Bevacizumab with Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer: RTOG PA0411.
Crane, C. H., Winter, K., Regine, W., Safran, H., Rich, T., Curran Jr, W., Wolff, R. A. and Willett, C. |
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The Influence of Age as a Predictor of Outcome in Prostate Cancer Patients Treated on RTOG Trials.
Parikh, P., Bae, K., Hanks, G., Shipley, W., Pilepich, M. and Sandler, H. |
Cardiovascular Mortality Following Androgen Deprivation Therapy in Men with Locally Advanced Prostate Cancer: An Analysis of RTOG 8531.
Efstathiou, J., Bae, K., Shipley, W., Hanks, G., Pilepich, M., Sandler, H. and Smith, M. |
Impact of Adjuvant Hormonal Therapy Duration and Timing of Salvage Hormonal Therapy in Prostate Cancer Patients with Unfavorable Prognosis Treated by Radiotherapy. A Secondary Analysis of RTOG 8531.
Souhami, L., Bae, K., Pilepich, M. and Sandler, H. |
Surrogate Endpoints for Prostate Cancer Survival: A Secondary Analysis of RTOG 9202.
Ray, M., Bae, K., Hussain, M., Hanks, G., Shipley, W. and Sandler, H. |
Does Neoadjuvant Hormonal Therapy Improve Progression-Free Survival in Prostate Cancer Patients Receiving Dose-Escalated 3D Conformal Radiation Therapy on RTOG 9406?
Valicenti, R., Bae, K., Michalski, J., Cox, J., Shipley, W. and Sandler, H. |
Fit of a Generalized Lyman Normal-Tissue Complication Probability (NTCP) Model to Grade > 2 Late Rectal Toxicity Data From Patients Treated on Protocol RTOG 9406
Tucker, S. L., Dong, L., Bosch, W. R., Michalski, J., Winter, K., Lee, A. K., Cheung, M. R., Kuban, D. A., Cox, J. D., Mohan, R. |
RTOG 0215 Treatment of Erectile Dysfunction (ED) in Patients Treated with Neoadjuvant and Concurrent Androgen Deprivation (AD) and Radiotherapy (RT) For Prostate Cancer (PC).
Bruner, D., James, J., Pisansky, T., Rotman, M., Corbett, T., Speight, J., Byhardt, R., Sandler, H. and Berk, L. |
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A Survey of the ITC Volumetric Treatment Planning Data Archive Supporting RTOG Advanced Technology Clinical Trials
Bosch, W. R., Straube, W. L., Matthews, J. W., Michalski, J. M., Deasy, J. O., Young, B., O'Meara, E., Curran, W. J., Cox, J. D., Purdy, J. A. |
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Press Release
Contact: Thomas Wudarski
Office: 215-574-3205
E-mail: twudarski@phila.acr.org
RTOG Presents Record Number of Presentations at ASTRO
Philadelphia, PA - November 1, 2006 - Radiation Therapy Oncology Groups (RTOG) investigators will report recent results from the group's research during 37 presentations at the 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in Philadelphia, PA, November 5 - 9, 2006. RTOG, an NCI-funded national clinical trials group, is a clinical research enterprise component of the American College of Radiology (ACR).
"Our record number of 37 presentations at ASTRO this year reinforces RTOG's role as the leading group conducting clinical cancer research involving radiation therapy," said Walter J. Curran, Jr., M.D., RTOG Group Chair and Clinical Director of the Kimmel Cancer Center at Thomas Jefferson University. "Once again RTOG sets the standard for radiation oncology research. RTOG investigations of advanced technologies in a multi-modality setting coupled with our translational and quality-of-life research are defining cancer care in several disease sites."
The 37 oral and poster presentations highlight the group's 39 years of research in central nervous system, cervical, head & neck, lung, and prostate cancers. Attached is a complete list the RTOG presentations at ASTRO.
RTOG Presentations at ASTRO 2006
Brain Tumors
An Update of Phase II Results from RTOG 0211: A Phase I/II Study of Gefitinib with Radiotherapy in Newly-Diagnosed Glioblastoma Multiforme
Chakravarti, A., Berkey, B., Robbins, I., Guha, A., Curran Jr, W., Brachman, D., Schultz, C., Mehta, M.
Validation of EORTC Prognostic Factors for Adults with Low Grade Glioma: A Report Utilizing Intergroup 86-72-51
Brown, P., Daniels, T., Ballman, K., Felton, S., Buckner, J., Arusell, R., Curran Jr, W., Abrams, R., Earle, J. and Shaw, E.
Age as an Independent Prognostic Factor in Patients with Glioblastoma: A Radiation Therapy Oncology Group Analysis
Siker, M., Berkey, B., Nelsen, D., Curran Jr, W., Michalski, J., Souhami, L., Chakravarti, A., Yung, W.A., DelRowe, J., Coughlin, C. and Mehta, M.
Breast Cancer
A Phase II Trial of Brachytherapy Alone Following Lumpectomy for Select Breast Cancer: Tumor Control and Survival Outcomes of RTOG 9517
Arthur, D., Winter, K., Kuske, R.R., Bolton, J.S., Rabinovitch, R., White, J., Hanson, W., Wilenzick, R.M. and McCormack, B.
Cervical Cancer
Celebrex (celecoxib) and Chemoradiation in Patients with Locally Advanced Cervical Cancer. An Efficacy Report of RTOG 0128
Gaffney, D., Winter, K., Dicker, A., Miller, B., Eifel, P., Ryu, J., Avizonis, V.N., Fromm, M. and Greven, K.
Gastrointestinal Cancers
RTOG 9704 - Radiotherapy Quality Assurance (QA) Review and Survival
Abrams, R., Winter, K., Regine, W., Safran, H., Hoffman, J., Konski, A., Benson III, A., MacDonald, J., Rich, T. and Willett, C.
Intergroup RTOG 9811 Phase III Comparison of Chemoradiation with 5-FU and Mitomycin vs 5-FU and Cisplatin for Anal Canal Carcinoma: Impact on Disease-Free, Overall and Colostomy-Free Survival
Gunderson, L., Winter, K., Ajani, J., Pedersen, J., Benson, A., Thomas Jr., C., Mayer, R., Haddock, M., Willet, C. and Rich, T.
Recursive Partitioning Analysis (RPA) of Prognostic Factors in Six Radiation Therapy Oncology Group (RTOG) Trials of Chemoradiotherapy for Unresectable Pancreatic Cancer
Garofalo, M., Winter, K., Regine, W., Rich, T., Komaki, R., Tepper, J., Gunderson, L. and Willett, C.
A Randomized Phase II Study of Two Paclitaxel-Based Chemoradiotherapy Regimens for Patients with Non-operative Esophageal Carcinoma (RTOG 0113)
Komaki, R., Winter, K., Ajani, J., Kelsen, D., Minsky, B., Liao, Z., Bradley, J., Fromm, M., Hornback, D. and Willett, C.
Three-Year Results of RTOG-0012 Randomized Phase II Study of Neoadjuvant Combined Modality Chemoradiation for Distal Rectal Cancer
Mohiuddin, M., Garcia, M., Mitchell, E., Hanna, N., Yuen, A., Nichols, C., Share, R., Hayostek, C. and Willet, C.
Patterns of Locoregional Recurrence in Gastric Cancer Patients Treated with Preoperative Chemoradiation
Reed, V., Krishnan, S., Bhosale, P., Janjan, N., Das, P., Delclos, M., Lowy, A., Mansfield, P., Ajani, J. and Crane, C.
A Phase III Intergroup Trial (RTOG 9704) of Adjuvant Pre- and Post Chemoradiation (CRT) 5-FU vs. Gemcitabine (G) for Resected Pancreatic Adenocarcinoma
Regine, W., Winter, K., Abrams, R., Safran, H., Hoffman, J., Konski, A., Benson III, A., MacDonald, J., Willet, C. and Rich, T.
A Randomized Phase II Trial Comparing Two Paclitaxel (P)-Cisplatin (C) Containing Chemoradiation (CRT) Regimens As Adjuvant Therapy in Resected Gastric Cancer (RTOG 0114)
Schwartz, G., Winter, K., Minsky, B., Janjan, N., Schaefer, P., Thomson, J., Anne, P.R., Gross, H., Willet, C. and Kelsen, D.
Head and Neck Cancer
Long-Term Survival Results of a Phase III Intergroup Trial (RTOG 9501) of Surgery Followed by Radiotherapy vs. Radiochemotherapy for Resectable High Risk Squamous Cell Carcinoma of the Head and Neck
Cooper, J., Pajak, T., Forastiere, A., Jacobs, J., Campbell, B., Saxman, S., Kish, J., Cmelak, A., Kim, H. and Fu, K.
Phase II Multi-Institutional Study of IMRT for Oropharyngeal Cancer (RTOG 0022): Early Results
Eisbruch, A., Harris, J., Chao, C., Garden, A., Straube, W., Schultz, C., Sanguineti, G., Jones, C., Bosch, W. and Ang, K.K.
