A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 69
- 试验地点
- 24
- 主要终点
- Disease-free Survival
研究概览
简要总结
If radical cystectomy remains the standard of care for muscle invasive bladder cancer, consequences of this surgical procedure are often harsh. Over the past years, concurrent chemo-radiotherapy has imposed itself as an alternative treatment. Published data on concomitant radiochemotherapy (radiotherapy/cisplatin or radiotherapy/cisplatin/5-fluorouracil combinations) showed local control rates with bladder preservation at 5 years ranging from 40% to 65% according to the disease stage, and overall survival probabilities ranging from 40% to 50% at 5 years. In order to improve local and systemic prognosis, evaluation of other chemotherapy agents with higher radiosensitizing effect, such as gemcitabine, is justified. Gemcitabine possesses its own anti-cancer activities on urothelial diseases and has a synergetic activity with cisplatin. The investigators completed a monocenter phase I study combining radiotherapy, cisplatin, and twice-weekly gemcitabine, and determined a recommended dose of gemcitabine 25 mg/m². The objective of the present study is to evaluate the combination of radiotherapy + cisplatin + gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial cancer patients.
详细描述
The objective of the present study is to evaluate the combination of radiotherapy + cisplatin + gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial cancer patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Muscle invasive urothelial cancer (front line or following the progression of a superficial tumor), pT2-pT3 stage without lymphatic impairment (N0) and without detectable metastases (M0). An optimal macroscopic resection (TURB) have to be performed
- •The proof of invasive tumor to the muscle should be brought by a transurethral resection under anaesthesia less than 8 weeks before or, in the absence, by superficial biopsies and formal imaging. Multiples biopsies in the bladder must also be performed.
- •Age ≥ 18 years
- •Life expectancy ≥ 6 months
- •Kanorfsky index ≥ 70 % (WHO 0, 1, 2)
- •Biological criteria: neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3, haemoglobin ≥ 10 g/dl, creatinine clearance > 60 ml/mn
- •No distant metastases (Thorax, abdomen, and pelvic CT-scan, bone scan)
- •Efficient contraception for premenopausal women, maintained during the whole treatment and up to two months after the completion of radiotherapy.
- •No radiotherapy or chemotherapy history except for in situ bladder lesions.
- •No carcinological history except for non melanoma skin tumours, in situ uterine cervix cancer
- •No contraindication to gemcitabine or cisplatin.
- •No contraindication to radiotherapy
- •Information letter and informed consent signed
- •Patient covered by social security
排除标准
- •Bladder tumors without any muscle infiltration
- •Epidermoid carcinoma or adenocarcinoma
- •Distance metastases or extrapelvic node positivity
- •Severe digestive history (ulcerative colitis, complicated diverticulitis)
- •Pregnancy and breast feeding
结局指标
主要结局
Disease-free Survival
时间窗: Two years after the end of the complete therapeutic sequence
The time to relapse is defined as the time from the date of randomisation to the date of the first event. Time to relapse for patients without any event (local, regional, distance, or death) will be censored at the date of latest information. Patients without relapse and living at 2 years will be considered a success
次要结局
- Overall Survival(Up to 5 years)
- Acute and Late Toxicities(Up to 5 years)
- Correlation Between Lymphocyte Apoptosis and Severity of Late Toxicities.(Up to 5 years)