Low-dose Aspirin Therapy for Stage II-III Esophageal Cancer- A Multi-Center, Open Label, Randomized Controlled Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Disease-free survival
研究概览
简要总结
The aim of this study is to evaluate the survival benefit of low-dose aspirin use for stage II-III esophageal cancer patients.
详细描述
The investigators aimed to evaluate the hypothesis that low-dose aspirin can improve survival in stage II-III esophageal cancer patients, and to evaluate whether this effect is influenced by PIK3CA, KRAS, BRAF mutation and COX-2 expression. Eligible participants will be randomized to either aspirin treatment arm (100 mg aspirin OD for 3 years), or non-aspirin user arm in 1:1 ratio. After randomization, participants will receive 3 monthly assessments during treatment and follow-up.
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
- •Male or female subjects with an age of 18 years or older.
- •Subjects with Stage II-III histological proven esophageal cancer.
- •Subjects with performance status (PS) of 0-1 or ECOG performance status 0-
- •Subjects must have signed an approved informed consent prior to any study procedures.
- •Subjects with adequate bone marrow, hepatic and renal functions, with a) neutrophils ≥ 1.5x109/ L; platelets ≥ 100x109/L; hemoglobin ≥ 9g/dL; b) Total bilirubin ≤ 2.0 x the upper limit normal; ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastasis); c) creatinine clearance > 50 ml/min;
- •Subjects undergone complete resection of primary tumor;
- •Subjects with life expectancy ≥ 3 months.
- •Completed standard therapy ( at least 3 months of chemotherapy ± radiotherapy )
- •Within 120 days of completion of standard therapy (surgery, chemotherapy ± radiotherapy)
排除标准
- •Subjects with haemorrhagic diathesis (i.e. haemophilia).
- •Subjects with prior malignant tumors except for esophageal cancers in the past 5 years.
- •Subjects with documented or suspected central nervous system metastases.
- •Subjects with serious, nonhealing wound, ulcer, or bone fracture.
- •Subjects with a history of stroke, coronary arterial disease, angina, or vascular disease.
- •Subjects who are pregnant, lactating, or not using adequate contraception.
- •Subjects who have known allergy to NSAID or Aspirin.
- •Subjects receiving other antiplatelet agents (i.e. clopidogrel, ticlopidine) or anticoagulants (i.e. warfarin, low molecular weight heparins).
- •Subjects receiving current long term treatment (≥ 1 month) with Aspirin or other NSAIDs.
- •Subject unwilling or unable to comply with study requirements.
研究组 & 干预措施
Experimental Arm
Experimental Arm: acetylsalicylic acid (Aspirin) 100 mg OD for 3 years
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 5 years
Overall survival
时间窗: 5 years
次要结局
- Adverse events(5 years)
研究者
Yihua, Wu
Instructor
Zhejiang University