Running, not taking new patientsPhase 3Randomised
| Registry number | NCT02945033 |
|---|---|
| Recruitment | Running, not taking new patients |
| Phase | Phase 3 |
| Design | randomised, blinded |
| Taking part | 264 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | University Hospital, Rouen |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug aspirin intake
- 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 it is measuring
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- PIK3CA mutated
- Locally advanced
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: France.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT02945033, registered by University Hospital, Rouen on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.