2X2 Factorial Randomized Phase III Study Comparing Standard Versus Reduced Volume Radiotherapy With and Without Synchronous Chemotherapy in Muscle Invasive Bladder Cancer
- Compare the efficacy of standard volume radiotherapy vs reduced volume radiotherapy
with or without synchronous fluorouracil and mitomycin in patients with stage II or III
(muscle invasive) bladder cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, prior neoadjuvant chemotherapy (yes vs no), and intent to enter only 1
of the possible 2 randomizations on study (yes vs no). Patients are randomized to one of two
- Arm I: Patients undergo standard radiotherapy once daily 5 days a week for 4 or 6.5
weeks. Patients also receive synchronous chemotherapy comprising mitomycin IV on day 1
and fluorouracil IV continuously over days 1-5 and 16-20 during radiotherapy.
- Arm II: Patients undergo standard radiotherapy as in arm I (without chemotherapy).
If standard radiotherapy is clearly indicated (e.g., patients with multiple tumors) patients
may be randomized to standard radiotherapy with or without chemotherapy (arms I or III
above). If chemotherapy is clearly contraindicated, patients are randomized to standard or
reduced volume radiotherapy without chemotherapy (arms III or IV above).
Quality of life is assessed at baseline, at the end of therapy, at 6 and 12 months
post-randomization, and then annually for at least 5 years.
Patients are followed at 6, 9, and 12 months post-randomization and then at least annually
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Loco-regional disease free survival at 2 years
Nicholas D. James, MD
University Hospital Birmingham
United States: Federal Government