Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT00042887
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Virga Jesse Hospital
🇧🇪Hasselt, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Comenius University School of Medicine
🇸🇰Martin, Slovakia
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Universita Di Palermo
🇮🇹Palermo, Italy
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Jeroen Bosch Ziekenhuis
🇳🇱NL'S Hertogenbosch, Netherlands
Ospedale S.S. Annunziata
🇮🇹Savigliano, Italy
Daniel Den Hoed Cancer Center at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Dokuz Eylul University School of Medicine
🇹🇷Izmir, Turkey