Colorectal CancerPhase 3ASPIK FrenchNCT02945033
Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk
A Phase 3 study testing aspirin intake, Surgical resection of colonic adenocarcinoma stage III or II high risk and Molecular analysis of exon 9 and 20 of PI3K in people with Colorectal Cancer, run by University Hospital, Rouen at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- aspirin intake, Surgical resection of colonic adenocarcinoma stage III or II high risk and Molecular analysis of exon 9 and 20 of PI3K
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2018to Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation
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.
- Conditions
- Colorectal Cancer
- Being tested
- aspirin intake, placebo intake, Surgical resection of colonic adenocarcinoma stage III or II high risk, Molecular analysis of exon 9 and 20 of PI3K, blood intake
- Keywords
- Pi3k mutation, Aspirin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin intakeDrug
Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
placebo intakeDrug
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 riskProcedure or surgery
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 PI3KBiological
Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece
blood intakeBiological
Blood intake will be done every 6 months to evaluate patient compliance to treatment
| Study group | Role | What they receive |
|---|---|---|
| Patient with aspirin intake | Experimental | 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 Receives: Drug: aspirin intake; Procedure: Surgical resection of colonic adenocarcinoma stage III or II high risk; Biological: Molecular analysis of exon 9 and 20 of PI3K; Biological: blood intake |
| Patient with placebo intake | Placebo comparator | 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 Receives: Drug: placebo intake; Procedure: Surgical resection of colonic adenocarcinoma stage III or II high risk; Biological: Molecular analysis of exon 9 and 20 of PI3K; Biological: blood intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Measured: 3 years
Secondary outcomes (5)
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Measured: 5 years
Number of alive patient
Measured: 5 years
Number of pills taken by the patient for compliance evaluation
Number of pills taken by the patient will be assess in order to evaluate patient's compliance
Measured: every 6 months during 3 years
Number of severe bleeding grade 3-4 events
Measured: 3 years
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start12 Jul 2018
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Federation Francophone de Cancerologie Digestive
- Responsible party
- Sponsor
- Investigators
- Pierre MICHEL, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945033
- Sponsor's protocol ID
- 2015/222/HP
- Acronym
- ASPIK French
- Status last verified
- Jun 2026
- First submitted
- 20 Oct 2016
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation
- ClinicalTrials.gov ID
- NCT02945033
- Acronym / sponsor ID
- ASPIK French / 2015/222/HP
- Conditions
- Colorectal Cancer
- Keywords
- Pi3k mutation, Aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Federation Francophone de Cancerologie Digestive
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with aspirin intake | Experimental | Drug: aspirin intake, Procedure: Surgical resection of colonic adenocarcinoma stage III or II high risk, Biological: Molecular analysis of exon 9 and 20 of PI3K, Biological: blood intakeSurgical 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 |
| Patient with placebo intake | Placebo comparator | Drug: placebo intake, Procedure: Surgical resection of colonic adenocarcinoma stage III or II high risk, Biological: Molecular analysis of exon 9 and 20 of PI3K, Biological: blood intakeSurgical 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years
- Colonic adenocarcinoma stage III
- Colonic adenocarcinoma stage II high risk MSS:
- PI3K mutation, exon 9 or 20 (tumour)
- Resection R0
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin intakePatient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years | Drug | Patient with aspirin intake |
| placebo intakePatient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years | Drug | Patient with placebo intake |
| Surgical resection of colonic adenocarcinoma stage III or II high riskSurgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines | Procedure or surgery | Patient with aspirin intake, Patient with placebo intake |
| Molecular analysis of exon 9 and 20 of PI3KMolecular analysis of exon 9 and 20 of PI3K will be done using operative piece | Biological | Patient with aspirin intake, Patient with placebo intake |
| blood intakeBlood intake will be done every 6 months to evaluate patient compliance to treatment | Biological | Patient with aspirin intake, Patient with placebo intake |
Primary outcome
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time frame: 3 years
5 secondary outcomes
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time frame: 5 years
Number of alive patient
Time frame: 5 years
Number of pills taken by the patient for compliance evaluation
Time frame: every 6 months during 3 years
Number of severe bleeding grade 3-4 events
Time frame: 3 years
Number of participants with treatment-related adverse events
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre MICHEL, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aspirin intake, Surgical resection of colonic adenocarcinoma stage III or II high risk and Molecular analysis of exon 9 and 20 of PI3K in people with Colorectal Cancer, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.