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

Study acronym: ASPIK French
StatusActive, Not Recruiting
PhasePhase 3
Started2018-07-12
View on ClinicalTrials.gov ↗

Amendment history

2026-06-12
notable
Study Status, Contacts/Locations v4
Trial status changed: Recruiting → Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2026-02-17
minor
Study Status v3
Primary completion date2024-07→2028-07
Completion date2024-07→2028-07
2019-10-23
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-07→confirmed 2018-07-12
Study sitesdetails revised at 1 of 1 site
2018-05-25
minor
Study Status, Oversight, Contacts/Locations v1
Primary completion date2023-12→2024-07
Completion date2023-12→2024-07
Start date2016-12→2018-07
2016-10-24
minor
Original filing
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.
Trial Details
NCT Number NCT02945033
Lead Sponsor University Hospital, Rouen
Collaborators: Federation Francophone de Cancerologie Digestive
Conditions Colorectal Cancer
Enrollment 264 participants
Start Date 2018-07-12
Primary Completion 2028-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-15