A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Progression-Free-Survival
研究概览
简要总结
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
详细描述
108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival, toxicity of the therapy are other second endpoint.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)
- •Measurable disease according to RECIST criteria
- •Age > 18 years
- •WHO performance score < 2
- •Estimated life expectancy of > 12 weeks
- •Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
- •Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
- •Renal function: Cr ≤ 1.25×UNL
- •Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
- •Documented informed consent to participate in the trial
排除标准
- •Subjects with distant metastases
- •Pregnancy or breast feeding. Women of childbearing age must use effective contraception
- •Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- •Evidence of bleeding diathesis or serious infection
- •pregnant or lactating woman
- •Patient participation in other studies
研究组 & 干预措施
Radiotherapy
Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
干预措施: Radiotherapy (Radiation)
Raltitrexed/Oxaliplatin Plus Radiotherapy
Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
干预措施: Raltitrexed (Drug)
Raltitrexed/Oxaliplatin Plus Radiotherapy
Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
干预措施: Oxaliplatin (Drug)
Raltitrexed/Oxaliplatin Plus Radiotherapy
Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression-Free-Survival
时间窗: up to 2 years
Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.
次要结局
- Response Rate(up to 2 years)