Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 700
- 试验地点
- 294
- 主要终点
- Overall survival at 5 years
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is effective in preventing relapse in patients who have undergone radical cystectomy for bladder cancer.
PURPOSE: Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine with that of observation in treating patients with bladder cancer who have undergone surgery to remove the bladder.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status
- •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
- •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
- •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
- •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
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Overall survival at 5 years
次要结局
- Disease-free survival at 5 years
- Local disease-free survival at 5 years
- Distant disease-free survival at 5 years
- Quality of life after each course and every 6 months during follow-up
- Toxicity by WHO system grading after each course
- Dose intensity at the end of the treatment