Results of RTOG 9703 - A Randomized Phase II Trial of Concurrent Radiation and Chemotherapy for Advanced Squamous Cell Carcinomas of the Head and Neck: Long-term Results and Late Toxicities
Garden, A.S., Harris, J., Vokes, E., Forastiere, A., Ridge, J., Jones, C., Horwitz, E., Glisson, B., Nabell, L. and Cooper, J.
A Randomized Trial of Hyperfractionation versus Standard Fractionation in T2 Squamous Cell Carcinoma of the Vocal Cord
Trotti, A., Pajak, T., Emami, B., Hammond, E., Jones, C., Morrison, W., Sagar, S., Ridge, J., Fu, K. and Ang, K.K.
Lung Cancer
Comparison of 5-Year Survival Between RTOG-9410 and a Phase II Study of Induction Chemotherapy Followed by Efaproxiral + Radiotherapy in Patients with Locally Advanced NSCLC
Choy, H., Swann S., Nabid, A., Stea, B., Roa, W., Souhami, L., Yunus, F., Hackman, J., Beard, S., and Curran Jr, W.:
A Statistical Model of the Risk of Radiation Pneumonitis Based on Combined RTOG and Washington University Data
Deasy, J. O., El Naqa, I., Hope, A. H., Lindsay, P. E., Sause, W. T., Graham, M. L., Bosch, W. R., Matthews, J. W., Bradley, J. D.
Sociodemographic Factors are Significant Predictors of Toxicity in RTOG Non-Operative NSCLC Trials
Movsas, B., Swann, S., Curran Jr, W., Coyne, J., Konski, A., Komaki, R., Bradley, J., Langer, C., Choy, H. and Watkins Bruner, D.
Prostate Cancer
Predictors of Late Toxicities and Symptom Clusters in Radiation Therapy Oncology Group (RTOG) Prostate Cancer Trials of High Risk Patients: A Meta-analysis of Physician Rated Toxicities
Watkins-Bruner, D., Moughan, J., Roach III, M., Movsas, B., Konski, A., Hanks, G., Cox, J. and Swann, S.
Pretreatment Tumor Biomarker Stability in Archival Tissue from Men Treated with Radiotherapy for Prostate Cancer: An Analysis of RTOG 9202 and Fox Chase Randomized Trials
Hachem, P., Bae, K., Khor, L.-Y., Hammond, E., Al-Saleem, T., Li, L., Hanks, G., Sandler, H., Pollack, A.
Ten Year Follow-up of RTOG 9202; A Phase III Trial of the Duration of Elective Androgen Deprivation in Locally Advanced Prostate Cancer
Hanks, G., Bae, K., Porter, A., Grignon, D., Brereton, H., Venkatesan, V., Horwitz, E., Lawton, C., Sandler, H. and Shipley, W.
Cox-2 Overexpression Predicts Prostate Cancer Outcome: An Analysis of RTOG 9202
Khor, L.-Y., Bae, K., Hammond, E., Pollack, A., Venkatesan, V., Rosenthal, S., Sandler, H., Hanks, G., Shipley, W. and Dicker, A.
Biochemical Recurrence and Late Toxicity following External Beam Radiotherapy combined with Permanent Source Prostate Brachytherapy: Analysis of RTOG 0019
Lee, W., Bae, K., Lawton, C., Gillin, M., Morton, G., Firat, S., Baikadi, M., Greven, K., Kuettel, M. and Sandler, H.
Comparison of Two Types of Biochemical Failures within the ASTRO and Phoenix Consensus Definitions in Patients Treated on RTOG 9202 and 9413
Pan, C., Bae, K., Hanks, G., Shipley, W., Roach III, M. and Sandler, H.
Temporal Profile of Serum Testosterone with Goserelin Use and Cessation: Analysis of RTOG Protocol 9202
Pisansky, T.M., Bae, K., Hanks, G.E., Shipley, W.U., Sandler, H.M.
Bcl-2 and Bax Predict Prostate Cancer Outcome In Men Treated With Androgen Deprivation And Radiotherapy on RTOG 9202
Pollack, A., Moughan, J., Khor, L.-Y., Al-Saleem, T., Hammond, E., Venkatesan, V., Rosenthal, S., Hanks, G., Shipley, W. and Sandler, H.
Socio-demographic Predictors of Biochemical Failure and Survival Among High Risk Patients Treated on Radiation Therapy Oncology Group (RTOG) Prostate Cancer Trials: A Meta-analysis
Roach III, M., Moughan, J., Movsas, B., Konski, A., Hanks, G., Cox, J. and Watkins-Bruner, D.
Does Testosterone Influence Radiation-induced Toxicity in Radiotherapy of the Prostate? A Secondary Analysis of RTOG Protocol 9413
Taussky, D., Bae, K., Bahary, J.-P., Roach III, M., Lawton, C., Shipley, W. and Sandler, H.
The Prognostic Value of Survivin in Locally Advanced Prostate Cancer: A Study Based on RTOG 8610
Zhang, M., Ho, A., Hammond, E., Sause, W., Pilepich, M., Shipley, W., Sandler, H., Khor, L.-Y., Pollack, A. and Chakravarti, A.
Quality of Life
Pretreatment Quality of Life in a Prospective Lung Cancer Trial: Should Gender Differences be Stratified by Performance Status?
Kohl, R., Swann, S., Bruner, D., Kaiser, L., Sause, W., Choy, H. and Movsas, B.
The Addition of Chemotherapy to Radiation is Cost-Effective in the Treatment of Patients with Locally Advanced Laryngeal Cancer: An Economic Analysis of Radiation Therapy Oncology Group (RTOG) 9111
Konski, A., Bhargavan, M., Owen, J., Paulus, R., Cooper, J., Forastiere, A., Geopfert, H., Ang, K.K. and Bruner, D.
Is There a "Disconnect" Between Physician and Patient-Reported Outcomes (PROs) ? An Analysis of RTOG 9801
Sarna, L., Swann, S., Langer, C., Werner-Wasik, M., Nicolaou, N., Komaki, R., Machtay, M., Smith, C., Axelrod, R. and Movsas, B.
Miscellaneous
A Review of the Activities of the ITC in Support of RTOG Advanced Technology Clinical Trials
Purdy, J., Bosch, W., Straube, W., Matthews, J., Haynes, R., Michalski, J., Martin, E., Winter, K., Curran Jr, W. and Cox, J.
RTOG Participating Physician and Research Associates Attitudes Regarding Clinical Trials: Implications for Improving Recruitment
Walker, E., James, J., Harston, S., Gore, E., Prestidge, B., Michalski, J., Chamberlain, R.M., Gwede, C. and Bruner, D.
Adaptive Protocol Development and Trial Initiation: RTOG's Experience in the Current Clinical Trials Environment
Young, B.K., Martin, E., Hoffman, W., Wudarski, T., King, S., Brasteter, H., Galvin, J. and Curran Jr, W.
RTOG Research in the Spotlight for 13 ASCO Presentations
Philadelphia June 1, 2006 - Radiation Therapy Oncology Group (RTOG) investigators will report recent results from the group's research during 13 presentations at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta Georgia, June 2 - 5, 2006. RTOG, an NCI-funded national clinical trials group, is a clinical research enterprise component of the American College of Radiology (ACR).
"Our ASCO presentations spotlight RTOG's role as the leading cooperative group conducting clinical cancer research involving radiation therapy," said Walter J. Curran, Jr., M.D., RTOG Group Chair and Clinical Director of the Kimmel Cancer Center at Thomas Jefferson University. "Our multi-modality approach coupled with our biomarker and quality-of-life research continues to define cancer care in several disease sites."
The 13 oral and poster presentations, and 2 additional abstracts published in the proceedings, add to the group's 35 years of research in central nervous system, anal canal, head & neck, lung, pancreatic, and prostate cancers. Below is a complete list of the RTOG presentations at ASCO.
RTOG ASCO Presentations
Anal Cancer
Jaffer Ajani, MD, University of Texas MD Anderson Cancer Center
Intergroup RTOG 98-11: A phase III randomized study of 5-fluorouracil (5-FU), mitomycin, and radiotherapy versus 5-fluorouracil, cisplatin and radiotherapy in carcinoma of the anal canal. (Abstract 4009)
Brain Tumors
Sherry Fox, PhD, University Virginia School of Nursing
Prospective neurocognitive effects and quality of life (QOL) in patients with multiple brain metastases receiving whole brain radiation (WBRT) ± thalidomide on RTOG trial 0118. (Abstract 8589)
Luana Maria Poeta, MD, Johns Hopkins University
Prognostic implication of p53 mutations in HNSCC: Results of Intragroup margin study (E4393). (Abstract 5504)
Arnab Chakravarti, MD, Massachusetts General Hospital
An update of phase II results from RTOG 0211: A phase I/II study of gefitinib with radiotherapy in newly-diagnosed glioblastoma multiforme. (Abstract 1527)
Frank S. Lieberman, MD, University of Pittsburgh
Phase II trial of concomitant low dose temozolomide with external beam radiation (EBRT) followed by 12 months of temozolomide and irinotecan for newly diagnosed glioblastoma (GBM): Preliminary results of RTOG 04-20. (Abstract 1510)
Michael Vogelbaum, MD, Cleveland Clinic Foundation
RTOG 0131: Phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligodendrogliomas - relationship between 1p/19q status and progression-free survival.
