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David K. Gaffney, M.D., Ph.D., Chair
Dr. Deborah Bruner-Watkins presented an educational talk on sexuality in gynecologic cancer patients. Quality of Life issues were discussed. This was well received by the members in attendance. Quality of Life issues will be an important part of the cancer control protocol evaluating different schedules of vaginal brachytherapy.
Dr. Portelance discussed RTOG 0418. The endometrial cancer portion of the protocol has been closed and accrued rapidly. The cervix cancer portion of the protocol is ongoing. Dr. Portelance reported the quality assurance techniques are working very well including the three-dimensional viewing tool.
Dr. Janice Kwan updated the group on RTOG 0417. The protocol passed the first scheduled toxicity analysis. Dr. Kwan encouraged the group to continue microarray sample collection and to perform image guided brachytherapy on this protocol.
RTOG 0724 was described by Dr. Jhingran. The design of this protocol is extended adjuvant chemotherapy after hysterectomy in patients with node positive cervical cancer. The current design is extended adjuvant chemotherapy versus no further treatment. Additionally, there will be a second randomization to bevacuzimab or not. Hence, this is a 2 x 2 design. This trial will be presented to the GOG. The NCRI has indicated interest in working together with us on this concept.
Dr. Bill Small updated the group on cancer control protocol RTOG 0818 evaluating different schedules of vaginal brachytherapy. Dr. Small indicated the prescription point would likely be the vaginal surface and most likely there will be three fractions of vaginal brachytherapy versus six fractions of vaginal brachytherapy. The primary endpoint of this trial will be vaginal shortening.
Next Dr. Souhami presented a concept evaluating definitive brachytherapy for endometrial cancer in the elderly. Excellent background exists for this concept. A difficulty with this concept as expressed in the steering committee is accrual of patients in this particular subset.
Dr. de los Santos presented a concept evaluating IMRT in intact cervix cancer. A working group will convene at the next RTOG meeting to discuss mobility issues and issues relating to how to perform IMRT in cervix cancer. The group was enthusiastic about moving forward with this concept.
A concept was presented evaluating IMRT and targeted therapy in endometrial cancer. It was noted chemotherapy is showing increasing benefits in patients with endometrial cancer. Additionally, the population of patients tends to be elderly and have multiple comorbidities making the delivery of chemotherapy difficult. Additionally, the IMRT portion of RTOG 0418 accrued rapidly, and, hence, combining the IMRT and targeted therapy appears worthwhile in this disease. The membership was enthusiastic about moving forward with this concept.
Dr. Joe Hsu presented a concept involving image guided brachytherapy in advanced cervix cancer. Dr. Hsu's concept includes two brachytherapy insertions. The patient stayed in the hospital overnight and a total of four brachytherapy fractions are delivered prescribing 7 Gy each. Many members express difficulty about regarding obtaining MRIs still in their institutions.
Collaboration with GOG was discussed. RTOG 0724 will be presented at the GOG meeting next week, which will also be in San Diego. A stage III endometrial concept (UC0704) has been developed by the GOG evaluating chemotherapy in surgically staged stage III patients followed by plus or minus radiotherapy. It is likely the radiotherapy arm will consist of concurrent chemoradiotherapy. GOG 238 is a randomized phase II trial of radiotherapy plus or minus chemotherapy given in a concurrent fashion. This trial will open promptly. Trial UC0604 is a trial of pelvic radiotherapy versus vaginal brachytherapy plus chemotherapy. This is an approved concept via the GOG. It is likely this trial will open in six to 12 months. The RTOG Gynecologic Cancer Working Group expressed interest in participating in UC0704, UC0604, and RTOG 0238. GOG/ACRIN 0233 is a study evaluating the sensitivity and specificity of PET and MRI in cervix cancer patients. It was felt this was largely a radiologic question in patients treated with surgery and as radiation oncologists we would be able to contribute little to this study.
Dr. Joanne Weidhaas gave an update on the Translational Research Program. She encouraged participation in RTOG 0418. Seed grants have been funded to Drs. Tony Magliocco, Corrine Dahl, and Dr. Weidhaus.
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David K. Gaffney, M.D., Ph.D., Chair
RTOG 0418 was discussed. The endometrial arm of the protocol has been closed after more than 46 evaluable patients had been accrued. The endometrial portion has accrued faster than expected. Approximately 16 patients have been accrued to the cervical cancer arm. No specific problems with enrollment were identified.
