Long-term Results of Definitive Concurrent Chemoradiotherapy Using Paclitaxel Plus Oxaliplatin in Unresectable Locally Advanced Esophageal Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 主要终点
- response rate
研究概览
简要总结
This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologically or histologically confirmed esophageal carcinoma
- •Age of 20 -80
- •ECOG performance status: 0-1;
- •No treatments prior to enrollment;
- •At least one measurable lesion on CT, MRI or esophageal barium exam;
- •Normal functions of heart, lung, liver, kidney and bone marrow
- •Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
- •Informed consent signed
排除标准
- •Prior treatments of chemotherapy or irradiation;
- •Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
- •Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
- •Participating in other clinical trials;
- •Pregnancy, breast feeding, or not adopting birth control;
- •Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
- •The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
研究组 & 干预措施
Concurrent Chemoradiotherapy Arm
Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.
干预措施: Paclitaxel (Drug)
Concurrent Chemoradiotherapy Arm
Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.
干预措施: Oxaliplatin (Drug)
Concurrent Chemoradiotherapy Arm
Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
response rate
时间窗: week 4
Response rate was done after 4 weeks following the last radiotherapy session.
次要结局
- Survival outcome(year 0- year 5)
- Toxicity(year 0- year 5)
研究者
Shixiu Wu
MD
Hangzhou Cancer Hospital