Edward Shaw, MD, Wake Forest University
Initial Report of Radiation Therapy Oncology Group 9802: Prospective studies in adult low-grade glioma (LGG). (Abstract 1500)
Head and Neck Cancer
Mitchell Machtay, MD, Thomas Jefferson University
Pre-treatment and treatment related risk factors for severe late toxicity after chemo-RT for head and neck cancer: An RTOG analysis. (Abstract 5500)
Andre Konski, MD, Fox Chase Cancer Center
Altered fractionated radiotherapy is cost-effective in the treatment of locally advanced head and neck cancer: an economic analysis of Radiation Therapy Oncology Group (RTOG) 90-03. (Abstract 6007)
Arlene Forastiere, MD, Johns Hopkins University
Long-term results of Intergroup RTOG 91-11: A phase III trial to preserve the larynx - Induction cisplatin/5-FU and radiation therapy versus concurrent cisplatin and radiation therapy versus radiation therapy. (Abstract 5517)
Lung Cancer
Corey Langer, MD, Fox Chase Cancer Center
Phase I study of Irinotecan (Ir) and Cisplatin (DDP) in combination with thoracic radiotherapy (RT), either twice daily (45 Gy) or once daily (70 Gy), in patients with limited (Ltd) small cell lung carcinoma (SCLC): Early analysis of RTOG 0241. (Abstract 7058)
Prostate Cancer
Jean-Paul Bahary, MD, Notre Dame Hospital
Does timing of androgen deprivation influence radiation-induced toxicity? A Secondary Analysis of Radiation Therapy Oncology Group (RTOG) Protocol 9413. (Abstract 4655)
Eric Bernstein, MD, Indiana University
Looking for new targets for prostate cancer therapy: nuclear factor kappa B and CXCR4 Co-expression in prostate specimens from RTOG-8610.
Deborah Watkins Bruner, PhD, University of Pennsylvania
Late toxicities and predictors of symptom clusters in RTOG prostate cancer trials of high risk patients: A meta-analysis.
Pancreatic Cancer
William Regine, MD, University of Maryland
RTOG 9704 a phase III study of adjuvant pre and post chemoradiation (CRT) 5-FU vs. gemcitabine (G) for resected pancreatic adenocarcinoma. (Abstract 4007)
The Radiation Therapy Oncology Group (RTOG) is a clinical research enterprise of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
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Press Release
Contact: Thomas Wudarski
Office: 215-574-3205
E-mail: twudarski@phila.acr.org
RTOG Begins Accrual to Major Study for High-Risk Prostate Cancer Patients
Philadelphia, PA - March 16, 2006 - The Radiation Therapy Oncology Group (RTOG) has begun accrual to a major study for high-risk prostate cancer patients that adds chemotherapy to the standard treatment of radiotherapy and hormone suppression. The trial is open to RTOG member facilities in the US and Canada and it is expected to accrue 600 prostate cancer patients who are at risk for failure from conventional therapy. RTOG is a clinical research enterprise component of the American College of Radiology (ACR).
"While most men with prostate cancer do quite well with standard treatment, such as radiation therapy combined with hormonal therapy, there are subsets of patients that may benefit from more aggressive therapy," said Howard Sandler, M.D., protocol chair and professor in the department of radiation oncology at the University of Michigan. "Our goal is to improve the long-term survival of men who have two or more factors that put them at high risk for failure with standard treatment and with this study we hope to identify the patients that will benefit the most from the addition of chemotherapy to their treatment schedule."
Prostate cancer is a common cause of cancer morbidity and mortality in the United States. In 2006, there will be an estimated 234,460 new cases of prostate cancer and 27,350 prostate cancer deaths in the United States.
The study, RTOG 0521: A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT VS AS and 3DCRT/IMRT followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer, builds upon past RTOG research that explored the role of hormone suppression for high-risk patients and defined subsets of patients who had a greater likelihood for failure with standard therapy. All patients entered on this study will receive eight weeks of hormone suppression therapy before and after standard radiation therapy to the prostate using either 3-dimensional conformal radiation therapy (3DCRT) or intensity-modulated radiation therapy (IMRT) techniques. After radiation therapy half of the men entered on the trial will also receive six three-week cycles of chemotherapy consisting of docetaxel and prednisone. The docetaxel is administered intravenously once every three weeks and the prednisone is taken orally every day during the three-week cycle.
The Radiation Therapy Oncology Group (RTOG) is a clinical research enterprise of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services
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Press Release
Contact: Thomas Wudarski
Office: 215-574-3205
E-mail: twudarski@phila.acr.org
International Collaborative Brain Tumor Study To Utilize Chemotherapy after Radiotherapy and Genetic Marker Analysis
Philadelphia, PA - March 15, 2006 - The Radiation Therapy Oncology Group (RTOG), in conjunction with the European Organization for Research and Treatment of Cancer (EORTC), have launched a landmark study to determine if the administration of high-dose temozolomide after radiotherapy leads to improved outcome for newly diagnosed glioblastoma patients.
Since correlative laboratory studies have shown a link between tumor MGMT gene expression and treatment response, this trial will also examine the relationship between methylated MGMT status and temozolomide dose on survival.
The study is the first international brain tumor trial coordinated by a research organization from the United States. More than 800 total patients will be entered from RTOG member facilities in the US and Canada, and from EORTC members across Europe. RTOG is a clinical research enterprise component of the American College of Radiology (ACR).
"The activation of this study represents a unique collaboration for cancer clinical trial research," said Jeffrey Abrams, Chief, Clinical Investigations Branch, Cancer Therapy Evaluation Program, National Cancer Institute. "The RTOG and the EORTC, together with the NCI, worked through many complicated issues concerning the study design, patient registration, data collection, and reporting to bring about this international trial. It is our hope that collaborations such as this will lead more rapidly to more effective cancer treatments and significant improvements in patient survival."
Glioblastoma is the most common malignant brain tumor with upwards of 10,000 newly diagnosed cases per year. The prognosis for glioblastoma patients is grim with most studies reporting a median survival of 10 to 12 months. Efforts to improve survival for these patients have revolved around the addition of chemotherapy pre- and post-radiotherapy. Newer approaches are attempting to identify the patients who will most benefit from a specific type, dose, or schedule of chemotherapy combined with radiotherapy.
"The RTOG views this trial as a major step toward a broad menu of international trials testing new and exciting therapies for brain tumor patients", said Walter J Curran, Jr, MD, RTOG Group Chairman and Clinical Director of the Kimmel Cancer Center of Jefferson in Philadelphia.
The RTOG-led study, RTOG 0525/EORTC 26052_22053: Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose-Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma, builds upon the work of Mark R. Gilbert, MD, the RTOG study chair from the University of Texas M.D. Anderson Cancer Center, and the work of Roger Stupp, MD, University of Lausanne in Switzerland, with the EORTC and the National Cancer Institute of Canada.
The trial will examine the benefit of dose-intensive temozolomide after radiotherapy through a multi-center, international prospective clinical trial. Newly diagnosed glioblastoma patients will be registered on this study after surgery but before the start of radiotherapy. Tumor tissue samples will be sent to a central pathology laboratory for histologic confirmation and MGMT status analysis.
Patients will take a daily dose of temozolomide orally during radiotherapy. At the completion of radiotherapy, patients will be randomly assigned to receive either the standard treatment schedule consisting of temozolomide once a day for five days every four weeks for up to one year, or the dose-intensive schedule, consisting of temozolomide once a day for 21 days every four weeks for up to one year.
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The Radiation Therapy Oncology Group (RTOG) is a clinical research enterprise of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
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Press Release
Contact: Thomas Wudarski
Office: 215-574-3205
E-mail: twudarski@phila.acr.org
Adam P. Dicker, MD, PhD, New RTOG Vice-Chair for Translational Research
Philadelphia, PA - January 17, 2006 - Adam P. Dicker, MD, PhD, has been appointed the Radiation Therapy Oncology Group (RTOG) Vice-Chair for Translational Research and chair of the RTOG translational research program (TRP) committee. Dr. Dicker is Associate Professor of Radiation Oncology and Director of the Division of Experimental Radiation Oncology in the Department of Radiation Oncology at Thomas Jefferson University in Philadelphia. RTOG is a clinical research enterprise component of the American College of Radiology (ACR).
"Dr. Dicker is an internationally respected researcher in the areas of the epidermal growth factor receptor (EGFR), nanoparticles, and brachytherapy for prostate cancer," said Walter J. Curran, Jr., M.D., RTOG Group Chair and Clinical Director of the Kimmel Cancer Center at Thomas Jefferson University. "He has been an instrumental member of the RTOG TRP committee and I know that under his leadership the committee will continue to enhance the RTOG's research efforts." Dr. Dicker replaces Paul Okunieff, MD, of the University of Rochester who served in this position since 1999.
According to Dr. Dicker, "The RTOG translational research program is charged with translating basic research findings into clinical research questions. Our goal is to bring the promising developments found in the laboratory into clinical research as quickly as possible. RTOG, with its network of members in the United States, Canada and internationally, is in a unique position to identify and test this research."