Dr. Tracey Schefter discussed RTOG 0417. To date, seven patients have been accrued. Approximately 50 centers have put the trial through their IRB. One issue was brought forth impeding enrollment and that was the date prior to enrollment at which a biopsy could be obtained. It was felt reasonable to remove this requirement or change it to three months prior to enrollment. Membership was encouraged to accrue vigorously to this trial. It does compete with GOG 219, and this was a problem in some centers.
Dr. Gaffney discussed a clinical trial brought forth by investigators from Europe titled the EMBRACE study involving the feasibility of MRI image guided brachytherapy. Few centers currently have access to MRI for each implant. The group was encouraged to participate in image guided brachytherapy and additionally to support the image guided amendment on RTOG 0417.
Dr. Charlie Pan gave an update on the ACRIN/RTOG proposal looking a DCE-MRI and PET scanning for carcinoma of the cervix. Dr. Mustafa Atri is the ACRIN PI. The timing of brachytherapy was discussed, and the uniformity of dose prescription. It was felt most reasonable to perform the first brachytherapy procedure at week four and to have the initial PET scan immediately prior to this.
Dr. Bill Small presented different schedules of vaginal brachytherapy. This is an ongoing proposal with the Cancer Control Committee. The group was enthusiastic about participation. The group felt it was important to carry if not prescribe dose to the vaginal surface. No specific problems were identified with prescribing three fractions versus six fractions.
Dr. Anuja Jhingren presented a concept for extended adjuvant chemo after chemoradiotherapy in cervical cancer patients treated with radical hysterectomy. The group was enthusiastic. This proposal has received support from the GOG, NCRI, and EORTC. This will be forwarded to the RTOG Steering Committee.
RTOG/GOG collaboration. The group was encouraged to participate in GOG protocols 209 and to support 219 if did not conflict at their center with RTOG 0417. Four trials are in development using, in part, radiotherapy for the treatment of endometrial cancer. The group was encouraged to participate with the GOG on these developing studies.
Next, Dr. Joann Weidhaas gave an update on the TRP program. Sample collection is proceeding nicely on RTOG 0417.
Dr Aaron Wolfson gave a presentation on the ASTEC/EN.5 and Hogberg NSGO trials which were just presented at ASCO. Dr. Wolfson served as the commentator for these trials. The audience enjoyed the presentation and this data may inform clinical trial design in the future.
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David K. Gaffney, M.D., Ph.D.
Dr. David Gaffney gave a summary of the endometrial cancer state of the science meeting which was held at the end of November in Manchester, United Kingdom. A slide set was provided by Dr. Ted Trimble from the NCI as well as Dr. Henry Kitchner from the NCRI. Next, Dr. Bill Small indicated progress on RTOG 0116. One patient remains to be accrued to this trial. He indicated the trial would stay open until 3/1/07. Next, Dr. Jhingran provided an update of protocol RTOG 0418. Thirty patients had been accrued out of 46 to the endometrial cancer arm and eight of 46 patients had been accrued to the cervix cancer arm. No untoward effects had been described to date. Dr. Tracy Shefter then updated the group on protocol RTOG 0417. This trial is a phase II protocol employing radiotherapy, cisplatin, and bevacizumab in advanced cervix cancer. Participation was encouraged to utilize all aspects of the study including tissue collection such as fresh tissue for microarray gene expression analysis and cera and urine. Additionally, participation in the image guided brachytherapy portion of the trial was encouraged as well.
Several proposals were entertained. Dr. Charlie Pan from the University of Michigan provided an update on the status of the ACRIN/RTOG proposed imaging study employing DCE MRI, and PET. There was high enthusiasm for this protocol. Dr. Bill Small provided a proposal for evaluating two different schedules of vaginal brachytherapy in endometrial cancer. He also described a cancer control protocol forwarded by Dr. Deborah Bruner-Watkins describing use of a vaginal dilator after hysterectomy and radiotherapy. Dr. Viswanathan provided an update on a proposed trial for stage I through III carcinosarcoma. The proposed design was chemoradiotherapy versus vaginal brachytherapy and chemotherapy. Similarly, a stage III endometrial cancer design was proposed to the group. In this trial, the chemoradiotherapy arm would be identical to RTOG 9708 and the control arm would be chemotherapy. Carboplatin and Taxol were suggested as the standard chemotherapy. Dr. Yashar described a possible collaborative protocol for higher intermediate risk stage I and II endometrial cancer. The two study arms would be pelvic radiotherapy versus vaginal brachytherapy and 3 cycles of chemotherapy.
