Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer: an Open-label, Randomised Phase 3 Trial.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- median overall survival
研究概览
简要总结
There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus 5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to 40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with cisplatin is evaluated by median survival time, progression free survival,and response rate.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic esophageal tumors with no previous treatment for advanced disease or recurrent disease after previous treatment for at least one year.
- •At least one measurable lesion according to the RECIST1.1 (Response Evaluation Criteria in Solid Tumors RECIST Version 1.1) criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques.
- •Patients aged between 18 and 70 years, inclusive, at the time of acquisition of informed consent
- •Patients with performance status(ECOG) 0 to
- •Abnormal hematologic values (WBC ≥ 3.0 x 109/L, Hemoglobin ≥ 10.0g/dl, platelet count ≥ 100 x 109/L)
- •Creatinine clearance ≥ 60 ml/min, Serum creatinine ≤ 1.5mg/dl
- •Serum bilirubin ≤ 1.5mg/dl. ALT(Alanine transaminase ), AST(Aspartate Transaminase) ≤ 2.5 x upper normal limit (or ≤ 2.5 x upper normal limit in the case of liver metastases)
- •Life expectancy ≥ 3 months
- •Patients who have given written informed consent to participate in this study
排除标准
- •Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer)
- •Serious, uncontrolled, concurrent infection(s) or illness(es)
- •Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
- •Patients with brain metastasis
- •Patients receiving continuous administration of steroids
- •Patients who have experienced serious drug allergy in the past
- •Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
- •Patients who are pregnant and lactating or hope to become pregnant during the study period
- •Patients with prior Taxane treatment (Paclitaxel)
- •Others, patients judged by the investigator or coinvestigator to be inappropriate as subject
研究组 & 干预措施
Cisplatin plus 5-fluorouracil
Cisplatin:
37.5 mg/m2, IV (in the vein) on day 1-2 of each 21 day cycle. Number of Cycles: up to 6 cycles.
5-fluorouracil: 200mg/m2, CIV (continuous intravenous infusion) on day 1~5 of each 21 day cycle. Number of Cycles: up to 6 cycles.
干预措施: 5-fluorouracil (Drug)
Paclitaxel liposome and Cisplatin
Drug: paclitaxel liposome 175mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles:up to 6 cycles.
Drug: cisplatin 37.5 mg/m2, IV (in the vein) on day 1~2 of each 21 day cycle. Number of Cycles: up to 6 cycles.
干预措施: Paclitaxel liposome (Drug)
Paclitaxel liposome and Cisplatin
Drug: paclitaxel liposome 175mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles:up to 6 cycles.
Drug: cisplatin 37.5 mg/m2, IV (in the vein) on day 1~2 of each 21 day cycle. Number of Cycles: up to 6 cycles.
干预措施: Cisplatin (Drug)
Cisplatin plus 5-fluorouracil
Cisplatin:
37.5 mg/m2, IV (in the vein) on day 1-2 of each 21 day cycle. Number of Cycles: up to 6 cycles.
5-fluorouracil: 200mg/m2, CIV (continuous intravenous infusion) on day 1~5 of each 21 day cycle. Number of Cycles: up to 6 cycles.
干预措施: Cisplatin (Drug)
结局指标
主要结局
median overall survival
时间窗: one year
次要结局
- median progression free survival(6 months)
研究者
Lin Yingcheng
deputy secretary
Shantou University Medical College