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
OBJECTIVES:
Primary
- To evaluate the rate of freedom from radical cystectomy at 3 years.
Secondary
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Rate of freedom from radical cystectomy at 3 years
No
William U. Shipley, MD, FACR
Study Chair
Massachusetts General Hospital
Unspecified
CDR0000654727
NCT00981656
November 2009
Name | Location |
---|---|
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 |