|
| RTOG 0232 |
|---|
| Number: | RTOG 0232 |
| Title: |
A Phase III Study Comparing Combined External Beam Radiation And Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone For Selected Patients With Intermediate Risk Prostatic Carcinoma |
| Eligibility: |
Histologically confirmed, locally confined adenocarcinoma of the prostate; Clinical stages T1c-T2b; Zubrod 0-1; Age > 18 years; Combined Gleason 7 if PSA < 10, combined Gleason < 7 if PSA 10-20; PSA must be < 20ng/mL, before hormone therapy, if given (if Gleason 2-6, then PSA must be > 10 ng/mL; Prostate volume by TRUS < 60 cc; No prior chemotherapy, pelvic radiation, no prior TURP, cryosurgery, TUNA, TUMT or radical surgery for carcinoma of the prostate; No previous hormonal therapy beginning < 2 months or > 6 months prior to registration; No distant metastases, no clinically or pathologically involved lymph nodes; No significant obstructive symptoms; AUA must be < 15 (alpha blockers allowed); No hip prosthesis; No major medical or psychiatric illness; Study-specific informed consent form signed prior to study entry.
|
| RT |
Arm 1: 45 Gy EBRT, partial pelvis (1.8 Gy/fraction M-F for 5 weeks) followed 2-4 weeks later by Pd-103 (100 Gy) or I-125 (110 Gy)*
Arm 2: Pd-103 (125 Gy) or I-125 (145 Gy)*
*Protocol treatment must begin within 4 weeks after study entry.
|
| Study size: | 586 |
| RTOG 0524 |
|---|
| Number: | RTOG 0524 |
| Title: |
A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer |
| Eligibility: |
Pathologically (histologically or cytologically) proven diagnosis of primary bladder transitional cell carcinoma with histologic evidence of muscularis propria invasion OR patients with stage T1, grade 3/3 as described in Section 3.1.5; Patients must be judged to be medically inappropriate for radical cystectomy; Patients must have undergone as thorough a TURB by a participating urologist as is judged safely possible. Bimanual examination by a participating urologist must have been performed, with tumor mapping as specified in Appendix V. (See Section 4.1.3); There must be sufficient tumor tissue available for her2/neu analysis; Based on the American Joint Committee on Cancer (AJCC), 6th edition (Appendix III): stage of transitional cell carcinoma (TCC) must be stages T2-T4a; Nx, N0 or N1; and M0; OR patients with primary bladder TCC grade 3/3 with AJCC clinical stage T1 who are felt to require definitive local therapy. Patients who have involvement of the prostatic urethra with TCC that was visibly completely resected, and have no evidence of stromal invasion of the prostate, remain eligible. They may not have evidence of distant metastases as determined by the following staging studies: Chest x-ray (or chest CT scan) within 8 weeks prior to registration, Abdominal/pelvic CT scan within 8 weeks prior to registration; History and physical examination including vital signs and body surface area within 4 weeks prior to registration; Zubrod performance status of < 2 (Appendix II); Age > 18; CBC/differential < 2 weeks prior to registration, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) 1,800 cells/mm3, Platelets 100,000 cells/mm3, Hemoglobin 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb 8.0 g/dl is acceptable); Adequate renal function, with serum creatinine < 3.0 mg/dl; Adequate liver function, with serum bilirubin < 2.0 mg/dl and SGOT/SGPT < 2.5 x the upper normal limit; EKG and either MUGA scan or echocardiogram within 8 weeks prior to study entry; Adequate left ventricular ejection fraction (EF) by either MUGA scan or echocardiogram, with minimum EF of 40%; Patients must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy by the joint agreement of the participating radiation oncologist and medical oncologist; Protocol treatment should begin within 3 to 12 weeks of the most recent TURB; Patient must sign a study-specific informed consent prior to study entry; Negative pregnancy test for female patients of childbearing potential within 2 weeks prior to study entry; Women of childbearing potential and male participants must practice adequate contraception.
