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
N/A
N/A
Both
Stage III Bladder Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder
Trial Information
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
PRIMARY OBJECTIVES:
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
adjuvant chemotherapy.
Patients in both arms receive one of the following chemotherapy regimens to be determined by
participating center:
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
annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Inclusion Criteria:
- Histologically confirmed transitional cell carcinoma of the bladder urothelium
- T3-4, N1-3, M0
- No pure squamous cell or adenocarcinoma tumors
- No more than 90 days since prior radical cystectomy and bilateral lymphadenectomy
without evidence of microscopic residual disease
- Performance status - WHO 0-1
- WBC at least 3,500/mm^3
- Platelet count at least 120,000/mm^3
- SGOT/SGPT less than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase less than 2.5 times ULN
- Bilirubin normal
- Glomerular filtration rate greater than 60 mL/min
- No clinically significant cardiac arrhythmia
- No congestive heart failure
- No complete bundle branch block
- No New York Heart Association class III or IV heart disease
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after study
- Considered fit for cisplatin-containing combination chemotherapy
- No clinically abnormal auditory function
- No known hypersensitivity to E. coli-derived drug preparations
- No grade 2 or greater peripheral neuropathy
- No other prior or concurrent malignancy except adequately treated carcinoma in situ
of the cervix, treated basal cell skin cancer, or treated incidental prostate cancer
(pT2, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)
- No psychological, familial, sociological, or geographical condition that would
preclude study involvement
- No prior systemic chemotherapy
- No prior radiotherapy to the bladder
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Duration of survival
Outcome Description:
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.
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Mitchell Benson
Investigator Role:
Principal Investigator
Investigator Affiliation:
Southwest Oncology Group
Authority:
United States: Institutional Review Board
Study ID:
NCI-2011-02060
NCT ID:
NCT00028756
Start Date:
October 2001
Completion Date:
Related Keywords:
- Stage III Bladder Cancer
- Stage IV Bladder Cancer
- Transitional Cell Carcinoma of the Bladder
- Urinary Bladder Neoplasms
- Carcinoma
- Carcinoma, Transitional Cell
Name | Location |
|---|---|
| Southwest Oncology Group (SWOG) Research Base | San Antonio, Texas 78245 |