The RTOG TRP Committee sponsors research and educational programs that highlight emerging findings about tumor behavior, molecular mechanisms and the recent links between therapy and disease. TRP Committee members work with clinical scientists from both the academic and industrial communities to integrate new information into clinical trial designs. The TRP committee contributes directly to the research of the RTOG by conducting correlative studies, participating in the design of clinical studies, and evaluating protocol results to enhance and expand the hypotheses being tested.
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Radiation Therapy Oncology Group
1818 Market Street, Suite 1600 • Philadelphia, PA 19103 • www.rtog.org • www.acr.org
press release
RTOG Study Shows Significantly Improved Survival for Prostate Cancer Patients
Treated with Zoladex® (Goserelin) Adjuvant to Radiotherapy
Philadelphia, PA - April 1, 2005 – Prostate cancer patients live longer when given goserelin immediately following radiotherapy, according to a new long-term study by the Radiation Therapy Oncology Group (RTOG), a clinical research component of the American College of Radiology (ACR). The publication in the April issue of the International Journal of Radiation Oncology Biology Physics, details the ten-year results of a national multicenter clinical trial that enrolled nearly 1,000 patients with locally advanced prostate cancer. The RTOG study, one of the longest and largest studies of its type, concluded that administering goserelin following radiotherapy reduces the progression of prostate cancer and significantly improves survival.
“The RTOG results give increased hope to prostate cancer patients,” comments Colleen Lawton, M.D. of the Medical College of Wisconsin and a co-author of the publication. “Men diagnosed with prostate cancer can now expect to live longer and live a life free from a recurrence of their disease.”
The RTOG study showed that the chance of survival ten years after treatment was 10% higher for men who received goserelin immediately following their radiation therapy for locally advanced prostate cancer rather beginning hormonal therapy only upon tumor progression (49% vs. 39%). Likewise, local progression was reduced from 38% to 22% for men receiving adjuvant goserelin.
Prostate cancer is the most commonly diagnosed cancer in men in the United States with over 230,000 new cases expected this year and it is the second leading cause of death due to cancer. The RTOG study evaluated the effectiveness of administering goserelin to patients with prostate cancer treated with radiotherapy. Nearly one thousand (977) patients with locally advanced prostate cancer received either radiotherapy followed by monthly adjuvant goserelin 3.6 mg, or radiotherapy alone followed by observation and goserelin administration at relapse.
Goserelin
Goserelin, first introduced in 1987, is a Luteinising Hormone-Releasing Hormone agonist (LHRHa) which reduces levels of sex hormones (testosterone in men and oestradiol in women) and is used to treat prostate cancer in men and hormone-dependent breast cancer in pre- and peri-menopausal women.
Prostate cancer
Prostate cancer is the presence of cancer cells in the prostate gland. It is the most commonly diagnosed male cancer in the United States, and is second only to lung cancer as a cause of cancer death. The prostate is a male sex gland that produces a thick fluid that forms part of semen. It is normally about the size of a walnut and is located below the bladder and in front of the rectum. Over 230,000 men in the United States will be diagnosed with prostate cancer this year and of those, 30,000 are expected to die from their disease.
The manuscript, Androgen Suppression Adjuvant to Definitive Radiotherapy in Carcinoma of the Prostate – Long Term Results of Phase III RTOG 85-31, was published in the April 1, 2005 edition of the International Journal of Radiation Oncology Biology Physics, vol. 61, pages 1285-1290. The independent study was coordinated by the Radiation Therapy Oncology Group (RTOG), with participation from its member institutions. The National Cancer Institute provided financial support the study and AstraZeneca provided the study drug, Zoladex® for patients enrolled in the study.
Study authors include: Miljenko V. Pilepich, MD, from the University of California Los Angeles, Kathryn Winter, MS, from the American College of Radiology, Colleen A. Lawton, MD, from the Medical College of Wisconsin, Robert E. Krisch, from the University of Pennsylvania, Harvey B. Wolkov, MD, from Radiological Associates of Sacramento, Benjamin Movsas, MD, from Fox Chase Cancer Center, Eugen B. Hug, MD, from Dartmouth Hitchcock Medical Center, Sucha O. Asbell, MD, from Albert Einstein Medical Center in Philadelphia, and David Grignon, MD, from Wayne State University.
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The Radiation Therapy Oncology Group (RTOG) is a clinical research component of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
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Radiation Therapy Oncology Group
1818 Market Street, Suite 1600 • Philadelphia, PA 19103 • www.rtog.org • www.acr.org
press release
RTOG & SWOG Open Clinical Trial for Locally Advanced Lung Cancer
Testing the Value of Radiotherapy Given Concurrently with Pre-Operative Cisplatin & Docetaxel (Taxotere®)
Philadelphia, PA, April 2005 – The Radiation Therapy Oncology Group (RTOG), together with the Southwest Oncology Group (SWOG), has launched a phase III study to determine the optimal induction therapy for patients with operable locally advanced non-small cell lung cancer (NSCLC). The protocol, RTOG 0412/SWOG S0332, will test the effectiveness of preoperative chemotherapy versus preoperative concurrent chemotherapy and thoracic radiotherapy followed by surgical resection and consolidation chemotherapy in favorable prognosis patients with stage IIIA (N2) NSCLC.
According to the study principal investigator, Maria Werner-Wasik, M.D., of Thomas Jefferson University, “Defining the optimal induction therapy would represent an important improvement in the management of locally advanced NSCLC. We hope that the results of this study improve the chance for long-term survival for these patients and provide us further data about the nature of this disease.”
Although both RTOG and SWOG have a long history of conducting clinical trials for patients with locally advanced NSCLC, there is currently no consensus on the standard treatment for these patients. Clinical trials and retrospective case studies support the view that induction therapy followed by surgery and chemotherapy is the most effective option for controlling both local disease and distant metastases, but the question of whether to include radiotherapy with induction chemotherapy has yet to be answered.
Patients enrolled on this study will be randomized to receive induction therapy consisting of either chemotherapy alone or concurrent chemotherapy plus radiotherapy prior to surgical resection and consolidation chemotherapy. The induction chemotherapy in both arms will consist of cisplatin and docetaxel, and the consolidation chemotherapy for both arms will consist of three cycles of docetaxel beginning four to six weeks after surgery.
Several correlative studies will be performed to take advantage of the rich data expected from this trial. For example:
- Tumor biopsies and blood samples will be evaluated to investigate the association of DNA damage repair genes (ERCC1 and XRCC1), microtubule- related proteins (TUBB-III and MAP4), and shed tumor DNA with patient response and outcome.
- Proteomic analysis by MALDI-TOF will be performed on serial blood samples drawn pre- and post-treatment and on pre-treatment tumor samples to identify surrogate markers for response.
- Preliminary data indicate that positron emission tomography (PET) with the glucose analogue [18F] fluoro-2 deoxy-D-glucose (FDG) may be able to help predict long-term response to therapy for NSCLC patients. Therefore, both pre- and post-induction therapy FDG-PET scans will be performed and the role of FDG-PET in predicting long-term outcome as well as pathological response in both the tumor and the mediastinal lymph nodes will be evaluated.
- Since differences in reported adverse events are expected in the two treatment groups, a patient-reported functional status evaluation will be conducted to measure the quality of life issues of both induction therapies.
- Comorbidity factors will be assessed for their impact on treatment and prognosis.
The trial will enroll 574 non-small cell lung cancer patients who have a single, newly diagnosed stage IIIA (T1-T3) primary lung parenchymal lesion with ipsilateral involved mediastinal lymph nodes measuring < 3 cm and N2 nodes separate from the primary tumor. Over 300 RTOG and SWOG member institutions in North America will be eligible to participate in this trial.
Lung cancer is the second most commonly diagnosed cancer in the United States and the leading cause of cancer-related death. It is expected that 163,500 men and women will die from the disease in 2005.
For more information about RTOG 0412/SWOG S0332, or to locate a participating institution visit the National Cancer Institute’s (NCI) Web site, http://cancertrials.nci.nih.gov. Additional information is also available at the RTOG Web site at www.rtog.org and at the SWOG Web site at www.swog.org.
Taxotere® is a registered trademark of Aventis Pharmaceuticals, a member of the sanofi-aventis Group. For more information about Taxotere®, please visit www.aventisoncology.com.
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The Radiation Therapy Oncology Group (RTOG) is the clinical research component of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
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- RTOG Re-elects Walter J. Curran, Jr., MD, for Third Term as Group Chair
- Jeffrey Bradley, MD, Elected and Louis Souhami, MD, Re-elected to Executive Committee
- Committee Leadership Positions Filled
Philadelphia, PA, February 21, 2005 – Walter J. Curran, Jr., M.D., was re-elected for a third term as RTOG Group Chair at the January RTOG Semi-Annual Meeting. Dr. Curran, who is also the Clinical Director of the Kimmel Cancer Center at Thomas Jefferson University, was first elected as RTOG Group Chair in 1997. “I am honored that the RTOG leadership has placed their trust in me for a third term as Group Chair. Several challenges lie ahead for RTOG, including its competitive grant renewal in 2007 and the need to expand our roster of important clinical trials in this era of stable federal funding. I am confident that the RTOG will successfully meet these challenges and continue in its mission to improve the survival rates and quality of life of people with cancer,” states Dr. Curran.
