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
- 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
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Rate of freedom from radical cystectomy at 3 years
William U. Shipley, MD, FACR
Massachusetts General Hospital
|University of Texas Medical Branch||Galveston, Texas 77555-1329|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Beth Israel Medical Center - Petrie Division||New York, New York 10003-3803|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|Cancer Treatment Center||Wooster, Ohio 44691|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|Barberton Citizens Hospital||Barberton, Ohio 44203|
|Cancer Care Center, Incorporated||Salem, Ohio 44460|
|Hudner Oncology Center at Saint Anne's Hospital - Fall River||Fall River, Massachusetts 02721|
|Emory Crawford Long Hospital||Atlanta, Georgia 30308|
|St. Agnes Hospital Cancer Center||Baltimore, Maryland 21229|
|Norris Cotton Cancer Center - North||Saint Johnsbury, Vermont 05819|