Dr. Weidhaas provided an update on the translational research program activities. The importance of sample collection was emphasized. The group was encouraged to participate and was invited to attend TRP meetings. Lastly, Dr. Beth Erickson provided an educational session on image guided brachytherapy. The opened imaging amendment was discussed and the group was encouraged to fully participate.
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David K. Gaffney, M.D., Ph.D., Chair
Open protocols were discussed first. Dr. Small updated protocol RTOG 0116. Two patients are remaining on protocol. We anticipate this protocol will close soon.
Next, Dr. Portland and Dr. Jingren updated the group on recently open protocol RTOG 0418. This protocol is pelvic IMRT after hysterectomy for endometrial or cervical carcinoma. Institutions will be required to be credentialed if they have not been credentialed for IMRT treatments to the pelvis. The first case will be a rapid review. The study opened in March and currently two patients are on protocol.
Next, Dr. Shefter updated the group on the pending protocol RTOG 0417 which is radiotherapy, cisplatin and bevacizumab in advanced cervical carcinoma. Image guided brachytherapy amendment is appended to this protocol. Dr. Erickson updated the group on requirements for performing image guided brachytherapy. MRI was stressed. Additionally, microarray gene expression analysis will be performed. In protocol RTOG 0417, Dr. Joann Weidhaus updated the group on sample collection and the importance of continuing to perform microarray expression analysis in cervical carcinoma specimens.
Dr. Gaffney updated the group on protocol RTOG 0128. The trial is closed and the first report of efficacy will be presented at ASTRO in Philadelphia in November 2006.
Proposals were discussed. Dr. Charlie Pan from the University of Michigan discussed an imaging protocol may be sponsored by ACRIN. In this protocol, patients will have a PET CT and diffusion contrast enhanced MRI pretreatment, prior to brachytherapy, and possibly three months after treatment. The group was enthusiastic for this protocol. It was hoped therapy can be individualized depending upon the PET or MRI results.
Next, Dr. Bill Small presented a concept regarding two different schedules of vaginal brachytherapy as a cancer control protocol with the primary endpoint being vaginal toxicity. This protocol would run through the cancer control committee. The discussion took place in regards to the appropriate device to measure vaginal length and elasticity. Dr. Small will present this protocol to the cancer control committee. The group was supportive of these efforts.
Dr. Joann Weidhaas updated the group on the translational research program. A seed grant has been funded to perform validation of gene expression analysis. Additionally, a tissue microarray has been constructed in RTOG 0128, and the group was informed of the availability of this resource.
Secondary studies were discussed. Dr. Arno .J. Mundt and Dr. Bill Small in conjunction with others constructed a CTV atlas for the posthysterectomy pelvis. In addition, members of the RTOG Gynecologic Cancer Working Group were involved in a GCIG (gynecologic cancer intergroup) survey. Abstracts will be presented at the International Gynecologic Cancer Society in cervix cancer and one in endometrial cancer. Additionally, other secondary analyses were encouraged such as brachytherapy quality in previous protocols.
Dr. Anthony Fyles from Princess Margaret Hospital delivered an educational session titled “Advances in Gynecologic Radiation Oncology at Princess Margaret Hospital”. Dr. Fyles described advances in radiobiologic research performed at Princess Margaret Hospital along with promising phase II trials performed by their group. The talk was well received by the committee.
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David K. Gaffney, M.D., Ph.D., Chair
Dr. Bill Small presented open protocol RTOG 0116. The protocol is accruing to the Amifostine arm at the current time. Accrual is slow. Enthusiasm for the protocol continues to be high.
Pending Protocols
Dr. Jingran indicated protocol RTOG 0418 regarding IMRT after hysterectomy and cervical and endometrial cancer has gone to CTEP. Dr. Jingran described the appropriate way to simulate a patient. Patients will be simulated in the supine position. Images will be obtained with a full and empty bladder, and the vaginal volume will be an ITV. The requirement regarding the margin status was discussed. In the Peters, et al trial, positive margins were allowed. It was felt reasonable by the group to consider including positive margin patients for the trial since a vaginal brachytherapy boost is optional. The ITC turnaround time is predicted to be three days, which was acceptable to the group.
