Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients With pT3-pT4, and/or N+MO Transitional Cell Carcinoma (TCC) of the Bladder
I. Compare the overall and progression-free survival of patients with stage III or IV
transitional cell carcinoma of the bladder urothelium treated with immediate versus deferred
adjuvant chemotherapy after radical cystectomy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, tumor status (pT1-2 vs pT3 vs pT4), and node status (node positive vs
node negative with 15 or more nodes sampled vs node negative with less than 15 nodes
sampled). Patients are randomized to one of two treatment arms.
ARM I: Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses
of adjuvant chemotherapy.
ARM II: Beginning at the time of clinical relapse, patients receive a total of 6 courses of
Patients in both arms receive one of the following chemotherapy regimens to be determined by
REGIMEN A (Classical M-VAC): Patients receive classical M-VAC comprising methotrexate IV on
days 1, 15 and 22; vinblastine IV on days 2, 15, and 22; and doxorubicin IV and cisplatin IV
on day 2. Courses repeat every 28 days.
REGIMEN B (High-dose M-VAC): Patients receive high-dose M-VAC comprising methotrexate IV on
day 1 and vinblastine IV, doxorubicin IV, and cisplatin IV on day 2. Patients also receive
filgrastim (G-CSF subcutaneously once daily on days 4-10. Courses repeat every 14 days.
REGIMEN C (Gemcitabine and cisplatin): Patients receive gemcitabine IV over 30 minutes on
days 1, 8, and 15 followed by cisplatin IV on day 1 or 2. Courses repeat every 28 days.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Duration of survival
Estimated using the Kaplan-Meier technique and compared based on a two sided logrank test with retrospective stratification for the participating cooperative group, the chemotherapy regimen, the T category and the nodal status.
Southwest Oncology Group
United States: Institutional Review Board
|Southwest Oncology Group (SWOG) Research Base||San Antonio, Texas 78245|