RTOG also elected Jeffrey Bradley, M.D., of Washington University in St. Louis, as a Member-at-Large of the RTOG Executive Committee. Dr. Bradley replaces Ritsuko Komaki, M.D., of the University of Texas M.D. Anderson Cancer Center, who completed two three-year terms that began in 1999. Luis Souhami, M.D., of McGill University, was re-elected to a second three-year term.
David K. Gaffney, M.D., of the University of Utah, has been appointed Chair of the RTOG Gynecology Cancer Working Group. Dr. Gaffney replaces Kathryn Greven, M.D., of Wake Forest University, who served as the working group chair since 1995.
Howard Safran, M.D., of Rhode Island Hospital was named Medical Oncology Chair of the RTOG Gastrointestinal Cancer Committee. He replaces Jaffer Ajani, M.D., of the University of Texas M.D. Anderson Cancer Center, who served in that position since 1990.
Harvey Pass, M.D., of Wayne State University, was named the Thoracic Surgery Chair of the RTOG Lung Cancer Committee. Dr. Pass replaces David Johnstone, M.D. of the University of Rochester who served in that position since 1998.
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The Radiation Therapy Oncology Group (RTOG) is a clinical research component of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
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RTOG Once Again a Major Presenter at ASTRO Meeting
Philadelphia, PA, September 30, 2004 – RTOG investigators are once again scheduled to be major presenters at the Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO). Sixteen abstracts based on RTOG clinical trials, including a Plenary Session presentation, will be presented at the Atlanta, GA meeting October 3 – 7, 2004. RTOG, an NCI-funded national clinical trials group, is a grantee organization of the American College of Radiology (ACR).
“Sixteen presentations at ASTRO confirms RTOG’s role as the preeminent group conducting clinical cancer research involving radiation therapy,” said Walter J. Curran, Jr., M.D., RTOG Group Chair and Clinical Director of the Kimmel Cancer Center at Thomas Jefferson University. “Not only are we at the forefront of radiation oncology research, but our multi-modality approach is defining cancer care in several disease sites. ”
The Plenary Session will include the preliminary results of an RTOG clinical trial of definitive radiotherapy combined with erythropoietin for patients with squamous cell carcinoma of the head and neck presented by lead study author Mitchell Machtay, M.D. of Thomas Jefferson University in Philadelphia, Pennsylvania.
The sixteen RTOG oral and poster presentations revolve around the group’s three decades of research in CNS, cervix, endometrial, head & neck, metastatic, and prostate cancers. Attached is the complete list of RTOG presentations at ASTRO.
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The Radiation Therapy Oncology Group (RTOG) is a clinical research component of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
RTOG Presentations at ASTRO 2004
Brain Tumors
Radiation Therapy (RT) Alone vs Intensive Procarbazine-CCNU-Vincristine Chemotherapy Followed by RT for Anaplastic Oligodendroglioma (and Mixed Oligo-Astrocytoma): RTOG Intergroup Protocol 94-02 – Edward G. Shaw, M.D., Wake Forest University – October 4, Session G, 2:50 PM, #57.
Phase I/II Conformal Three-Dimensional Radiation Therapy Dose Escalation Study in Patients with Supratentorial Glioblastoma Multiforme: RTOG 98-03 – Maria Werner-Wasik, M.D., Thomas Jefferson University Hospital – October 4, Session G, 3:00 PM, #58.
Cervical Cancer
Feasibility of RNA Collection for Micro-Array Gene Expression Analysis in the Treatment of Cervical Carcinoma: A Scientific Correlate of RTOG C-0128 – David K. Gaffney, M.D., Ph.D., University of Utah – October 5, Poster Session, 4:30, #2239.
Prostate Cancer
Results of a Prospective Multi-Institutional Phase II Trial (RTOG 98-05) of Transrectal Ultrasound Guided Permanent Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma – Colleen Lawton, M.D., Medical College of Wisconsin – October 5, Session K, 1:35 PM, #90.
Clinical Outcome of Patients Treated with 3D Conformal Radiation Therapy for Prostate Cancer on RTOG 94-06 – Jeff Michalski, M.D., Washington University – October 4, Session H, 3:00 PM, #66.
Progression Free Survival after Whole-Pelvic vs "Mini-Pelvic" or Prostate Only Radiotherapy: A Subset Analysis of RTOG 9413, a Phase III Prospective Randomized Using Neoadjuvant and Concurrent Hormonal Therapy – Mack Roach, III, M.D., University of California-San Francisco – October 4, Poster Discussion 2, 10:15 AM, #1014.
Influence of Number of CAG Repeats on Local Control in the RTOG 86-10 Protocol – May Aabdel-Wahab, M.D., University of Miami – October 6, Poster Discussion 9, 1:15 PM, #1118.
MDM2 as a Predictor of Prostate Cancer Outcome: An Analysis of RTOG 8610 – Li Yan Khor, M.D., Fox Chase Cancer Center – October 5, Poster Session, 4:30 PM, #2227.
Head and Neck Cancer
Comparison of Intra-Arterial Cisplatin and RT to Other RTOG Regimens Using Standard or Accelerated RT with or without Concurrent Chemotherapy in Patients with Stage IV-T4 Head and Neck Cancer – Parvesh Kumar, M.D., University of Southern California – October 5, Poster Session, 4:30 PM, #2266.
Definitive Radiotherapy ± Erythropoietin for Squamous Cell Carcinoma of the Head and Neck: Preliminary Report of RTOG 99-03 – Mitchell Machtay, M.D., Thomas Jefferson University – October 5, Plenary Session, 10:08 AM, #5.
Quality of Life Variables Influence Local Regional Control in RTOG Head & Neck Trials (9003 and 9111) – Benjamin Movsas, M.D., Fox Chase Cancer Center – October 6, Session Y, 1:15 PM, #199.
Early Postoperative Paclitaxel Followed by Paclitaxel and Cisplatin Concurrent with RT (Phase II Trial RTOG H-0024) is Well Tolerated for Patients with Resected, High-Risk Squamous Carcinoma of the Head and Neck – David Rosenthal, M.D., University of Texas M.D. Anderson Cancer Center – October 6, Poster Discussion 8, 10:30 AM, #1111.
Endometrial Cancer
RTOG 9708: Adjuvant Postoperative Irradiation Combined with Cisplatin/Taxol Chemotherapy Following Surgery for Patients with High-Risk Endometrial Cancer – Kathryn Greven, M.D., Wake Forest University – October 6, Session Q, 10:40 AM, #137.
Metastatic Cancer
Can Physicians Accurately Predict Survival Time in Patients with Metastatic Cancer? Analysis of RTOG 9714 – William Hartsell, M.D., Advocate Lutheran General Hospital – October 4, Session C, 10:45 AM, #25.
Prospective Health-Related Quality of Life Valuations (Utilities) of 8 Gy in 1 Fraction Vs 30 Gy in 10 Fractions for Palliation of Painful Bone Metastases: Preliminary Results of RTOG 97-14 – Deborah Watkins Bruner, Ph.D., Fox Chase Cancer Center – October 4, Session C, 10:25 AM, #22.
Rectal Cancer
Results of RTOG-0012 Randomized Phase II Study of Neoadjuvant Combined Modality Chemoradiation for Distal Rectal Cancer – Mohammed Mohiuddin, M. D., University of Kentucky – October 4, Session B, 10:35 AM, #16.
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The Radiation Therapy Oncology Group (RTOG) is a clinical research component of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
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Hormone Therapy Fails to Cure Anemia In Head and Neck Cancer Patients
Atlanta, Ga. – October 5, 2004 – For head and neck cancer patients suffering from mild to moderate anemia, receiving human hormone therapy in addition to radiation therapy does not improve survival rates, according to a Radiation Therapy Oncology Group study presented at the Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in Atlanta. RTOG, an NCI-funded national clinical trials group, is a grantee organization of the American College of Radiology (ACR).
Anemia has been associated with poor local control and lower survival rates for patients with squamous cell carcinoma of the head and neck. Earlier studies have found that the human hormone erythropoietin helps raise hemoglobin levels in anemic patients receiving radiation therapy. This study set out to discover whether administering human erythropoietin would not only increase hemoglobin levels in anemic patients, but also improve cancer treatment response and control of the tumor.
Despite significantly improving hemoglobin levels in the 148 patients enrolled in the study, the addition of hormone therapy to radiation therapy failed to improve tumor control or survival rates. However, researchers did not find any statistically significant worsening of cancer outcomes in erythropoietin-treated patients, in contrast to a similar study published last year in The Lancet.
“We discovered that you can’t simply correct anemia and think that it will magically improve outcomes for those suffering from head and neck cancers,” said Mitchell Machtay, M.D., a radiation oncologist at Thomas Jefferson University in Philadelphia and lead author of the study. “This study suggests that the whole relationship between cancer, blood counts and the amount of oxygen in the tumor is far more complex than once thought.”
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The Radiation Therapy Oncology Group (RTOG) is a clinical research component of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
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Can Physicians Predict Survival Time for Patients with Metastatic Cancer?
