2024-516007-16-00招募中3 期
French prospective randomised double blind study on aspirin versus placebo in resected colon cancer with PI3K mutation stage III or II high risk (PRODIGE 50 - ASPIK)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Disease free survival at 3 years defined as the time from date of randomisation to date of first local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
研究概览
简要总结
To test the effectiveness of aspirin on the disease-free survival at 3 years after curative surgery for colon adenocarcinoma with PI3K mutation
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Colonic adenocarcinoma stage III (N+,M0) or Colonic adenocarcinoma stage II high risk MSS: a. T4bN0 or T4a tumour penetrating the surface of the visceral peritoneum; b. T3N0 with less than 12 nodes evaluated; c. T3N0 with at least 12 nodes evaluated but at least two of the following criteria: i. lymphatic involvement, ii. perineural invasion, iii. venous invasion; d. T3N0 with at least 12 nodes evaluated but at least one of the following criteria : i. diagnosis of bowel obstruction or perforation; ii. poor differentiated tumour.
- •PI3K mutation, exon 9 or 20 (tumour)
- •Status RAS known
- •Resection R0
- •WHO performance status 0-2
- •Chest and abdominal CT scan ≤ 12 weeks
- •Written consent signed
- •Women of childbearing age must agree to use effective contraception.
排除标准
- •Anticoagulant and/or Antiaggregating treatment including clopidogrel
- •Constitutional or acquired haemorrhagic disease include gastrointestinal bleeding, history of haemorrhagic and thrombotic stroke
- •Uncontrolled heart failure
- •Regular aspirin use (> 3 doses per week during more than 3 months the last year)
- •Follow-up of the patient not feasible for psychological, social or geographic reasons
- •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)
- •History of asthma induced by the administration of salicylate or close to active substances, including non-steroidal anti-inflammatory drugs
结局指标
主要结局
Disease free survival at 3 years defined as the time from date of randomisation to date of first local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Disease free survival at 3 years defined as the time from date of randomisation to date of first local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
次要结局
- Disease-free survival at 5 years
- Overall survival at 5 years
- Compliance to aspirin (comptability of containers)
- Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0
- Adverse event reported and graded according to NCI-CTC grading 4.0
- Serious Adverse events will also be described
- Subgroups analyses regarding mutations (KRAS and BRAF) for DFS and OS
研究者
David MALLET
Scientific
Centre Hospitalier Universitaire Rouen
研究点 (1)
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