Dr. Tracy Shefter presented RTOG 0417. The letter of intent has previously gone to CTEP. In one month, the protocol will be required to be sent to CTEP. The inclusion criteria will be the same as RTOG 0128. In the TRP meeting, the TRP leadership indicated support for obtaining samples of urine, sera, and fresh tissue on RTOG 0417. In this protocol, there will be an image guided brachytherapy amendment. Dr. Erickson has been critically involved in this process. Images can be obtained volumetrically with either CT or MR. It was indicated MR was preferred. The group was encouraged to participate in the image guided brachytherapy portion.
Dr. Gaffney briefly described the status of the closed protocol RTOG 0128. Disease free survival data should be available in the few months. An abstract will be forthcoming. Phase III concepts were presented.
Dr. Lorraine Portelance presented a concept of vaginal brachy versus IMRT for early endometrial cancer. The group was most comfortable proceeding with a possible disease free survival endpoint in a high intermediate category of early endometrial cancer patients. The concept will continue in development.
Additionally, Dr. Luis Souhami presented data on RSR13. This molecule is an allosteric modifier of hemoglobin and increases the oxygenation to tumors. There is a trial in brain metastases, which shows a benefit for a sub-category of patients with breast cancer. A phase II trial is in progress in cervix cancer with this agent. An inconvenience regarding this specific agent is it is required to be given IV prior to treatment daily. There is moderate enthusiasm regarding the concept of this trial.
Suggested changes to the FIGO staging system were briefly presented by Jennifer De los Santos. Recommendation to categorize patients into three categories for stage I and stage II cervical tumors were described.
Dr. Joann Weidhaas was introduced as the TRP liaison.
Dr. Joe Hsu gave an educational session regarding MRI brachytherapy. He presented developments in Europe and in America regarding MRI based brachytherapy treatment planning.
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David K. Gaffney, M.D, Ph.D., Chair
Dr. Bill Small presented the open protocol RTOG 0116. It was hoped this trial will come to completion in the next several months or within the year.
The pending protocols were discussed. RTOG 0418 was discussed by Dr. Anuja Jhingran. The optimal dose of 45 versus 50.4 Gy was discussed. Additionally, the membership felt the optional use of vaginal brachytherapy was desirable for this patient population. The vaginal target volume will be an integrated target volume.
Dr. Janice Kwon presented developing protocol RTOG 0417. In this protocol, the experimental agent is bevacizumab or Avastin. An image guided brachytherapy amendment was discussed by Dr. Beth Erickson. Additionally, the committee felt it would be reasonable to have a PET scan prior to treatment and at three months post follow-up to evaluate for patterns of failure.
Dr. Gaffney presented closed protocol RTOG 0128. This will be presented at ASTRO 2005 for the primary end point.
Dr. Catherine Yashar presented a proposal for premetrexed and cisplatin in advanced cervix cancer. The data from other studies has shown it is relatively non-toxic and appears to have additivity when combined with cisplatin.
Dr. Aaron Wolfson will lead an effort to suggest changes to FIGO regarding staging for cervix cancer.
Quality of Life studies were endorsed by the group. No specific concept was endorsed.
Dr. Gaffney updated the group on the translational research program. Involvement of others was requested. Description of tissue micro-arrays was performed. Solicitations for proposals for tissue micro-array analyses were made as well.
Dr. Marvin Rotman presented a history of the RTOG gynecologic cancer working group. He described the early history of the group with developing philosophies in the US, England, France, and MD Anderson. He described early insights of Dr. Gilbert Fletcher. This was warmly received by the membership.
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David K. Gaffney, M.D., Ph.D., Chair
The two CO-chairs of the committee were introduced: Dr. Bill Small from Northwestern University and Dr. Bridget Miller from Wake Forest University. The members present were asked whether they wanted to be included in the Gynecologic Cancer Committee and if so to please include their name on a list that was circulated.
RTOG 0116 - Dr. Bill Small discussed this trial, which is currently accruing to the second part of the phase II protocol (Amifostine arm). Accrual is slow at this point since opening. It does not appear omission of IMRT is a major hurdle to accrual. It was discussed in some centers utilization of Amifostine is encouraged off protocol and, consequently, the group was encouraged to continue accrual to acquire useful data for women receiving pelvic radiotherapy.