Atlanta, Ga. – October 4, 2004 – Physicians can accurately predict which patients with metastatic cancer will live longer, but their predictions are often optimistic, according to a Radiation Therapy Oncology Group (RTOG) study presented at the Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in Atlanta. RTOG, an NCI-funded national clinical trials group, is a grantee organization of the American College of Radiology (ACR).
Almost 900 patients with metastatic breast or prostate cancer were entered on an RTOG study that compared two different radiation therapy treatment schedules. At the time of study entry the physician was required to predict the patient’s expected survival time and assign a baseline Karnofsky performance score (KPS) that assessed the patient’s ability to carry out normal everyday activities. The patient also completed a questionnaire designed to measure quality of life factors, the Functional Assessment of Cancer Therapy (FACT).
According to lead study author William Hartsell, M.D., of Advocate Lutheran General Hospital, “The patient’s baseline KPS and FACT scores as well as the physician’s prediction all correlated with actual survival. Physicians were able to accurately predict which patients would live longer, but they also tended to overestimate the actual survival time by an average of three months.”
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The Radiation Therapy Oncology Group (RTOG) is the clinical research component of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
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Chromosomal Deletions Found to Predict Survival in Malignant Brain Tumors
Atlanta, Ga. – October 4, 2004 – Brain tumor patients with anaplastic oligodendroglioma (AO) or mixed oligo-astrocytoma (MOA) who have lost genetic material in two of their chromosomes live longer whether treated with radiation therapy, chemotherapy or a combination of the two according to a Radiation Therapy Oncology Group (RTOG) study presented at the Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in Atlanta. RTOG, an NCI-funded national clinical trials group, is a grantee organization of the American College of Radiology (ACR).
RTOG member institutions randomized 291 AO and MOA patients on a study that compared radiotherapy alone to radiotherapy preceded by intensive chemotherapy. The authors found that patients with the chromosomal deletions (the short arm of chromosome 1 and the long arm of chromosome 19) have a longer survival time whether with treated with chemotherapy, radiation therapy, or both, compared to patients who do not have the chromosomal deletions. The 5-year survival rate for the patients without the deletions was 34 percent, compared to 68% for those with the deletions. The study also showed that the combination of chemotherapy and radiation therapy was able to delay time to tumor progression compared to radiation alone. However, the chemotherapy was associated with more side effects,
According to lead study author Edward G. Shaw, M.D., of Wake Forest University Baptist Medical Center in Winston-Salem, NC, “This study confirmed an earlier finding that specific chromosomal deletions can predict response to treatment and survival in patients with AO and MOA. With this finding, we have officially entered the era of molecular diagnosis and treatment of brain tumors, and greater promise of a cure".
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The Radiation Therapy Oncology Group (RTOG) is the clinical research component of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
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R. Suzanne Swann, Ph.D. Named New RTOG Group Statistician
Philadelphia, Pa. – June 7 , 2004 – R. Suzanne Swann, Ph.D. has been named the new RTOG Group Statistician and Senior Director, Statistics for the American College of Radiology. In her new position as Director of the ACR Statistical Unit, Dr. Swann will direct the statistical efforts for two of the College’s major grants from the National Cancer Institute, the Radiation Therapy Oncology Group (RTOG) and the Patterns of Care Study (PCS). Dr. Swann has been with ACR since April 2002, most recently as the Acting Director of Statistics for ACR.
Walter J. Curran, Jr., M.D., Group Chair of the RTOG and Clinical Director of the Kimmel Cancer Center at Thomas Jefferson University endorsed Dr. Swann’s appointment by saying, “During her tenure as Acting Director of Statistics, Suzanne played a major role in the reorganization of the RTOG Headquarters’ staff into disease site-based teams. This new organizational structure is designed to be more responsive to the needs of today’s clinical trials research community.”
According to Dr. Swann, "It is very rewarding to be a part of RTOG’s mission to improve cancer treatment and it is great to work with RTOG’s distinguished investigators in the US and Canada as well as the dedicated professionals on the staff of the RTOG and ACR."
“ACR, in conjunction with the leadership of RTOG and PCS conducted a national search for the new Senior Director of Statistics and we are quite pleased that Dr. Swann has accepted the position,” stated Thomas Caldwell, Assistant Executive Director of the ACR.
Prior to joining ACR, Dr. Swann was a research analyst for the South Carolina Rural Health Research Center. Dr Swann’s appointment was endorsed by the RTOG Steering Committee and other key RTOG, ACR, PCS, and NCI leaders. She replaces Charles Scott, Ph.D. who resigned from this position in July 2003.
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The Radiation Therapy Oncology Group (RTOG) is the clinical research component of the American College of Radiology (ACR), located in the ACR Philadelphia, PA office. RTOG is a multi-institutional international clinical cooperative group funded primarily by the National Cancer Institute. RTOG has over 30 years of experience in conducting clinical trials and is comprised of over 250 major research institutions in the United States and Canada. The group currently is conducting more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
The American College of Radiology (ACR) is a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.
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FOR IMMEDIATE RELEASE
New Standard for Voice Saving Care of Larynx Cancer Patients
Philadelphia - Results of an RTOG national clinical trial confirm that simultaneous
treatment with chemotherapy and radiation preserves the voice of patients with advanced larynx cancer without compromising survival rates. The findings, reported in the November 27, 2003 issue of the New England Journal of Medicine are compelling enough to have the combination treatment become the standard of care for such patients, the study’s authors report.
“Chemotherapy and radiation together are recommended for advanced laryngeal cancer
patients who are otherwise in good health and want to preserve their voice,” says RTOG Study Arlene Forastiere, M.D., professor of oncology and otolaryngology at the Johns Hopkins Kimmel Cancer Center. “For patients who have other significant medical problems or little support at home, we would recommend radiation alone. In all cases, patients should be followed closely during treatment by a head and neck surgeon, so that surgery can be performed if there is residual or recurrent cancer after treatment.”
This year, approximately 9,500 Americans will be diagnosed with laryngeal cancer and 3,800 will die from the disease.
Experience with combined treatment, Forastiere adds, has reduced the need for
complete removal of the larynx from 100 percent to about 15 percent. Removing the larynx leaves patients unable to speak with their natural voice and typically use speaking aids such as an electronic device. Other previously-studied treatment options included radiation therapy alone or several cycles of chemotherapy followed by radiation. Studies from a decade ago showed that the survival rate of patients treated with chemotherapy followed by radiation was just as good as those receiving surgery.
“RTOG clinical trial research is once again determining the standard of care for cancer
patients, said Walter J. Curran, Jr., M.D., RTOG Group Chair and Clinical Director of the
Kimmel Cancer Center at Thomas Jefferson University. “Our 30 years experience in head and neck cancer research has put us at the forefront of multi-modality oncology research.”
This new study of 547 patients entered on RTOG 9111 shows that giving chemotherapy
and radiation together instead of sequentially is more effective in preserving the voice box. Patients who received chemotherapy and radiation together still had their voice box after two years 88 percent of the time as compared to 75 percent for those who received chemotherapy followed by radiation and 70 percent for patients who received radiation alone. For each of these three treatment options, overall survival was similar at about 75 percent after two years.
“Giving chemotherapy with radiation at the same time makes cancer cells more
susceptible to radiation, so effectively more tumor cells are destroyed,” explains Forastiere.
The national study was the coordinated by the RTOG, with participation from its member
institutions and members of the Southwest Oncology Group (SWOG) and the Eastern
Cooperative Oncology Group (ECOG). The study was funded by the National Cancer Institute.
Study authors included Helmuth Goepfert, M.D., Moshe Maor, M.D., Randal Weber,
M.D., William Morrison, M.D., Bonnie Glisson, M.D., from the University of Texas M.D.
Anderson Cancer Center; Thomas F. Pajak, Ph.D., from the RTOG; Andy Trotti, M.D., from the H. Lee Moffitt Cancer Center and Research Institute; John A. Ridge, M.D., Ph.D., from the Fox Chase Cancer Center; Glen Peters, M.D., from the University of Alabama; Andrea Leaf, M.D., from the New York Harbor Healthcare System; John Ensley, M.D., from the Karmanos Cancer Institute at Wayne State University School of Medicine; Jay Cooper, M.D., from New York University Medical Center and Ding-Jen Lee, M.D., Ph.D., from the Johns Hopkins Kimmel Cancer Center.
On the web:
Radiation Therapy Oncology Group (RTOG): www.rtog.org
American College of Radiology (ACR): www.acr.org
Johns Hopkins Kimmel Cancer Center: www.hopkinskimmelcancercenter.org
New England Journal of Medicine: www.nejm.org
RTOG is a multi-institutional national clinical cooperative group funded by the National Cancer Institute and headquartered in the Philadelphia office of the American College of Radiology. RTOG has over 30 years of experience in conducting clinical trials and is comprised of 250 of the major research institutions nationally and in Canada. The group currently has more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
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FOR IMMEDIATE RELEASE
RTOG Once Again a Major Presenter at ASTRO Meeting
Philadelphia – October 15, 2003 – RTOG investigators are once again scheduled to be major presenters at the Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO). Sixteen abstracts based on RTOG clinical trials, including two of the five abstracts chosen for the Plenary Session, will be presented at the Salt Lake City meeting October 19 – 23, 2003. Twelve additional RTOG abstracts will be presented orally during the conference and two will be presented at an oral poster session.
