A Prospective, Randomized, Open-Label, Phase II Trial Comparing Sequential Intravesical Gemcitabine Plus Docetaxel With Sequential Intravesical Gemcitabine Plus Mitomycin C in Patients With BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- 12-Month Event-Free Survival
研究概览
简要总结
This prospective, randomized, open-label, phase II clinical trial compares two sequential intravesical chemotherapy regimens in patients with bacillus Calmette-Guérin (BCG)-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC) following complete transurethral resection of bladder tumor (TURBT). Participants are randomized in a 1:1 ratio to receive sequential intravesical gemcitabine plus docetaxel or sequential intravesical gemcitabine plus mitomycin C. The primary objective is to compare 12-month event-free survival between treatment groups. Secondary objectives include evaluation of cystectomy-free survival, progression-free survival, treatment safety, tolerability, and patient-reported quality of life.
详细描述
High-grade BCG-unresponsive non-muscle-invasive bladder cancer remains a major therapeutic challenge. Radical cystectomy is considered the standard treatment; however, many patients are unwilling or medically unfit to undergo surgery. Sequential intravesical chemotherapy has emerged as a bladder-preserving treatment strategy with encouraging oncological outcomes.
This prospective, randomized, open-label, single-center phase II trial is designed to compare the efficacy and safety of two sequential intravesical chemotherapy regimens following complete TURBT.
Eligible patients with histologically confirmed BCG-unresponsive high-grade NMIBC will be randomized in a 1:1 ratio to receive either sequential intravesical gemcitabine followed by docetaxel or sequential intravesical gemcitabine followed by mitomycin C.
Both treatment regimens consist of a six-week induction course followed by monthly maintenance instillations for twelve months according to the study protocol. Clinical follow-up includes cystoscopy, urine cytology, pelvic ultrasonography, adverse event assessment according to CTCAE criteria, and quality-of-life evaluation using the EORTC QLQ-C30 and EORTC QLQ-NMIBC24 questionnaires.
The primary endpoint is 12-month event-free survival. Secondary endpoints include cystectomy-free survival, progression-free survival, safety, tolerability, and comparative efficacy of both treatment strategies.
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
盲法说明
This is an open-label study because both treatment regimens are administered according to predefined clinical protocols and blinding is not feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Histologically confirmed BCG-unresponsive non-muscle-invasive urothelial bladder cancer (NMIBC).
- •Complete transurethral resection of bladder tumor (TURBT) before study treatment.
- •Intermediate- or high-risk NMIBC according to current clinical guidelines.
- •Candidate for intravesical chemotherapy.
- •ECOG performance status 0-
- •Adequate hematologic, renal, and hepatic function.
- •Written informed consent.
排除标准
- •Muscle-invasive (≥T2), locally advanced, or metastatic urothelial carcinoma.
- •Upper urinary tract urothelial carcinoma requiring treatment.
- •Previous hypersensitivity to gemcitabine, docetaxel, mitomycin C, or formulation components.
- •Active uncontrolled urinary tract infection.
- •Pregnancy or breastfeeding.
- •Concurrent participation in another interventional clinical trial.
- •Any serious uncontrolled medical condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.
研究组 & 干预措施
Sequential Gemcitabine + Mitomycin C
Participants receive sequential intravesical gemcitabine followed by mitomycin C after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months.
干预措施: Gemcitabin (Drug)
Sequential Gemcitabine + Mitomycin C
Participants receive sequential intravesical gemcitabine followed by mitomycin C after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months.
干预措施: Mitomicin C (Drug)
Sequential Gemcitabine + Docetaxel
Participants receive sequential intravesical gemcitabine followed by docetaxel after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months.
干预措施: Gemcitabin (Drug)
Sequential Gemcitabine + Docetaxel
Participants receive sequential intravesical gemcitabine followed by docetaxel after complete TURBT. Treatment consists of six weekly induction instillations followed by monthly maintenance instillations for 12 months.
干预措施: Docetaxel (Drug)
结局指标
主要结局
12-Month Event-Free Survival
时间窗: 12 months after randomization
Event-free survival is defined as the time from randomization to the first occurrence of histologically confirmed recurrence, disease progression to muscle-invasive bladder cancer, radical cystectomy, distant metastasis, or death from any cause.
次要结局
- Progression-Free Survival(Up to 12 months)
- Cystectomy-Free Survival(Up to 12 months)
- Treatment-Related Adverse Events(Throughout study treatment and follow-up)
- Health-Related Quality of Life (EORTC QLQ-C30)(Baseline through 12 months)
- Health-Related Quality of Life (EORTC QLQ-NMIBC24)(Baseline through 12 months)