French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
研究概览
简要总结
Four retrospective studies were recently published on efficacy of aspirin in patients with surgically resected colon cancer. Two of these studies strongly suggested that aspirin used in low doses (100 mg/d) after surgical resection of colorectal cancer with PI3K mutation could act as a targeted therapy with a major protective effect on the risk of recurrence. The other two studies did not confirm the benefit of aspirin in this situation. These four retrospective studies provide an insufficient level of evidence to demonstrate the benefit of low-dose aspirin as adjuvant to surgery for colorectal cancer. Therefore, it is necessary as recommended in the conclusion of these studies and meta-analyses to perform a randomised prospective study to validate these data.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Colonic adenocarcinoma stage III
- •Colonic adenocarcinoma stage II high risk MSS:
- •T4bN0 or T4aN0 tumour penetrating the surface of the visceral peritoneum
- •or less than 12 nodes evaluated;
- •or with at least two of the following criteria:lymphatic involvement, perineural invasion, venous invasion
- •or diagnosis of bowel obstruction or perforation; or poor differentiated tumour.
- •PI3K mutation, exon 9 or 20 (tumour)
- •Resection R0
- •WHO performance status 0-2
- •Chest and abdominal CT scan ≤ 8 weeks
- •Life expectancy ≥ 3 years
- •Written consent signed
排除标准
- •Anticoagulant and/or Antiaggregating treatment including clopidogrel
- •Regular aspirin use (> 3 doses per week during more than 3 months the last year)
- •Contraindication to Aspirin : Allergy to aspirin, Active or antecedent peptic ulcer
- •Severe renal or hepatic insufficiency
- •Pregnancy or nursing ongoing
- •Rectal cancer
- •Hereditary forms (i.e. lynch syndrome patients)
- •Follow-up of the patient not feasible
研究组 & 干预措施
Patient with placebo intake
Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines. Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment
干预措施: Surgical resection of colonic adenocarcinoma stage III or II high risk (Procedure)
Patient with aspirin intake
Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines. Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment
干预措施: aspirin intake (Drug)
Patient with aspirin intake
Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines. Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment
干预措施: Surgical resection of colonic adenocarcinoma stage III or II high risk (Procedure)
Patient with aspirin intake
Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines. Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment
干预措施: Molecular analysis of exon 9 and 20 of PI3K (Biological)
Patient with aspirin intake
Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines. Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment
干预措施: blood intake (Biological)
Patient with placebo intake
Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines. Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment
干预措施: placebo intake (Drug)
Patient with placebo intake
Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines. Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment
干预措施: Molecular analysis of exon 9 and 20 of PI3K (Biological)
Patient with placebo intake
Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines. Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment
干预措施: blood intake (Biological)
结局指标
主要结局
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
时间窗: 3 years
次要结局
- Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first(5 years)
- Number of alive patient(5 years)
- Number of severe bleeding grade 3-4 events(3 years)
- Number of participants with treatment-related adverse events(3 years)
- Number of pills taken by the patient for compliance evaluation(every 6 months during 3 years)