The Plenary Session presentations include the results of two RTOG Phase III trials: RTOG 97-14, a study of 949 patients with painful bony metastases examining the benefit of radiation therapy delivered in one 8 Gy fraction versus 10 fractions of 2 Gy, presented by William Hartsell, M.D. of Advocate Lutheran General Hospital; and, RTOG 93-09, an Intergroup study of 429 patients assessing the benefits of concurrent chemotherapy and 61 Gy radiotherapy followed by surgical resection versus the same chemotherapy plus standard 45 Gy radiotherapy alone for stage IIIa non-small cell lung cancer, presented by Andrew Turrisi, M.D. of the Medical University of South Carolina.
The remaining oral and poster presentations revolve around RTOG’s decade’s-long research in CNS, head & neck, lung and prostate cancers. Attached is the complete list of RTOG presentations at ASTRO.
RTOG Presentations at ASTRO 2003
Bone Metastases
Randomized Trial of 8 Gy in 1 Fraction vs. 30 Gy in 10 Fractions for Palliation of Painful Bone Metastases –William Hartsell, M.D., Advocate Lutheran General Hospital – Plenary Session: October 20, 12:45 PM.
Brain Tumors
FISH Analysis of Genetic Markers of Prognosis for High Grade Astrocyotmas – Daniel J. Brat, M.D., Emory University – October 20, Session B, 11:05, #19.
Reexamining the RTOG Recursive Partitioning Analysis for Glioblastoma Multiforme Patients – Edward G. Shaw, M.D., Wake Forest University – October 20, Session B, 11:15, #20.
Phase I Results of an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, ZD 1839 (Iressa), with Radiation Therapy in Glioblastoma Multiforme – Arnab Chakravarti, M.D., Massachusetts General Hospital – October 23, Poster Session 9, 10:30, #1113.
Head and Neck Cancer
Impact of EGFR Expression on the Response of Advanced Head and Neck Carcinomas to Concomitant Boost Radiotherapy – X. Tu, M.D., M.D. Anderson Cancer Center – October 20, Session F, 3:50, #56.
Late Effects of Re-Irradiation and Chemotherapy in Patients with Squamous Cell Cancer of the Head and Neck – Sharon Spencer, M.D., University of Alabama – October 21, Poster Session 6, 11:30, #1077.
Lung Cancer
Acute and Late Toxicity Results of a Dose Escalation Study Using 3D Conformal Radiation Therapy in Patients with Inoperable Non-Small Cell Lung Cancer – Jeffrey Bradley, M.D., Washington University – October 20, Session C, 10:15, #23.
Amifostine as Mucosal Protectant in Patients with Locally Advanced Non-Small Cell Lung Cancer Receiving Intensive Chemotherapy and Thoracic Radiotherapy – Maria Werner-Wasik, M.D., Thomas Jefferson University Hospital – October 23, Session R, 10:30, #152.
Phase I Dose-Escalation Study of Thoracic Irradiation with Concurrent Chemotherapy for Patients with Limited Cell Lung Cancer – Ritsuko Komaki, M.D., M.D. Anderson Cancer Center – October 20, Session C, 10:35, #25.
Randomized Trial of Chemoradiotherapy to 61 Gy vs Chemoradiotherapy to 45 Gy Followed by Surgery Using Cisplatin Etoposide in Stage IIIa Non-Small Cell Lung Cancer: Intergroup Trial 0139, RTOG (93-09) – Andrew Turrisi, M.D., Medical University of South Carolina – Plenary Session Presentation, October 20, 12:45 PM.
Long Term Survival Results of Postoperative Adjuvant Paclitaxel/Carboplatin and Thoracic Radiotherapy in Resected Stage II and IIa Non Small Cell Lung Cancer – Mary Vogelsang Graham, M.D., Phelps County Regional Medical Center – October 20, Session C, 11:15, #28.
Prostate Cancer
Long Term Results of Adjuvant Androgen Suppression and Radiotherapy for Prostate Cancer – Miljenko Pilepich, M.D., St. Joseph Mercy Hospital – October 21, Session J, 11:30, #82.
Ki-67 Staining is a Strong Predictor of Patient Outcome for Prostate Cancer Patients Treated with Androgen Deprivation Plus Radiotherapy – Alan Pollack, M.D., Fox Chase Cancer Center – October 21, Session O, 2:30, #126.
Monte Carlo Simulation of a Markov Model for a Trial Evaluating the Addition of Total Androgen Suppression to Radiation for Locally Advanced Prostate Cancer – Andre Konski, M.D., Fox Chase Cancer Center – October 21, Session Q, 3:50, #151.
Toxicity Following 3D Radiation Therapy for Prostate Cancer – Jeff Michalski, M.D., Washington University – October 20, Session E, 3:30, #46.
Vascular Endothelial Growth Factor (VEGF) Expression in Locally Advanced Prostate Cancer – Lesley Hughes, M.D., Thomas Jefferson University Hospital – October 21, Session O, 2:48, #128.
Please visit the RTOG booth (#309) in the Exhibition Hall of the Salt Palace Convention Center. If you would like a copy of the RTOG abstracts presented at ASTRO contact Tom Wudarski in Philadelphia at (215) 574-3205, twudarski@phila.acr.org. If you would like to arrange to speak with the authors please visit the RTOG Booth or contact Sharon Hartson Stine at (609) 458-5604 on the convention floor or shartson@phila.acr.org.
RTOG is a multi-institutional national clinical cooperative group funded by the National Cancer Institute and headquartered in the Philadelphia office of the American College of Radiology. RTOG has over 30 years of experience in conducting clinical trials and is comprised of 250 of the major research institutions nationally and in Canada. The group currently has more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
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FOR IMMEDIATE RELEASE
RTOG NATIONAL MEETING IN MONTREAL
Philadelphia – June 20, 2003 – Cancer specialists from across the United States and Canada are convening this weekend at the Radiation Therapy Oncology Group (RTOG) semi-annual meeting at the Delta CentreVille, Montreal, Canada, June 26 through June 29, 2003. Over 600 member physicians, basic scientists and research assistants are expected to attend scientific presentations and working group sessions devoted to the RTOG cancer clinical trials research. Highlights of the meeting include:
Friday, June 27th, 10:00 AM – 3:00 PM
Symposium: Normal Tissue Biologic Response Modifiers Symposium
National and international investigators will review basic science discoveries ready for national clinical testing for the prevention and alleviation of treatment induced toxicity. The symposium will feature four sessions, each dedicated to a major disease site within the RTOG. Each session includes invited speakers, proffered papers, and a clinical representative for the disease site.
Symposium Chair: Paul Okunieff, M.D., University of Rochester, RTOG Translational Research Program Chair
Saturday, June 28th, 1:00 PM – 3:00 PM
RTOG General Scientific Session
Keynote Speaker: J. Donald Chapman, Ph.D., Fox Chase Cancer Center, Philadelphia
Hypoxia in Early Stage Prostate Cancer: Why the Alpha/Beta Ratio Might Not be Low?
Simon Kramer New Investigator Award:
Christopher H. Crane, M.D., M.D. Anderson Cancer Center, Houston, Texas
Preliminary Results of a Phase I Study of rhuMab VEGF (Bevacizumab) with Concurrent Radiotherapy (XRT) and Capecitabine (CAP).
Recent Research: Originally presented at the 2003 ASCO Annual Meeting.
Andrew Turrisi, M.D., Medical University of South Carolina, Charleston, SC
Phase III Comparison of Concurrent Chemotherapy Plus Radiotherapy (CT/RT) and CT/RT Followed by Surgical Resection for Stage IIIA(Pn2) Non-Small Cell Lung Cancer (NSCLC): Initial Results From Intergroup Trial 0139 (RTOG 93-09).
William Kraybill, M.D., Roswell Park Cancer Institute, Buffalo, NY
Radiation Therapy Oncology Group (RTOG) 9514: A Phase II Study of Neoadjuvant Chemotherapy (Ct) and Radiation Therapy (RT) in the Management of High Risk (HR), High Grade, Soft Tissue Sarcomas (STS) of the Extremities and Body Wall.
Howard Sandler, M.D., University of Michigan Medical Center, Ann Arbor, MI
Can Biochemical Failure (ASTRO Definition) Be Used as a Surrogate Endpoint for Prostate Cancer Survival in Phase III Localized Prostate Cancer Clinical Trials? Analysis of RTOG Protocol 92-02.
Maria Werner-Wasik, M.D., Thomas Jefferson University Hospital, Philadelphia, PA
Phase III Study of Amifostine in Patients with Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Receiving Chemotherapy & Hyperfractionated Radiation (CHEMO/HFXRT): Radiation Therapy Oncology Group (RTOG) 98-01.
During the three-and-a-half day meeting, disease site, quality of life, and modality-specific working groups and steering sessions are held continuously beginning at 8:00 AM. According to the RTOG Group Chair, Walter J. Curran, Jr., M.D. of Thomas Jefferson University, “The Group’s goal is to improve the chances of survival for patients with cancer. At our twice-yearly Group meetings we review our ongoing research and chart our future efforts to accomplish this goal. We hope that the research presented at this meeting will impact the treatment patterns for cancer patients.” RTOG will hold its next meeting January 15 – 18, 2004 at the New Orleans Sheraton, New Orleans, LA.
