Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy drugs directly into the bladder may kill more cancer cells. It is not yet known if surgery followed by chemotherapy is more effective than chemotherapy alone in treating bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy alone with that of transurethral resection followed by chemotherapy in treating patients who have bladder cancer.
|Bladder Cancer||Drug: mitomycin C Procedure: conventional surgery||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Chemoresection With 4 Weekly Intravesical Instillations Of Mitomycin C Versus Transurethral Resection (TUR) Followed By One Single Immediate Instillation Of Mitomycin C In Single, Small, Papillary Stage Ta, T1 Bladder Tumors: A Prospective Randomized Phase III Trial|
|Study Start Date:||May 2002|
|Primary Completion Date:||May 2004 (Final data collection date for primary outcome measure)|
- Compare the efficacy of chemoresection with 4 weekly intravesical instillations of mitomycin vs transurethral resection followed by 1 instillation of mitomycin in patients with low-risk superficial transitional cell carcinoma of the bladder.
- Compare the disease-free survival of patients treated with these regimens.
- Determine the response rate at 6 weeks in patients treated with chemoresection.
- Determine the percent of patients with tumor at 6 weeks treated with transurethral resection.
- Compare the quality of life of patients treated with these regimens.
- Compare the side effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (primary vs recurrent) and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo chemoresection with intravesical instillation of mitomycin once weekly for 4 weeks.
- Arm II: Patients undergo transurethral resection followed within 1-6 hours by intravesical instillation of mitomycin.
Quality of life is assessed at baseline, at week 1 (arm II only), at week 5 (arm I only), and then at week 6.
Patients are followed at weeks 6 and 19, every 6 months for 3 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 1,000 patients (500 per treatment arm) will be accrued for this study within 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042887
|Academisch Ziekenhuis der Vrije Universiteit Brussel|
|Brussels, Belgium, 1090|
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|Virga Jesse Hospital|
|Hasselt, Belgium, 3500|
|Leuven, Belgium, B-3000|
|Universita Di Palermo|
|Palermo, Italy, 90141|
|Ospedale S.S. Annunziata|
|Savigliano, Italy, 12038|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Netherlands, 1091 HA|
|Academisch Medisch Centrum|
|Amsterdam, Netherlands, 1105 AZ|
|Jeroen Bosch Ziekenhuis|
|NL'S Hertogenbosch, Netherlands, NL-5211|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|Comenius University School of Medicine|
|Martin, Slovakia, 03659|
|Dokuz Eylul University School of Medicine|
|Izmir, Turkey, 35340|
|Study Chair:||Willem Oosterlinck, MD, PhD||Universitair Ziekenhuis Gent|