RTOG 0128 - Dr. Gaffney discussed this trial, which closed prematurely due to safety information that was recently made available regarding Celecoxib. In a recent placebo controlled randomized trial, there was an increased hazard ratio of cardiovascular events of 2.5 for the patients on the Celecoxib arm. On a second randomized placebo controlled trial employing Celecoxib, there was no significant increase in cardiovascular event. It was recommended by RTOG to terminate the Celecoxib on this trial, since the significant aim of the trial has been completed. Approximately seven patients were still on the medicine with one month or less before completion. The group was reminded this was the first successful attempt by the RTOG to perform microarray. An abstract was presented at ASTRO, and a manuscript was accepted in Gynecologic Oncology describing the feasibility of this approach in the cooperative group setting.
Dr. Schefter described developing protocol RTOG 0417, a biologic protocol for the treatment of advanced cervical carcinoma. Gefitinib was the proposed study agent for this trial. In a recent randomized trial, there was no statistically significant benefit to the primary end point of the trial regarding Gefitinib. This was widely discussed amongst the committee as well as receiving input from the National Cancer Institute. It was felt to be high risk to proceed with development of a protocol evaluating Gefitinib and, consequently, the group endorsed proceeding with a randomized phase II design of Erlotinib (Tarceva) and Bevacizumab (Avastin).
Dr. Gaffney indicated RTOG headquarters endorsed the image guided brachytherapy amendment. Half of a case credit and additional monetary funds were granted from headquarters for each patient placed on the imaging amendment proposed by Dr. Erickson. Members were encouraged to acquire MR compatible applicators if possible. They were also reminded CT images were allowed.
Dr. Jhingran updated the group on the developing protocol RTOG 0418. This study is evaluating IMRT for post hysterectomy patients after surgery for endometrial cancer or cervical carcinoma. The cervix cancer patients will receive weekly Cisplatin chemotherapy as well. This study will require the coordination of the ATC.
Dr. Mahesh Varia gave a presentation on hypoxia, and specifically measuring hypoxia intracellularly with the compound Pimonidazole. In addition to data regarding Pimonidazole, Dr. Varia updated the group on other measurements of hypoxia in cervix cancer including oxygen electrode probes, endogenous markers, and functional imaging.
Dr. Bridget Miller provided data on a radiosensitizing compound, Curcurmin. In preclinical models, this has shown moderate to strong radiosensitization. It appears the absorption of the compound is irregular.
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David K. Gaffney, M.D., Ph.D.
The first item on the agenda was discussion of the closed protocol, RTOG 0128. The protocol was for advanced cervix cancer and consisted of 5-FU, Cisplatin, standard radiotherapy, and daily Celecoxib at 400 mg b.i.d. The trial accrued 83 patients in 31 months. The average accrual was 2.6 patients per month. Once the drug company provided the study compound, accrual was good overall at approximately five patients per month, and in one month’s period of time, a total of 10 patients were accrued. Additionally, fresh tissue was obtained both prior to treatment and at the time of the first brachytherapy implant in approximately one-third of the patients. The study is too premature to present the primary objectives of the study. However, it is hoped an abstract may be able to be prepared for the ASCO meeting. Dr. Gaffney presented these findings.
Dr. Bill Small from Northwestern University discussed protocol RTOG 0116. The study is temporarily on hold and will be sent back to CTEP at the NCI for consideration of reopening. Dr. Bill Small carefully reviewed the toxicity associated with the trial. In preliminary conversations with the NCI, there was hope they would allow the study to proceed to the second phase of the trial where Amifostine will be tested to attempt to decrease acute and late toxicities.
Dr. Tracy Shefter from the University of Colorado discussed pending protocol RTOG 0417. The schema for this protocol is standard radiotherapy plus weekly Cisplatin at 40 mg/m2 times six plus Gefitinib (Iressa) at 250 mg daily for one year. The group was in agreement or proceeding with this trial, and there was support for this being the highest priority agenda item for the Gynecologic Cancer Committee. Next, Dr. Anuja Jhingran presented the other approved protocol, which is pending. In this trial, a feasibility trial will be performed evaluating IMRT to the pelvis in women, who undergo hysterectomy for endometrial cancer or cervical carcinoma. Discussion ensued regarding appropriate volumes to treat.
Dr. Rosenzweig from GPC Biotech presented data on satraplatin. This is an oral platinum agent has promise for the treatment of cervical carcinoma.
Dr. Patricia Eifel from MD Anderson Cancer Center presented a power point presentation on the pitfalls of brachytherapy. This was highly informative to the audience. Dr. Eifel thoroughly went through appropriate applications and misapplications of brachytherapy in the treatment of cervical carcinoma.
