Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas - A Prospective, Multicentric and Randomized Study.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 36
- 主要终点
- Patients' survival compared between both groups : PDT and non-PDT.
研究概览
简要总结
Unresectable type III or IV cholangiocarcinoma has a very bad prognosis; survival median ranges between 6 and 9 months.
Survival depends on biliary drainage quality, obtained by plastic or metallic prothesis setting up in one or several hepatic segments.
Radiotherapy and/or chemotherapy didn't prove yet their efficiency on survival. In France, gemcitabin is recommended by the French Digestive Oncology Federation in metastatic tumours, in monotherapy or associated with cisplatin or oxaliplatin (Gemox) for patients in good general condition.
Photodynamic therapy has shown in 3 prospective studies - one randomized - with small patient series, a significative efficiency on survival and quality of life of treated patients, in comparison with historical series, or patients' groups whose biliary drainage was in most cases unefficient.
A new randomized study, including patients whose biliary drainage is efficient and comparing their becoming when they are treated by PDT in addition to current practice, or only by current practice, seems to be justified.
The principal objective of this study is to evaluate the efficiency of PDT with Photofrin® on patients with unresectable type III or IV cholangiocarcinoma.
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
- •Obtention of a written informed consent.
- •Patient over
- •Patient with a type III or IV (according to Bismuth classification) histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under scope control with pediatric pliers, or by cytologic puncture under scan or echoendscopic control.
- •Patient with Karnofsky score ≥ 50 %
- •Patient with an efficient initial biliary drainage with prothesis.
- •Cancer classified maximum T3N1M1, but only with intrahepatic metastasis occupying less than 25% of hepatic parenchyme (according to TNM cancer classification of extrahepatic biliary ducts' cancers).
- •Patient capable of fill in the quality of life questionnaire.
排除标准
- •No written informed consent.
- •Type I and II cholangiocarcinoma according to Bismuth classification.
- •Patients with ASA score
- •Patients with clinical and biological signs of biliary infection.
- •Patients with a severe visceral disease other than cholangiocarcinoma.
- •Patients without an efficient initial biliary drainage.
- •Patients with extrahepatic visceral metastasis, except perihilar ganglionic metastasis classified T4N1M+ according to TNM classification.
- •Patients whose cholangiocarcinoma has already been resected.
- •Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
- •Patients first treated with metallic prothesis.
- •Patients with a contraindication to MRI.
- •Patients with porphyria or hypersensibility to porphyrins.
- •Patient treated by a non authorized treatment at the time of inclusion.
- •Pregnant, parturient or breastfeeding women.
- •Non menopaused woman without an efficient contraception.
- •Patient under
- •Person over 18 under protection according to French Public Health Code.
- •Person not affiliated to a social security regimen, or benefiting from such a regimen.
- •Person in a exclusion period of another biomedical study.
结局指标
主要结局
Patients' survival compared between both groups : PDT and non-PDT.
次要结局
未报告次要终点