RTOG is a multi-institutional national clinical cooperative group funded by the National Cancer Institute and headquartered in the Philadelphia office of the American College of Radiology. RTOG has over 30 years of experience in conducting clinical trials and is comprised of 250 of the major research institutions nationally and in Canada. The group currently has more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
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FOR IMMEDIATE RELEASE
RTOG Contributes to 12 ASCO Presentations
CHICAGO – May 30, 2003 – RTOG investigators are the authors of five oral
presentations and two poster presentations at the upcoming Annual Meeting of the American Society for Clinical Oncology (ASCO) taking place in Chicago from May 31 to June 3, 2003.
RTOG has also contributed to four studies that will be reported by other clinical trial organizations. In addition, RTOG research first presented last fall at the annual meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO), will be highlighted at an ASCO “Best of Oncology” session on Monday, June 2nd at 4:00 PM.
“RTOG investigators continue to have a major impact on the conduct of cancer clinical research,” said Walter J. Curran, Jr., M.D., RTOG Group Chair and Clinical Director of the Kimmel Cancer Center at Thomas Jefferson University. “Not only are we at the forefront of radiation oncology research, but our multi-modality approach is defining cancer care in several disease sites. ”
RTOG Research at ASCO
• Prostate Cancer
Can Biochemical Failure (ASTRO Definition) Be Used as a Surrogate Endpoint for Prostate Cancer Survival in Phase III Localized Prostate Cancer Clinical Trials? Analysis of RTOG Protocol 92-02.
Oral Presentation #1529, Saturday, 1:30 – 1:45 PM, S100 (Grand Ballroom).
Presenter: Howard Sandler, M.D., University of Michigan Medical Center, Ann Arbor.
Authors: Sandler, H., Pajak, T., Hanks, G., Porter, A., DeSilvio, M. and Shipley, W.
Phase III Trial of Androgen Suppression Adjuvant to Definitive Radiotherapy. Long Term Results of RTOG Study 85-31.
Oral Presentation #1530, Saturday, 2:00 – 2:15 PM, S100 (Grand Ballroom).
Presenter: Miljenko Pilepich, M.D., St. Joseph Mercy Hospital, Ann Arbor.
Authors: Pilepich, M., Winter, K., Lawton, C., Krisch, R., Wolkov, H., Movsas, B., Hug, E., Asbell, S. and Grignon, D.
• Lung Cancer
Phase III Comparison of Concurrent Chemotherapy Plus Radiotherapy (CT/RT) and CT/RT Followed by Surgical Resection for Stage IIIA(Pn2) Non-Small Cell Lung Cancer (NSCLC): Initial Results From Intergroup Trial 0139 (RTOG 93-09).
Oral Presentation #2497, Sunday, 7:45 - 8:00 AM, E Hall D1.
Presenter: Kathy S. Albain, M.D., Stritch School of Medicine of Loyola University, Chicago.
Authors: Albain, K. S., Scott, C., Rusch, V., Turrisi III, A. T., Shepherd, F., Smith, C., Gandara, D., Johnson, D., Green, M. and Miller, R.
Long-Term Benefit is Observed in a Phase III Comparison of Sequential vs Concurrent Chemo-Radiation for Patients with Unresected Stage III NSCLC: RTOG 94-10.
Oral Presentation #2499, Sunday, 8:30 - 8:45 AM, E Hall D1.
Presenter: Walter J. Curran, Jr., M.D., Thomas Jefferson University Hospital, Philadelphia.
Authors: Curran, W., Scott, C., Langer, C., Komaki, R., Lee, J., Hauser, S., Movsas, B., Wasserman, T., Sause, W. and Cox, J.
Phase III Study of Amifostine in Patients with Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Receiving Chemotherapy & Hyperfractionated Radiation (CHEMO/HFXRT): Radiation Therapy Oncology Group (RTOG) 98-01.
Poster Presentation #2559, Tuesday, 8:00 AM – Noon, S402.
Presenter: Benjamin Movsas, M.D., Fox Chase Cancer Center, Philadelphia.
Authors: Movsas, B., Scott, C., Langer, C., Werner-Wasik, M., Nicolaou, N., Komaki, R., Machtay, M., Axelrod, R. and Byardt, R.
Phase I Dose-Escalation Study of Thoracic Irradiation with Concurrent Chemotherapy for Patients with Limited Small Cell Lung Cancer (LSCLC). Radiation Therapy Oncology Group (RTOG) Protocol 97-12.
Poster Presentation #2539, Tuesday, 8:00 AM – Noon, S402.
Presenter: Ristko Komaki, M.D., M.D. Anderson Cancer Center, Houston.
Authors: Komaki, R., Swann, S., Ettinger, D., Glisson, B., Sandler, A., Movsas, B. and Byhardt, R.
• Sarcoma
Radiation Therapy Oncology Group (RTOG) 9514: A Phase II Study of Neoadjuvant Chemotherapy (Ct) and Radiation Therapy (RT) in the Management of High Risk (HR), High Grade, Soft Tissue Sarcomas (STS) of the Extremities and Body Wall.
Oral Presentation #2497, Sunday, 12:24 – 1:00 PM, E451.
Presenter: William Kraybill, M.D. Roswell Park Cancer Institute, Buffalo.
Authors: Kraybill, W., Harris, J., Spiro, I., Ettinger, D., Trotti, A., Lucas, D., Blum, R., Letson, D. and Eisenberg, B.
• Best of Oncology
Larynx preservation and tumor control in stage III and IV laryngeal cancer: a three-arm randomized intergroup trial; RTOG 91–11
Special Session: Monday, 4:00 – 5:30 PM, N Hall B1.
RTOG Discussant: Moshe Maor, M.D. Originally presented at ASTRO 2002.
Authors: Maor, M., Berkey, B., Forastiere, A., Weber, R., Goepfert, H., Morrison, W., Glisson, B., Trotti, A., Ridge, J., Chao, C., Peters, G., Lee, D., Leaf, A., Ensley, J. and Fu, K.
• Contributions to Other Research Groups
Intergroup 0144 - Phase III Trial of 5-FU Based Chemotherapy Regimens Plus Radiotherapy (XRT) in Postoperative Adjuvant Rectal Cancer. Bolus 5-FU vs Prolonged Venous Infusion (PVI) Before and After XRT + PVI vs Bolus 5-FU + Leucovorin (LV) + Levamisole (LEV) Before and After XRT + Bolus 5-FU + LV.
Oral Presentation #1006, Sunday, 1:00 – 1:15 PM, E Hall D2.
Presenter: Stephen R. Smalley, M.D., Southwest Oncology Group.
Authors: Smalley, S., Benedetti, J., Williamson, S., Robertson, J., Fisher, B., Martenson, J., Benson, A., Mayer, R., Cripps, C. and Macdonald, J.
Isotretinoin Effects on Head and Neck Cancer Recurrence and Second Primary Tumors.
Oral Presentation #359, Sunday, 2:00 – 2:15 PM, S105.
Presenter: Fadlo Khuri, M.D., M.D. Anderson Cancer Center.
Authors: Khuri, F., Lee, J. J., Lippman, S. M., Kim, E. S., Cooper, J., Benner, S., Vokes, E., Pajak, T., Goepfert, H. and Hong, W. K.
Comparison of Survival of Patients in the Phase I Study of Motexafin Gadolinium (MGD) with Radiation Therapy (RT) for Glioblastoma Multiforme (GBM), with a Matched Cohort of Patients from the RTOG RPA Glioma Database.
Poster Presentation #425, Sunday 8:00 AM – Noon, S104.
Presenter: Judith M. Ford, M.D., University of California Los Angeles.
Authors: Ford, J., Seiferheld, W., Mehta, M., Phan, S. and Curran Jr, W.
Adjuvant Radiotherapy (PORT) or Chemoradiotherapy (CPORT) Following Resection of Stages II And IIIa Non-Small Cell Lung Cancer (NSCLC) Leads to Higher Than Expected Risk of Death From Intercurrent Disease (DID).
Poster Presentation #2545, Tuesday, 8:00 AM – Noon, S402.
Presenter: Heather A. Wakelee, M.D., Easter Cooperative Oncology Group (ECOG).
Authors: Wakelee, H., Stephenson, P., Keller, S., Wagner, H., Herskovic , A., Komaki, R., Marks, R., Perry, M., Livingston, R. and Johnson, D.
Copies of the RTOG abstracts presented at ASCO are available after they have been presented. For further information about RTOG, copies of group publications, or to make arrangements to speak with an RTOG investigator, please contact Tom Wudarski, Group Administrator at (215) 574-3205, twudarski@phila.acr.org.
RTOG is a multi-institutional national clinical cooperative group funded by the National Cancer Institute and headquartered in the Philadelphia office of the American College of Radiology.
RTOG has over 30 years of experience in running clinical trials and is comprised of 250 of the major research institutions nationally and in Canada. The group currently has more than 40 active studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient.
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