Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, mitomycin C, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well radiation therapy given together with chemotherapy works in treating patients with stage I bladder cancer.
|Bladder Cancer||Drug: cisplatin Drug: fluorouracil Drug: mitomycin C||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging|
- Rate of freedom from radical cystectomy at 3 years [ Time Frame: Three years from the date of registration. ]
- Rate of freedom from radical cystectomy at 5 years [ Time Frame: Five years from the date of registration. ]
- Rate of freedom from the development of distant disease progression at 3 and 5 years [ Time Frame: From the date of registration to the date of first appearance of disease in a non-regional lymph node, solid organ or bone within 3 years and 5 years after registration. ]
- Rate of freedom from progression of bladder tumor to stage T2 or greater at 3 and 5 years [ Time Frame: From the date of registration to the date of first documented increase of 50% or more in the largest diameter of the endoscopically appreciable tumor or the progression from stage T1 to stage T2 or beyond within 3 years and 5years afeter registration. ]
- Disease-specific survival at 5 years [ Time Frame: From the date of registration to the date of death due to bladder cancer. ]
- Overall survival [ Time Frame: From the date of registration to the date of death due to any cause. ]
- Incidence of adverse events as assessed by Common Toxicity Criteria for Adverse Effects (CTCAE), v3.0 [ Time Frame: From the date of registration to the date of Grade 3 or more adverse events based on the active version of CTCAE among all eligible patients. ]
- Recurrence rate of any local bladder tumor [ Time Frame: From the date of registration to the date of first documented local bladder recurrence. ]
- Descriptive analysis for American Urological Association symptom score at baseline and at 3 years [ Time Frame: From the date of registration to 3 years after registration. ]
|Actual Study Start Date:||November 2009|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: TURBT + Concurrent RT + Chemotherapy
Transurethral resection of the bladder tumor (TURBT) + Concurrent Radiation Therapy (RT) + Chemotherapy
Given IVDrug: fluorouracil
Given IVDrug: mitomycin C
- To evaluate the rate of freedom from radical cystectomy at 3 years.
- To evaluate the rate of freedom from radical cystectomy at 5 years.
- To evaluate the rate of freedom from the development of distant disease progression at 3 and 5 years.
- To evaluate the rate of freedom from progression of bladder tumor to stage T2 or greater at 3 and 5 years.
- To evaluate disease-specific survival and overall survival.
- To evaluate the incidence of acute and late pelvic toxicity.
- To evaluate the efficacy of this treatment approach in preventing the recurrence of any local bladder tumor.
- To evaluate the potential value of tumor histopathology plus molecular genetic, DNA content, and urine proteomics parameters as possible significant prognostic factors for tumor control with this treatment approach.
- To collect American Urological Association symptom scores at baseline and at 3 years.
OUTLINE: Beginning within 10 weeks of transurethral resection of the bladder tumor, patients undergo 3-dimensional conformal radiotherapy once daily 5 days per week during weeks 1-7 (34 fractions). Patients also receive 1 of 2 radiosensitizing chemotherapy regimens concurrently with radiotherapy.
- Regimen I: Patients receive cisplatin IV on days 1-3 of weeks 1, 3, and 5.
- Regimen II: Patients receive mitomycin C IV on day 1 of radiotherapy and fluorouracil IV continuously over days 1-5 of weeks 1 and 4.
Patients with a persistent tumor on re-evaluation may undergo radical cystectomy.
Tissue, blood, and urine samples may be collected periodically for biomarker and other analysis.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981656
|United States, Georgia|
|Emory Crawford Long Hospital||Recruiting|
|Atlanta, Georgia, United States, 30308|
|Contact: Peter J. Rossi 404-686-4411|
|Winship Cancer Institute of Emory University||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Clinical Trials Office - Winship Cancer Institute 404-778-1900|
|United States, Maryland|
|St. Agnes Hospital Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21229|
|Contact: Richard S. Hudes, MD 410-368-2965|
|United States, Massachusetts|
|Hudner Oncology Center at Saint Anne's Hospital - Fall River||Recruiting|
|Fall River, Massachusetts, United States, 02721|
|Contact: Clinical Trials Office - Hudner Oncology Center at Saint Anne' 508-674-5600 ext 2019|
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03756-0002|
|Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 firstname.lastname@example.org|
|United States, New York|
|Beth Israel Medical Center - Petrie Division||Recruiting|
|New York, New York, United States, 10003-3803|
|Contact: Clinical Trials Office - Beth Israel Medical Center - Petrie D 212-844-6286|
|United States, Ohio|
|Summa Center for Cancer Care at Akron City Hospital||Recruiting|
|Akron, Ohio, United States, 44309-2090|
|Contact: Clinical Trials Office - Akron City Hospital 330-375-6101|
|Barberton Citizens Hospital||Recruiting|
|Barberton, Ohio, United States, 44203|
|Contact: William F. Demas, MD 330-375-3557|
|Cancer Care Center, Incorporated||Recruiting|
|Salem, Ohio, United States, 44460|
|Contact: William F. Demas, MD 330-375-3557|
|Cancer Treatment Center||Recruiting|
|Wooster, Ohio, United States, 44691|
|Contact: Clinical Trials Office - Cancer Treatment Center 330-375-4221|
|United States, Pennsylvania|
|Fox Chase Cancer Center - Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790|
|United States, Texas|
|University of Texas Medical Branch||Recruiting|
|Galveston, Texas, United States, 77555-0361|
|Contact: Clinical Trials Office - University of Texas Medical Branch 409-772-1950|
|United States, Vermont|
|Norris Cotton Cancer Center - North||Recruiting|
|Saint Johnsbury, Vermont, United States, 05819|
|Contact: Alan C. Hartford, MD, PhD 603-650-6600|
|Principal Investigator:||William U. Shipley, MD, FACR||Massachusetts General Hospital|