Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients With pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 285
- 主要终点
- Duration of survival
研究概览
简要总结
Randomized phase III trial to compare the effectiveness of immediate adjuvant chemotherapy with that of adjuvant chemotherapy given when the cancer returns in treating patients who have undergone a radical cystectomy for stage III or stage IV transitional cell carcinoma of the bladder urothelium. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known if adjuvant chemotherapy is more effective when given immediately after radical cystectomy (surgery to remove the bladder) or when the cancer returns.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm I (immediate chemotherapy)
Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
干预措施: doxorubicin hydrochloride (Drug)
Arm I (immediate chemotherapy)
Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
干预措施: gemcitabine hydrochloride (Drug)
Arm I (immediate chemotherapy)
Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
干预措施: vinblastine sulfate (Drug)
Arm I (immediate chemotherapy)
Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
干预措施: methotrexate (Drug)
Arm I (immediate chemotherapy)
Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
干预措施: cisplatin (Drug)
Arm I (immediate chemotherapy)
Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
干预措施: filgrastim (Biological)
Arm II (deferred chemotherapy)
Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
干预措施: doxorubicin hydrochloride (Drug)
Arm II (deferred chemotherapy)
Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
干预措施: gemcitabine hydrochloride (Drug)
Arm II (deferred chemotherapy)
Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
干预措施: vinblastine sulfate (Drug)
Arm II (deferred chemotherapy)
Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
干预措施: methotrexate (Drug)
Arm II (deferred chemotherapy)
Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
干预措施: cisplatin (Drug)
Arm II (deferred chemotherapy)
Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
干预措施: filgrastim (Biological)
结局指标
主要结局
Duration of survival
时间窗: 5 years
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.
Duration of progression-free survival
时间窗: 5 years
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.
次要结局
未报告次要终点