Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,254
- 试验地点
- 1
- 主要终点
- 3-year disease free survival
研究概览
简要总结
The purpose of this study is to design a prospective randomized clinical trial to explore whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon cancer patients with high risk factors.Therefore the investigators can provide high level clinical evidence of indications for patients with colon cancer with stage II colon cancer.
详细描述
The most controversial of adjuvant chemotherapy for colon cancer is whether stage II colon cancer should receive adjuvant chemotherapy or not. Because of the absolute little benefit of adjuvant chemotherapy after curative resection of stage II colon cancer，NCCN and ESMO guidelines do not recommend routine adjuvant chemotherapy for patients with stage II colon cancer unless combined with high risk factors.
Currently，most studies about stage II colon cancer with high risk factors were retrospective. Some suggested that patients with stage II colon cancer can benefit from adjuvant chemotherapy, however, more got the negative conclusions.
The study was designed as a multicenter, prospective, randomized, controlled trial.Patients who agreed to participate in the study would be randomly assigned to a treatment group of adjuvant chemotherapy or observation with 50% chance by a central randomization system determined by the computer program.
After a follow up of at least 3 years, the disease free survival of the two groups will be compared.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 to 75 years;
- •pathologically confirmed adenocarcinoma of the colon
- •after curative resection pathological stage was T3-4N0M0;
- •with at least one of the following factors:
- •lymph nodes number less than 12
- •poor differentiation (except MSI-H)
- •obstruction or perforation
- •Elevated preoperative serum CEA
- •ECOG Performance status 0-1
- •no evidence of distant metastases
- •no preoperative chemotherapy or chemoradiation therapy
- •ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 xULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.
- •Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
排除标准
- •combined with other cancer
- •Creatinine level greater than 1.5 times the upper limit of normal.
- •Patients who have received preoperative chemotherapy or chemoradiotherapy.
- •Patients with a history of a prior malignancy within the past 5 years.
- •Women who are pregnant or breast-feeding.
- •patients may not complete the whole schedule of chemotherapy
- •Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
研究组 & 干预措施
adjuvant chemotherapy group
patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy[CapeOX（Capecitabine+Oxaliplatin）] by the current guidelines
干预措施: CapeOX（Capecitabine+Oxaliplatin） (Drug)
observation group
patients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation
干预措施: Observation (Other)
结局指标
主要结局
3-year disease free survival
时间窗: At least 3 years after the last patient enrolled
Disease free survival was defined as the duration after local recurrence or metastasis were found after surgery. Metastasis of any distant organs such as liver, lung, ovary，bone and peritoneum were defined by CT.
次要结局
- Major adverse events(At least 1 years after the last patient enrolled)
- 3-year overall survival(At least 3 years after the last patient enrolled)
- Rate of metastasis(At least 3 years after the last patient enrolled)
- Relationship between high risk factors and survival(At least 3 years after the last patient enrolled)
研究者
Aiwen Wu
M.D. PH.D. Chief, Unit III & Ostomy Service, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute
Peking University Cancer Hospital & Institute