Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients with Locally Advanced Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- recurrence free survival rate
研究概览
简要总结
Effect of adjuvant intra-arterial chemotherapy to control tumor progression in patients cystectomized for locally advanced bladder cancer.
详细描述
For locally advanced bladder cancer patients, tumor relapse rates after radial cystectomy were even as high as 50%-62%.Five-year disease-specific survival and OS rates in the organ-confined disease (defined as ≤pT3a) were 78.9% and 68%, respectively. For the non-organ-confined disease (defined as pT3b or higher), the rates were about 36.8% and 30.3%, respectively.Systemic chemotherapy can only prolong survival for up to 14.8 months, although with multiple severe adverse effects, such as neutrocytopenia, infection/sepsis, renal dysfunction, mucositis, or gastrointestinal toxicity. Additionally, the mortality rate associated with systemic chemotherapy was about 1%-4%.Therefore, the objective of our study was to determine if adjuvant intra-arterial chemotherapy with GC was able to reduce the systemic drug toxicities and yield a better clinical outcome.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy.
- •Transitional cell carcinoma of bladder, stage pT3-4,N1-3,M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.
- •Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
- •ECOG performance status 0 or
- •Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase[SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normal (ULN).Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).
- •Absolute neutrophil count (ANC) ≥ 1500/μL
- •Platelets ≥ 75,000/μL
- •Hemoglobin ≥ 8.0 g/dL
- •White blood cell count ≥ 3500/μL
- •Creatinine clearance rate,Ccr ≥ 40ml/min
- •Cardiac function level 0~
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.
排除标准
- •Bladder cancer without any transitional cell carcinoma component,such as adenocarcinoma,squamous cell carcinoma,small cell carcinoma
- •Evidence of distant metastasis beyond the pelvis.
- •No definitely pathological stage,such as no pathologic examination of perivesical fat,unable to differentiate pT2 and pT3,not performing lymph node dissection or regional lymph nodes cannot be assessed as the dissected lymph node number is less than ten.
- •Prior neoadjuvant chemotherapy (systemic or intra-arterial) three months preoperatively, not including intra-vesical infusion chemotherapy.
- •Prior pelvic radiation therapy dosage ≥ 30Gy six months preoperatively.
- •Serious liver and kidney dysfunction.
- •Accompanied with other serious diseases.
- •Severe/unstable angina, arrhythmia,symptomatic heart failure, hypertension that cannot be controlled by medications and 6 months for myocardial infarction.
- •Non-compliance of regular follow-up due to psychological, social, family and geographical and other reasons.
研究组 & 干预措施
Intraaterial chemotherapy
This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm study.Patients with locally advanced TCC of the bladder are randomized to 1 of 2 treatment arms
Arm 1 (treatment):'Surgery of percutaneous catheter system for arterial chemotherapy is done in the Department of Invasive Technology. All medications were administered using percutaneous catheter system via a modified Seldinger technique.Gemcitabine 800 mg/m2 intra-arterial,cisplatin 25 mg/m2 intra-arterial once a week for 3 weeks followed by 1-week rest period. Maximum of 3 cycles. Treatment begins between 1-5 weeks after radical operation (within 40 days is recommended).
干预措施: Surgery of percutaneous catheter system (Procedure)
Watchful waiting
Arm 2 (control): No immediate post-surgery treatment. Patients undergo observation followed by cisplatin and gemcitabine as in arm I at local relapse, or receive intravenously chemotherapy with cisplatin and gemcitabine at multiple metastases
结局指标
主要结局
recurrence free survival rate
时间窗: 60 months
次要结局
- Cancer specific survival(60 months)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(12 months)
- overall survival(60 months)
研究者
ZHOU FANGJIAN
Chair of Urology
Sun Yat-sen University