A Phase II Study of Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in esophageal cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 18 -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
Chemoradiotherapy Arm
Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy. Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy.
干预措施: Endostatins (Drug)
Chemoradiotherapy Arm
Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy. Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy.
干预措施: Oxaliplatin (Drug)
Chemoradiotherapy Arm
Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy. Oxaliplatin (135mg/m², d1) will be administered on Day 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 3-4
Response rate will be done after 3-4 weeks following the last radiotherapy session.
次要结局
- Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)(year 0 - year 3)
- Progression-free survival(year 0 - year 3)
- Overall survival(year 0 - year 3)
研究者
Shixiu Wu
MD
Hangzhou Cancer Hospital