NCT03301454终止2 期
Phase II Randomized Study Measuring the Interest of Pursuing or Not the CT for Non-progressive Patients With Metastatic Esophageal Squamous-cell Cancer After 6 Weeks of LV5FU2-paclitaxel Given After a 1st Line Fluoropyrimidine/Pt Salt CT
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Estimate the overall survival for patients suffering from Esophageal cancer
研究概览
简要总结
Phase II study, randomized, open-label, multicentric, willing to establish the benefit of pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in two successive phases :
- non randomized phase in which all patients will undergo chemotherapy
- second phase in which only non progressive patients are going to be randomized ("discontinuation design"). Patients that will show progression in their disease during the first 6 weeks will be released of the study
详细描述
Initial phase: this part of the trial consist of 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - 5-FU continuously during 46h: 3000 mg/m², calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² at day 1) every 14 days. After 6 weeks,the phase will end with a check-up (clinical exam, tumor evaluation and biological test). Then, if the disease is non-progressive, the patient will proceed to the randomized phase.
Randomized phase:
- Arm A : pursuit of chemotherapy and best supportive care
- Arm B : interruption of chemotherapy and best supportive care
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 suffering from squamous-cell type esophageal cancer histologically proved
- •Metastatic disease measurable according to RECIST criteria. Patients with metachronous metastasis and who have been treated with surgery (+/- radio chemotherapy concurrent or adjuvant chemotherapy) or exclusive radio chemotherapy, are eligible
- •Patients who show progress under chemotherapy that associates a fluoropyrimidine with a platinum salt
- •Man or woman over 18 years old
- •ECOG performance status ≤ 2
- •Adequate haematological, renal and hepatic functions : PNN ≥ 1500/ mm3; platelets ≥ 100 000/ mm3; Haemoglobin ≥ 9.0 g/dL; ALT and AST ≤ 2.5 ULN (≤ 5.0 in case of liver metastases); Total bilirubin ≤ 1.5 X ULN; Serum creatinine ≤ 1.5 ULN
- •Efficient contraceptive method for both gender (if applicable), during the whole treatment period and the 6 months following the last treatment administration
- •Affiliation to the National Social Security System
- •With informed and signed consent
- •Inclusion Criteria for randomization:
- •ECOG performance status ≤ 2
- •Able to pursuit the LV5FU2-paclitaxel chemotherapy
- •Non-progressive disease after the initial phase (first tumor exam at week 6)
排除标准
- •Patients who received more than one line of chemotherapy for a metastatic disease
- •Presence of other evolutive tumors
- •Cerebral metastasis or other known brain tumors
- •Severe liver failure
- •Pernicious anemia or other anemia due to vitamin B12 defficiency
- •Hypersensibility to an active substance or any other excipients of experimental drugs
- •Every unstable chronicle diseases that can affect patient confidence or security
- •Clinically significant active cardiac disease or myocardial infarction in the 6 previous months
- •Patients with a known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Concomitant treatment with : sorivudin or analogs; prophylactic phenytoin
- •Live attenuated vaccine within the 3 previous months
- •Pregnant or breastfeeding women
- •Unable to comply with the medical monitoring for geographic, social or mental issues
- •Patient Under guardianship or tutorship
研究组 & 干预措施
Arm A
Experimental
Pursuit of chemotherapy.
干预措施: pursuit of chemotherapy (Drug)
Arm B
No Intervention
Interruption of chemotherapy, best supportive care
结局指标
主要结局
Estimate the overall survival for patients suffering from Esophageal cancer
时间窗: From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
Non-progressive disease at and after 6 weeks of treatment until progression
次要结局
- Estimate efficiency in term of overall survival, of pursuing chemotherapy(From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment)
- Estimate the efficiency in term of progression-free of pursuing chemotherapy(From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment)
- Estimate the overall survival of the whole study population(From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment)
- Measure the toxicity of chemotherapy(from baseline up to 12 months)
- Estimate the consequences of pursuing chemotherapy(From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment)
- Estimate the rate of non progressive patients(From date of inclusion until the date of the end the 6 firsts weeks of treatment)
研究者
研究点 (5)
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