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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)
EU CTIS ID: 2024-516007-16-00
What this study is testing
To test the effectiveness of aspirin on the disease-free survival at 3 years after curative surgery for colon adenocarcinoma with PI3K mutation
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.