A Multicenter Randomized Phase II Study to Evaluate the Benefit of Chemotherapy Plus Best Supportive Care (BSC) Versus BSC in Patients With Metastatic Oesophageal Cancer of Squamous Cell-type Who Have Not Experienced a Disease Progression or Unacceptable Toxicity After a 6-weeks Chemotherapy Course .
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 105
- 试验地点
- 17
- 主要终点
- Overall survival
研究概览
简要总结
Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type
The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.
详细描述
As the data in litterature does not provide the basis for well-argued statistical hypothesis, it is suggested to randomize 30 patients per arm. An IDMC will come to a decision after the inclusion of 10, 20 ans 40 patients on the efficacy and the toxicity profile and on whether to maintain the current clinical position, justifying randomisation . In order to take into account any possible effects of prior concomitant radiochemotherapy, patient will be stratified according to whether they have already undergone chemotherapy or radiochemotherapy.
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
- •Patients with an histologically proven epidermoid cancer of the oesophagus
- •Patients with metastatic disease that can be measured or evaluated according to the RECIST criteria, and located outside of previously irradiated fields
- •Patients who may or may not have undergone radiochemotherapy
- •Patients who have not received chemotherapy for metastatic disease
- •Performance Status (ECOG) ≤ 2
- •People who are covered by private or state health insurance
- •Informed consent signed by the patient
排除标准
- •Other evolutive malignant tumor
- •Infection with HIV-1, HIV-2 or chronic hepatitis B or C
- •Cerebral metastasis or known meningeal tumor
- •Any unstable chronic diseases that could risk the safety or the compliance of te patient
- •Women who are pregnant or breastfeeding. Women must not breastfeed for at least 6 months after administration of Bevacizumab
- •Patients unable to undergo the follow-up of the trial for geographical, social or psychological reasons
- •For the randomized part
- •Inclusion criteria :
- •Non-progressive disease after the 6 first weeks of chemotherapy
- •Performance Status (ECOG) ≤ 2
研究组 & 干预措施
Chemotherapy plus best supportive care
Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
干预措施: FU-CDDP (Drug)
Chemotherapy plus best supportive care
Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
干预措施: LV5FU2-CDDP (Drug)
Chemotherapy plus best supportive care
Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
干预措施: FOLFOX (Drug)
Chemotherapy plus best supportive care
Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
干预措施: TPF (Drug)
Best supportive care
Best supportive care with follow up every 6 weeks
干预措施: Best Supportive Care (Other)
结局指标
主要结局
Overall survival
时间窗: Between the date of randomisation and the date of death
次要结局
- Progression free survival(Between the date of randomisation and the date of progression)
- Tolerance(At each visit : every 6 weeks)
- Quality of life by QLQ-C30(Every 6 weeks)
- Cost analysis(Every 6 weeks)