Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer
18 Years
74 Years
Both
Bladder Cancer
Trial Information
Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer
OBJECTIVES:
- Compare the overall, cause-specific, and disease-free survival of patients with
high-risk muscle-invasive transitional cell carcinoma of the bladder treated with
adjuvant cisplatin and gemcitabine vs observation after radical cystectomy.
- Compare the dose intensity and toxicity of two different schedules of cisplatin and
gemcitabine in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and disease status (T2 [G3 only] or T3-4 [any G], N0-2 vs any T, N1-2,
M0). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients are further randomized to 1 of 2 treatment regimens.
- Regimen A: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8,
and 15.
- Regimen B: Patients receive cisplatin IV on day 15 and gemcitabine as in regimen
A.
Treatment in both regimens repeats every 28 days for 4 courses.
- Arm II: Patients undergo observation followed by cisplatin and gemcitabine as in arm I
at relapse.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this
study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed transitional cell carcinoma of the bladder
- T2 (G3 only) or T3-4 (any G), N0-2 or any T, N1-2, M0
- No secondary localization
- Radical cystectomy (without residual disease) performed within 10 weeks prior to
study entry to include:
- Men: Cystectomy with removal of prostate and seminal vesicles including 1.5 cm
of urethra plus pelvic lymphadenectomy (at least 15 negative lymph nodes are
recommended to define as N0)
- Women: Cystectomy with complete removal of the bladder, uterus, ovaries, and
anterior walls of the vagina plus pelvic lymphadenectomy
PATIENT CHARACTERISTICS:
Age
- 18 to 74
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,500/mm^3
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin less than upper normal limit (ULN)
- Gamma-GT less than ULN
- SGOT and SGPT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal
- Creatinine no greater than1.25 times ULN
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No congestive heart failure
- No angina pectoris
- No cardiac arrhythmia
- No uncontrolled arterial hypertension
- No history of acute myocardial infarction within the past year
Other
- No other serious concurrent illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Palliative radiotherapy allowed at relapse for symptomatic bone metastases
Surgery
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Overall survival at 5 years
Safety Issue:
No
Principal Investigator
Camillo F. Pollera, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Presidio Ospedaliero Belcolle
Authority:
United States: Federal Government
Study ID:
CDR0000258426
NCT ID:
NCT00054626
Start Date:
September 2001
Completion Date:
Related Keywords:
- Bladder Cancer
- stage II bladder cancer
- stage III bladder cancer
- stage IV bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
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