A Phase II Feasibility Study of Combined Accelerated External Radiation and Chemotherapy With 5FU and CDDP Following Transurethral Resection in Patients With Muscle Invasive Transitional Carcinoma of the Bladder - T2-T3, N0, M0 (UICC 1992)
OBJECTIVES: I. Evaluate the rate of severe acute toxicity occurring during therapy with
accelerated external radiotherapy with concurrent fluorouracil (5-FU) and cisplatin
following transurethral resection of the bladder in patients with stage II or III muscle
invasive transitional cell carcinoma of the bladder. II. Evaluate the rate of freedom from
local recurrence to this combined therapy assessed 3 months after the end of treatment in
these patients. III. Assess the feasibility of this new therapeutic approach in this patient
population. IV. Determine the overall recurrent free survival, long term side effects, and
overall survival in these patients.
OUTLINE: This is an open label, multicenter study. Patients undergo accelerated external
radiotherapy twice daily 5 days a week for 5 weeks. Concurrent chemotherapy is administered
on the first and fifth week consisting of cisplatin IV over 2 hours daily and fluorouracil
by 24 hour continuous infusion daily on days 1-5. Patients are followed at 3 months, then
every 3 months for the first 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: There will be 19-43 patients accrued into this study.
Primary Purpose: Treatment
Michel Bolla, MD
CHU de Grenoble - Hopital de la Tronche
United States: Federal Government