|
| Treatment: |
Group 1: Patients with her2/neu overexpression
Radiation Therapy
1.8 Gy qd for 5 fx/wk, for a total of 36 fx (1.8 Gy small pelvic fields x 22 fx, then reduction for 1.8 Gy x 8 fx, then 1.8 Gy boost x 6 fx for a total dose of 64.8 Gy)
Chemotherapy
Paclitaxel: d 1, 8, 15, 22, 29, 36, 43
Trastuzumab: d 1, 8, 15, 22, 29, 36, 43
Group 2: Patients without her2/neu overexpression
Radiation Therapy
1.8 Gy qd for 5 fx/wk, for a total of 36 fx (1.8 Gy small pelvic fields x 22 fx, then reduction for 1.8 Gy x 8 fx, then 1.8 Gy boost x 6 fx for a total dose of 64.8 Gy)
Chemotherapy
Paclitaxel: d 1, 8, 15, 22, 29, 36, 43
|
| Study size: | 88 |
| RTOG 0526 |
|---|
| Number: | RTOG 0526 |
| Title: |
A Prospective Phase II Trial Of Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy |
| Eligibility: |
Biopsy-documented locally recurrent prostatic adenocarcinoma > 30 months after the completion
of EBRT, biopsied 180 days prior to registration and confirmed by central pathology review;
Disease-related characteristics at initial diagnosis (i.e., prior to EBRT) that fit one of the following
categories (Appendix III):
- Stages T1-T2c, Gleason scores 2-6, and PSA 20 ng/mL, or
- Stages T1-T2c, Gleason score 7, and PSA 10 ng/mL
Staging, performed within 8 weeks prior to registration:
- History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen)
- Negative lymph nodes by imaging (pelvic abdominal CT or MR), or by nodal dissection (laparoscopy or laparotomy)
- No evidence of bone metastases (M0) on bone scan
Zubrod Performance Scale 0-1; Age > 18; Baseline serum PSA value < 10 ng/mL performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 8 weeks prior to registration. PSA should not be performed within 10 days of a prior prostate biopsy, and if the patient has been started on hormonal therapy, the PSA should be performed within 8 weeks prior to the commencement of hormonal therapy; Prostate volume as measured by transrectal ultrasound (TRUS) < 45 cc; Patient must be suitable for spinal or general anesthesia;
No prior invasive (except non-melanoma skin cancer) or hematological (e.g., acute leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for a minimum of 3 years. Previous diagnosis of low-grade lymphoma or chronic lymphocytic leukemia is allowed; No prior
EBRT to the prostate that exceeded 78 Gy (2 Gy fractions) or 79.8 Gy (1.9 Gy fractions) or 81 Gy (1.8 Gy fractions); No baseline gastrointestinal (GI) or genitourinary (GU) toxicity (for any reason) grade 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) v3.0; No severe, active comorbidity as defined in the protocol; No clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis (i.e., prior to EBRT) or at time of local recurrence (i.e., prior to study registration); No histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1); None of the following prior therapies:
- Transurethral resection of the prostate (TURP); Radionuclide (permanent or temporary implantation) prostate brachytherapy ; Prostatectomy or prostatic cryosurgery; HIFU (high-intensity focused ultrasound); Bilateral orchiectomy; Chemotherapy for prostatic carcinoma
NOTE 1: Androgen suppression therapy is permissible provided that the LHRH agonist was started at least 2 months and no more than 6 months before registration.
NOTE 2: Any combination of neoadjuvant, concurrent, or adjuvant androgen suppression therapy at the time of initial external radiotherapy is permissible provided the total duration was < 8 months.
|
| Treatment: |
PRIOR TO EXTERNAL RADIOTHERAPY
T1-T2c, GS 2-6, PSA < 20 ng/mL
OR
T1-T2c, GS 7, PSA < 10 ng/mL
LOCAL RECURRENCE
>30 months after external radiotherapy
PSA < 10
STEP 1 REGISTER
Central pathology review confirmed
STEP 2 REGISTER
Prostate brachytherapy*
|
| Study size: | 96 |
| RTOG 0534 |
|---|
| Number: | RTOG 0534 |
| Title: |
A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy |
| Eligibility: |
Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e., lymph node dissection is not required; Any type of radical prostatectomy will be permitted. If performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator vs. extended lymph node dissection) should be noted; Post-radical prostatectomy entry PSA of > 0.1 and < 2.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration; One of the following pathologic classifications: T3N0/Nx disease or T2N0/Nx disease with or without positive prostatectomy surgical margin; Prostatectomy Gleason score of 8 or less; Zubrod Performance Status of 0-1; Age > 18; Digital rectal exam within 8 weeks prior to registration; No distant metastases, based upon the minimum diagnostic workup defined in the protocol; Adequate bone marrow function, within 90 days prior to registration, defined as follows: Platelets > 100,000 cells/mm3 based upon CBC; Hemoglobin > 10.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb > 10.0 g/dl is recommended). AST or ALT < 2 x the upper limit of normal within 90 days prior to registration; Serum total testosterone must be > 40% of the lower limit of normal of the assay used within 90 days prior to registration; patients must be able to provide study-specific informed consent prior to study entry.
No palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer; N1 patients are ineligible, as are those with pelvic lymph node enlargement > 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative; No androgen deprivation therapy started prior to prostatectomy for > 6 months duration; No androgen deprivation therapy started after prostatectomy and prior to registration; No prior pelvic radiotherapy; No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the oral cavity is permissible); No severe, active co-morbidity, as defined in the protocol; No prior allergic reaction to the study drug(s) involved in this protocol.
|
| Treatment: |
Arm 1: PBRT Alone*
PBRT 64.8-70.2 Gy
Arm 2: PBRT + NC-STAD
PBRT 64.8-70.2 Gy + NC-STAD for 4-6 months, beginning 2 months before RT
Arm 3: PLNRT + PBRT + NC-STAD
PLNRT to 45 Gy and PBRT to 64.8-70.2 Gy, NC-STAD for 4-6 months, beginning 2 months before RT
*SV = seminal vesicle; RT = radiotherapy; PBRT = prostate bed RT; PLNRT = pelvic lymph node RT; NC-STAD = neoadjuvant and concurrent short term androgen deprivation
|
| Study size: | 1764 |
| RTOG 0612 |
|---|
| Number: | RTOG 0612 |
| Title: |
Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study |
| Eligibility: |
Patient must be eligible for RTOG 0232. Patient must be enrolled on RTOG 0232. Submission of the paraffin tissue block from initial diagnosis. Submission of the biopsy specimen that contains frozen tissue. Patient must sign a study-specific informed consent for RTOG 0612 prior to study entry.
|
| Study size: | 96 |
| RTOG 0621 |
|---|
| Number: | RTOG 0621 |
| Title: |
Adjuvant 3DCRT/IMRT in Combination with Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial |
| Eligibility: |
Pathologically proven diagnosis of adenocarcinoma of the prostate gland at the time of prior radical prostatectomy meeting one of the following combinations:
- Pathologic Gleason > 7 and post-operative PSA nadir > 0.2 ng/ml with any pT classification;
- Pathologic Gleason > 8, post-operative PSA nadir < 0.2 ng/ml and > pT3a classification.
Enrollment must occur within 1 year from radical prostatectomy. Study entry PSA must be obtained within 6 weeks (42 days) prior to registration. Zubrod Performance Status 0-1; Age > 18; no lymph node or distant metastases (N0, M0), based upon the diagnostic workup specified in the protocol. Adequate bone marrow function as defined in the protocol. Testosterone obtained within 28 days prior to registration on study. Serum ALT, AST, alkaline phosphatase, bilirubin obtained within 28 days prior to registration on study. Evaluation and approval for study participation by a medical oncologist prior to registration. Patient must provide study-specific informed consent prior to study entry. No prior invasive malignancy unless disease free for a minimum of 3 years. No prior systemic chemotherapy for the study cancer. No prior androgen deprivation for treatment of prostate cancer. No prior use of hormonal agents such as finasteride or dutasteride for treatment of benign prostatic hypertrophy is allowed. No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. No severe, active co-morbidity as defined in the protocol. No prior allergic reaction to the study drug(s) involved in this protocol.
