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
- 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
- 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
PROJECTED ACCRUAL: A total of 1,000 patients (500 per treatment arm) will be accrued for
this study within 5 years.
Allocation: Randomized, Primary Purpose: Treatment
Willem Oosterlinck, MD, PhD
Universitair Ziekenhuis Gent
United States: Federal Government