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NCT Number: NCT02945033

Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

aspirin intake

Drug

Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years

placebo intake

Drug

Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years

Surgical resection of colonic adenocarcinoma stage III or II high risk

Procedure

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

Biological

Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece

blood intake

Biological

Blood intake will be done every 6 months to evaluate patient compliance to treatment

Primary outcomes

  1. Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first

    Time frame: 3 years

Secondary outcomes

  1. Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first

    Time frame: 5 years

  2. Number of alive patient

    Time frame: 5 years

  3. Number of pills taken by the patient for compliance evaluation

    Time frame: every 6 months during 3 years

    Number of pills taken by the patient will be assess in order to evaluate patient's compliance

  4. Number of severe bleeding grade 3-4 events

    Time frame: 3 years

  5. Number of participants with treatment-related adverse events

    Time frame: 3 years

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • Federation Francophone de Cancerologie Digestive

Registry information

Official study title

French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation

Acronym: ASPIK French

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Oct 26, 2016
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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