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Can a daily aspirin help fight colorectal cancer? new trial targets genetic weakness

NCT ID NCT02647099

Disease control Sponsor: Anna Martling Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether low-dose aspirin can help prevent colorectal cancer from coming back in patients whose tumors have certain genetic changes (in the PI3K pathway). Over 600 patients who had surgery for stage II or III colon or rectal cancer are randomly assigned to take aspirin or a placebo daily. The main goal is to see if aspirin delays or prevents cancer recurrence within three years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

626 people

The number who actually took part.

Started

Apr 2016

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN * Colon or rectal cancer tumor stage II-III * Radical surgery according to surgeon and pathologist * Karnofsky performance status ≥60% * Platelets ≥ 100 x 109 / L * Clean Colonoscopy or Computed Tomography (CT) colon within 3 months preoperatively or postoperatively but before randomization * Patient able to swallow tablets * Patient able to understand and sign written informed consent Exclusion Criteria: * Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) * Distant metastases * Other cancers (excluding colorectal cancer or other skin cancer than melanoma) within 3 years from screening * Known bleeding diathesis (such as hemophilia) * Concomitant antiplatelet therapy (eg clopidrogrel or ticlopidine) or anticoagulant therapy (warfarin or low molecular weight heparin). Post-operative treatment with low molecular weight heparin must be withdrawn before administration of study treatment * Active gastritis or peptic ulcer, or significant surgical post-op bleeding, within the previous three months assessed at screening and randomization * Ongoing regular use of corticosteroids, Nonsteroidal Anti-Inflammatory Drug (NSAID) * Uncontrolled hypertension according to Investigator's judgment * Clinically significant liver impairment according to Investigators judgment * Existing renal failure according to Investigator's judgment. Renal failure with decreased creatinine clearance \<60 should lead to consultation with a nephrologist. * Significant medical illness that would interfere with study participation * Pregnancy or breastfeeding females * Known allergy to NSAIDs or ASA * Current participation in another clinical trial that will be in conflict with the present study * Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Akershus University Hospital

    Oslo, Norway

  • Blekinge Hospital (Karlskrona-Karlshamn)

    Karlskrona, Sweden

  • Capio S:t Göran Hospital

    Stockholm, Sweden

  • Danderyd Hospital

    Stockholm, Sweden

  • Eastern Hospital

    Gothenburg, Sweden

  • Ersta Hospital

    Stockholm, Sweden

  • Falu Hospital

    Falun, Sweden

  • Jorvi Hospital

    Espoo, Finland

  • Karlstad Central Hospital

    Karlstad, Sweden

  • Karolinska University Hospital

    Stockholm, Sweden

  • Linköping University Hospital

    Linköping, Sweden

  • Meilahti Tower Hospital

    Helsinki, Finland

  • Mora Hospital

    Mora, Sweden

  • Northern Älvsborg County Hospital

    Trollhättan, Sweden

  • Randers Regional Hospital

    Randers, Denmark

  • Ryhov Hospital

    Jönköping, Sweden

  • Skaraborg Hospital

    Skövde, Sweden

  • Skåne University Hospital

    Malmö, Sweden

  • South Hospital

    Stockholm, Sweden

  • St Olavs Hospital

    Trondheim, Norway

  • Stavanger University Hospital

    Stavanger, Norway

  • Sunderby Hospital

    Luleå, Sweden

  • Sundsvall Regional Hospital (Sundsvall-Härnösand)

    Sundsvall, Sweden

  • University Hospital of North Norway

    Tromsø, Norway

  • University Hospital of Umeå

    Umeå, Sweden

  • Uppsala University Hospital

    Uppsala, Sweden

  • Viborg Region Hospital

    Viborg, Denmark

  • Vrinnevi Hospital

    Norrköping, Sweden

  • Västerås Central Hospital

    Västerås, Sweden

  • Ystad Hospital

    Ystad, Sweden

  • Örebro University Hospital

    Örebro, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.