Dr. Bill Small also presented data on Alimta as a potential agent to be used in the treatment of cervical carcinoma.
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Kathryn Greven, M.D., Chair
1. Open Trials
Dr. Bill Small discussed RTOG 0116. Amendments are being prepared in order to move forward to subcutaneous Amifostine administration.
Dr. David Gaffney discussed RTOG 0128. Accrual has improved and the trial is expected to be completed in less than one year. Unfortunately toxicity seems to be an issue and is felt to be related to the 5FU.
2. Proposed Cervical Trial
A phase II trial will probably follow the Celebrex trial. Investigation will need to determine the biologic modifier that will be used.
A discussion with presentations by Drs. David Gaffney, Arno Mundt, Anuja Jhingran, and Lorraine Portelance concerning IMRT for pelvic malignancies was held. Advantages of IMRT may be decrease of pelvic toxicity. A proposal was made to form a group in order to develop an IMRT protocol for postoperative cervical and endometrial.
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Kathryn Greven, M.D., Chair
Open Protocols:
RTOG 9905-The slow rate of accrual was discussed. Members were encouraged to recruit patients.
RTOG C128-Dr. Gaffney discussed lack of serious morbidity thus far. Celebrex is being provided for patients. Recruitment of patients was encouraged. Amendments are needed to the protocol.
RTOG C116- Dr. Small discussed the incidence of grade 3 and 4 toxicity. Most of it is hematologic. It was proposed to eliminate hematologic toxicity involving neutophils as being a limiting toxicity since growth factors can be given and it is an anticipated toxicity. The next phase of the protocol is being written and will include the use of subcutaneous Amifostine.
Developing Protocols:
Dr. Greven solicited concepts for endometrial cancer. Concepts involving IMRT were encouraged. Dr. Erickson presented updates on the developing protocol of establishing a film library of brachytherapy placements. Technical factors need to be worked out. A written document is being generated.
Others: Dr. Nag presented the outcome of the 3D brachytherapy planning discussion from Vancouver last summer. It was still advised to prescribe intracavitary placements using standard points. He discussed the collection and location of other points, based on imaging of placements, that could be collected for later analysis.
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Kathryn Greven, M.D., Chair
The agenda for the meeting included reviewing the current open trials.
RTOG 99-05 – This study is not accruing as well as anticipated. Suggestions were made to allow vaginal brachytherapy and change the pathology definition to correspond with endometrioid tumors as defined by GOG. RTOG 01-16 has begun accrual and final plans for delivering Amofostine need to be worked out. RTOG 01-28 is accruing and we are working on a deal to provide Celebrex to patients which is almost complete. Dr. Gaffney emphasized the importance of obtaining pathologic specimens and stated that an amendment was being developed to not make them mandatory and to provide cash and/or case credit reimbursement if provided.
Dr. Mohiuddin presented information on a recently opened phase I GOG trial for ovarian cancer using low dose hyperfractionated radiation. Because the RTOG membership does not see many of these patients it will not be opened as a cooperative effort.
Dr. Gillin presented a companion study that is being developed for 116 and 128 to build a film library of brachytherapy placements in order to correlated doses to 3rd treatment volumes with currently used point A and B doses. Further investigation will be done for feasibility and the concept will be presented at research strategy.
Dr. Cardenes presented a proposal for low risk endometrial cancer patients randomizing patients between vaginal brachytherapy and no further treatment. Although it was agreed that the concept was good, the number of patients required would be too large to complete in the RTOG.
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Kathryn Greven, M.D., Chair
Closed trials that were reviewed including RTOG 97-08. Members were encouraged to submit appropriate follow up forms in a timely fashion. The results will be presented at ASTRO in the fall of this year.
Open studies discussed included RTOG 99-05 which is phase three intergroup study with GOG which randomizes uterine-confined endometrial cancer patients to treatment with radiation alone or radiation with chemotherapy. Accrual has been increasing. It is hoped that with the participation of GOG that accrual will continue. RTOG C-108 was discussed which is a phase three GOG trial that randomizes advanced endometrial cancer patients with radiation and Adriamycin and Cisplatin or radiation Cisplatin and Adriamycin and Taxol. This has been recently been made available to members. Dr. Beth Erickson will serve as the RTOG PI. She did discuss the trial and encouraged participation by membership.
