|Phase II||Treatment||Completed||18 and over||NCI||RTOG-8512|
I. Refine criteria for identifying the population of patients with carcinoma of the bladder who can be treated with radiotherapy and chemotherapy with a high probability of permanent tumor control. II. Evaluate the toxicity of combined radiotherapy and chemotherapy with cis-platinum both as preoperative and definitive treatment. III. Determine the complete regression rate for all patients on study. IV. Determine the degree of pathologic tumor downstaging for patients who achieve an incomplete regression with cis-platinum and radiotherapy and require cystectomy.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Patients with documented transitional cell carcinoma, squamous cell carcinoma, or adenocarcinoma of the bladder who have evaluable residual tumor in the bladder following initial TUR and who are suitable candidates for radical cystectomy. Patients must have invasive tumors confined to the pelvis that, in the opinion of the urologist, require cystectomy. Disease must be Stage B, C, or D1 (Marshall-Jewett) or T2-4, N0, NX, N+ (pelvis) (AJC). Staging will be clinical, based on examination under anesthesia and transurethral resection. Evidence of tumor spread beyond the pelvis, including lymph nodes above the aortic bifurcation, excludes. Patients must have a Karnofsky performance status of at least 70%, a serum creatinine value of less than 2.0, a 24-hour creatinine clearance of at least 60 cc/minute, a hemoglobin of greater than 10 g, a WBC of greater than 4,000, and platelets greater than 100,000. Bilirubin, alkaline phosphate, and SGOT must be less than twice normal. Prior radiotherapy, chemotherapy, or surgery for bladder carcinoma (other than TUR) excludes. Patients with clinically significant hearing deficit, prior or concurrent other malignancy except nonmelanomatous skin cancer, myocardial infarction within the past year, or medical problems that might interfere with protocol treatment or follow-up are ineligible.
Approximately 74 patients will be accrued to provide 67 evaluable cases.
Nonrandomized study. All patients are treated on Regimen A, and those who achieve a complete regression proceed to Regimen B. Patients with incomplete regression after Regimen A enter Regimen C. Regimen A: Preliminary Radiotherapy plus Single-agent Chemotherapy. Irradiation of the bladder and regional lymphatics using effective photon energies of 1.25 MeV or higher; plus cis-Platinum, CACP, NSC-119875. Regimen B: Consolidation Radiotherapy plus Single-agent Chemotherapy. Irradiation of the bladder and extravesical tumor extensions; plus CACP. Regimen C: Surgery. Radical cystectomy.Published Results
Tester W, Porter A, Asbell S, et al.: Combined modality program with possible organ preservation for invasive bladder carcinoma: results of RTOG protocol 85-12. Int J Radiat Oncol Biol Phys 25 (5): 783-90, 1993.[PUBMED Abstract]
Trial Lead Organizations
Radiation Therapy Oncology Group
|William Tester, MD, Protocol chair|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.