|
Androgen Suppression
And RT
And Docetaxel |
LHRH Agonist and Non-Steroidal Antiandrogen for 6 months
RT: 66.6 Gy/1.8 Gy/fraction, starting 8 weeks after initiation of androgen suppression
Docetaxel, starting 3-6 weeks after completion of radiation, Day 1 of each 21-day cycle x 6 cycles
|
| Study size: | 76 |
| RTOG 0622 |
|---|
| Number: | RTOG 0622 |
| Title: |
A PHASE II TRIAL OF SAMARIUM 153 FOLLOWED BY SALVAGE PROSTATIC FOSSA 3D-CRT OR IMRT IRRADIATION IN HIGH-RISK, CLINICALLY NON-METASTATIC PROSTATE CANCER AFTER RADICAL PROSTATECTOMY |
| Eligibility: |
Pathologically (histologically) proven diagnosis of prostate cancer progressing after radical prostatectomy as indicated by one of the following: Postoperative PSA rising above 2.0 ng/ml; or Postoperative PSA rising above 0.2 ng/ml with a surgical tumor Gleason score of 9 or 10. Pathologic stage T2 -T4 N0 - N1, with no distant metastases, based upon the following minimum diagnostic workup: History/physical examination within 8 weeks prior to registration; Bone scan negative for bone metastases within 4 months prior to registration; Abdominal imaging negative for metastases within 6 months prior to registration. Zubrod performance status 0-1. Age >18. CBC/differential and PSA obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows: Absolute Neutrophil Count (ANC) >1,800 cells/mm3; Platelets >100,000 cells/mm3; Hemoglobin (Hgb) >8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >8.0 g/dl is permitted). Patient must be able to provide study specific informed consent prior to study entry.
|
| Treatment: |
Pre-local irradiation bone-targeted treatment with Samarium 153 as a single I.V. injection of 2.0 mCi/kg.
Evaluate for toxicity and PSA response at 12 weeks.
Prostatic Fossa 3D-CRT or IMRT Radiation Therapy (64.8 to 70.2 Gy).
Evaluate for toxicity and PSA response at 24 weeks.
If no response to prior therapy, then hormonal therapy.
|
| Study size: | 76 |
| RTOG 0712 |
|---|
| Number: | RTOG 0712 |
| Title: |
A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy |
| Eligibility: |
Pathologically (histologically or cytologically) proven diagnosis of primary carcinoma of the bladder (transitional cell cancer) within 6 weeks of registration. Operable patients whose tumors are primary carcinomas of the bladder and exhibit histologic evidence of muscularis propria invasion and are AJCC clinical stages T2-T4a, Nx or N0, M0 (Appendix IV) without hydronephrosis; patients who have involvement of the prostatic urethra with transitional cell cancer (TCC) that was visibly completely resected and no evidence of stromal invasion of the prostate remain eligible. (T2a, T2b, T3a, T3b "substages" are not usually able to be determined with clinical (TURBT) staging. If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases will not be eligible.
Patients must have an adequately functioning bladder after thorough evaluation by an urologist and have undergone as thorough a transurethral resection of the bladder tumor as is judged safely possible. Patients must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy by the joint agreement of the participating Urologist, Radiation Oncologist, and Medical Oncologist. History and physical examination including weight, performance status, and body surface area within 8 weeks prior to study registration. Zubrod Performance Status < 1. Age > 18. CBC/differential obtained no more than 4 weeks prior to registration on study, with adequate bone marrow function defined per protocol. Serum creatinine of 1.5 mg% or less; serum bilirubin of 2.0 mg% or less; creatinine clearance of 60 ml/min or greater.
Serum pregnancy test for female patients of childbearing potential, < 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception.
Patient must be able to provide study-specific informed consent prior to study entry.
|
| Treatment |
Arm 1 (Induction and Consolidation):
5-Fluorouracil (5-FU), Cisplatin
Irradiation bid
Arm 2 (Induction and Consolidation):
Gemcitabine
Irradiation qd
Re-examination of bladder:
If tumor has completely disappeared, same chemotherapy and radiation + cisplatin and gemcitabine
If tumor has not completely disappeared, surgical removal of bladder + cisplatin and gemcitabine
|
| Study size: | 98 |
| RTOG 0815 |
|---|
| Number: | RTOG 0815 |
| Title: |
A Phase III Prospective Randomized Trial Of Dose-Escalated Radiotherapy With Or Without Short-Term Androgen Deprivation Therapy For Patients With Intermediate-Risk Prostate Cancer |
| Eligibility: |
Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma within 6 months prior to registration at intermediate risk for recurrence as determined by having one or more of the following intermediate-risk features: Gleason Score 7; PSA >10 but <20; Clinical Stage T2b-T2c. Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration, except as noted in protocol Section 3.1.2. No evidence of bone metastases (M0) on bone scan within 60 days prior to registration. History/physical examination (to include, at a minimum, digital rectal examination of the prostate and examination of the skeletal system and abdomen, and formal comorbidity assessment via the ACE-27 instrument) within 60 days prior to registration; Zubrod Performance Status 0-1; Age > 18. Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration. Note: Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT; (3) within 30 days after discontinuation of finasteride; or (4) within 90 days after discontinuation of dutasteride. CBC/differential obtained within 60 days prior to registration (for patients undergoing brachytherapy only), with adequate bone marrow function as defined in protocol Section 3.1.8. Patient must be able to provide study-specific informed consent prior to study entry.