Protocols to be activated shortly include the RTOG cervix trial by David Gaffney with Cox 2 inhibitor Celebrex. Dr. Gaffney reviewed the treatment protocol of this plan. Dr. Karen Zempolich from The University of Utah reviewed tissue micro array and biopsy chemical stains that will be done on the tissue collected on these patients. This protocol is anticipated to open very soon. The next protocol is Dr. Bill Small’s protocol with para aortic positive nodes treated with Amofostine. Details on the Amofostine treated have not been completely worked out. We would like to go ahead and open this protocol since the first phase of this protocol the patients do not receive Amofostine.
Proposed studies, Dr. Beth Erickson proposed a study for patients undergoing chemotherapy and radiation on Bill Small’s protocol and David Gaffney’s protocol which would involve getting CT scans of brachytherapy insertions. This would help to better define dose distribution and could be correlated ultimately with local regional control as well as toxicity. She has formed a working group which is very active in developing this study. The outcomes of this study could lead to a film bank which could be used retrospectively to look at additional indicators in the future. We will discuss this at the next research strategy meeting.
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Kathryn Greven, M.D., Chair
At the beginning of the meeting closed studies were reviewed including RTOG 97-08. This is a study of adjuvant postoperative radiation with Cisplatin/Taxol chemotherapy for patients with high-risk endometrial cancer. Toxicity has been updated and found to be acceptable. The majority of the toxicity was hemalogic. Outcomes as far as survival and disease free survival were not available. This study has been used to develop the phase III study, is RTOG 99-05.
RTOG 99-05 was reviewed with the committee. This is a study that has been approved by the NCI that will be a randomized study for patients with endometrial cancer confined to the uterus, consisting of pelvic radiation versus pelvic radiation Platin/Taxol. The GOG has agreed to participate in this study however, is not pleased with the dose of Taxol that has been written. The dose of Taxol is 175 mg per meter squared over twenty-four hours. The Medical Oncology Committee was consulted earlier and they felt that a more standard way of delivering the dose would be with a three-hour infusion. It was agreed to change this dose to three-hour infusion and possibly change the dose to 160 mg per meter square, which is a similar dose that GOG is proposing in their advanced endometrial cancer study. Dr. Fred Stehman was agreeable with this change and the membership was agreeable.
Dr. Perry Grigsby presented the proposed GOG endometrial cancer study for advanced endometrial cancer patients. On this study patients will received pelvic or para-aortic and pelvic radiation and be randomized to receive platinum andriamycin or platinum andriamycin and Taxol. There is some discussion about whether chemotherapy was standard in this group of patients. However, the membership in general agreed to proceed with participating in this study.
Dr. Adam Dicker spoke about the new information concerning Cox -II inhibitors in the treatment of various malignancies. He presented information suggesting that cervix cancer may be an ideal situation to test this drug since there are markers that would be available and the cervix is a relatively simple place to obtain tissue. Dr. David Gaffney confirmed that he had tested patient’s slides at the University of Utah and found that the presence of Cox-II receptors were prognostic for outcome. There was a fair amount of interest from the committee and it was agreed to take this to Research Strategy to see whether there would be interest in proceeding with a phase II protocol for evaluation of Cox-II inhibitors with Cisplatin and radiation for intact cervix patients.
Dr. Bill Small presented his protocol RTOG 1052 for patients with positive para-aortic or common iliac nodes from cervical cancer. Statistics has suggested that a large number of patients would be necessary to complete this trial. He will be working with Kathryn Winter and Dr. J.D. Lu with some new information that has been published in the Journal of Clinical Oncology to see whether a better estimate can be arrived at.
Dr. Cliff Chao was not available to talk about his study with oral Fluoropyrimidine. There has been a problem recently with Orzel not being FDA approved. There have been some discussions with Roche as well as Bristol about the potential availability of the drug.
Dr. Lori Wenzel discussed her plans for developing an RO1 grant in order to follow the survivors of RTOG 90-01. There was enthusiasm for doing this study. It was also suggested that incorporating other intergroup studies might make a stronger study since the number of the patients might be difficult to acquire.
Dr. Mohiuddin discussed an ovarian proposal for using low dose whole abdominal radiation as a potential for Taxol in patients with high risk or recurrent ovarian cancer. There was a fair amount of enthusiasm generated over this proposal. A feasibility questionnaire will be sent out to the membership.
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