No patients with all three intermediate risk factors who also have > 50% of the number of their biopsy cores positive for cancer are ineligible for this trial. No prior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted). No prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer. No prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy. No use of finasteride within 30 days prior to registration or use of dutasteride within 90 days prior to registration. No prior or concurrent cytotoxic chemotherapy for prostate cancer. No prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT fields. No severe, active co-morbidity, as defined in protocol Section 3.2.9. No men who are sexually active with a woman of child-bearing potential and not willing/able to use medically acceptable forms of contraception (e.g., surgical, barrier, medicinal) during protocol treatment and during the first 3 months after cessation of protocol treatment.
|
| Treatment |
Stratify by Number of Risk Factors; Comorbidity Status; RT Modality
Arm 1: Dose-escalated RT alone
Arm 2: Dose-escalated RT combined with short-term (6 months) androgen blockade (LHRH agonist + antiandrogen)
|
| Study size: | 1520 |
| RTOG 0926 |
|---|
| Number: | RTOG 0926 |
| Title: |
A Phase II Protocol For Patients With Stage T1 Bladder Cancer To Evaluate Selective Bladder Preserving Treatment By Radiation Therapy Concurrent With Cisplatin Chemotherapy Following A Thorough Transurethral Surgical Re-Staging |
| Eligibility: |
Pathologically (histologically or cytologically) proven diagnosis of carcinoma of the bladder within 10 weeks prior to registration. Patients must have a T1G2 or T1G3 transitional cell carcinoma that has recurred within 18 months after initial treatment for < T1 tumors (TURBT and intravesical BCG immunotherapy) or have presented to a participating urologist who judged BCG therapy is contraindicated because this patient may be immuno-compromised in ways other than that mentioned in the protocol. With the presentations as described in the protocol, the participating urologist judges that the standard next therapy, based on present urologic guidelines for this patient, is radical cystectomy. If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or by percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases will not be eligible. Patients must have an adequately functioning bladder as judged by the participating urologist and radiation oncologist and have undergone a re-staging TURBT by the participating urologist that showed (or was present in the outside pathology specimen) a T1G2 or T1G3 tumor with uninvolved muscularis propria in the specimen and, if on prostatic urethral biopsy mucosal carcinoma is present, there is no evidence on biopsy in the prostatic stroma of tumor invasion. Patient must be considered able to tolerate systemic cisplatin chemotherapy combined with pelvic radiation therapy, and a radical cystectomy (if necessary) by the joint agreement of the participating urologist, radiation oncologist, and medical oncologist. Appropriate stage for protocol entry, based upon the minimum diagnostic workup described in the protocol. Zubrod Performance Status < 1. Age > 18. CBC/differential obtained no more than 4 weeks prior to registration on study, with adequate bone marrow function as defined in the protocol. Serum creatinine of < 1.5 mg%; serum bilirubin of < 2.0 mg%. Serum pregnancy test for female patients of childbearing potential, < 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception. Patient must be able to provide study-specific informed consent prior to study entry.
No patients with evidence of tumor-related hydronephrosis. No evidence of distant metastases or histologically or cytologically proven lymph node metastases. No prior systemic chemotherapy for bladder cancer; prior chemotherapy for a different cancer is allowable. No prior or concurrent malignancy of any other site or histology unless disease-free for > 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix. No patients judged not to be candidates for radical cystectomy; patients with pN+ or > T1 disease or who have not had a visibly complete TURBT. No patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside). No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. No severe, active co-morbidity as defined in the protocol. No transmural myocardial infarction within the last 6 months. No acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. No Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. No Aquired Immune Deficiency Syndrome (AIDS) based upon the current CDC definition. No pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception. No prior allergic reaction to the study drug (cisplatin) involved in this protocol.
|
| Treatment: |
Institutional TURBT for re-staging
Full-dose Radiation and Concurrent Cisplatin Chemotherapy
Cystoscopic Surveillance 8-10 weeks after treatment
(If negative, q 3 months for the 1st year, q 4 months for year 2, q 6 months for years 3, 4, and 5 and then annually)
|
| Study size: | 37 |
|
|
|
|
