Colon CancerPhase 3NCT02467582
Adjuvant Aspirin Treatment for Colon Cancer Patients
A Phase 3 study testing Aspirin in people with Colon Cancer, run by Swiss Cancer Institute at 60 sites in 4 countries.
Trial summary
Following complete resection of their primary tumor, potentially eligible stage II or stage III colon cancer patients will undergo central PIK3CA testing. Patients with somatic mutations will be 2:1 randomized to daily aspirin 100 mg versus placebo for a a maximum of 3 years or until disease recurrence, patient death… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,040 participants
- Where
- 60 sitesin 4 countries
- Study dates
- 9 Jun 2016to 14 Sep 2023
- Phase
- Phase 3
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
- Written informed consent according to ICH/GCP regulations before inclusion and prior to any trial-related investigations.
- Histologically confirmed diagnosis of adenocarcinoma of the colon.
- Stage II (pT3/T4 N0 cM0) or stage III (pTx pN+ cM0) colon cancer.
- Availability of cancer tissue for central molecular testing.
- Presence of predefined, activating PIK3CA mutation in exons 9 or 20 (centrally assessed).
- Complete resection of the primary tumor (R0) within 14 weeks maximum before registration.
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- WHO performance status 0-2.
- Age between 18-80 years.
- Adequate hematological values: hemoglobin ≥ 80 g/L, platelets ≥ 50 x 109/L.
- Adequate hepatic function: total bilirubin ≤1.5xULN, AST ≤2.5xULN, ALT ≤2.5xULN, AP ≤2.5xULN.
- Calculated creatinine clearance > 30 mL/min, according to the formula of Cockcroft-Gault.
- Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment. A negative pregnancy test before inclusion (within 7 days) into the trial is required for all women with child-bearing potential.
Who cannot join
- Previous or concomitant malignancy within 3 years of registration, except for adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
- Multiple adenocarcinomas of the colon.
- Rectal cancer (defined as distance from anal verge to proximal/oral tumor edge ≤15 cm).
- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction) within three months prior to registration.
- Systemic rheumatic diseases or degenerative disorders affecting the musculoskeletal system with a relevant risk of requiring treatment with NSAIDs in the future.
- Comorbidities that require regular (i.e. more than 3x per month, any dose) intake of acetylsalicylic acid or other NSAIDs or COX-2 inhibitors.
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- Clinically relevant upper gastro-intestinal bleeding within 12 months prior to registration.
- Presence of any bleeding disorder that is an absolute contraindication to the use of aspirin.
- General tendency to hypersensitivity and history of asthma triggered by salicylates or substances with a similar mechanism of action, and non-steroidal anti-inflammatory drugs in particular
- Any serious underlying medical condition, at the judgment of the investigator, which could impair the ability of the patient to participate in the trial (e.g. uncontrolled infection, active autoimmune disease, uncontrolled diabetes).
- Concurrent treatment with other experimental drugs or treatment in an interventional clinical trial within 30 days prior to trial entry. Concomitant use of adjuvant chemotherapy for stage III and high risk stage II colon cancer according to international treatment guidelines is allowed (chemotherapy regimens include intravenous 5-fluorouracil or oral capecitabine either alone or in combination with intravenous oxaliplatin).
- Psychiatric disorder precluding understanding of trial information, giving informed consent or interfering with compliance for oral drug intake.
- Any familial, sociological or geographical condition potentially hampering proper staging and compliance with the trial protocol.
- Known or suspected hypersensitivity to any component of the trial drug or any agent given in association with this trial.
- Known galactose-1-phosphate uridyl transferase deficiency, UDP galactose 4 epimerase deficiency, galactokinase deficiency, orFanconi-Bickel syndrome, congenital lactase deficiency,or glucose-galactose malabsorption (due to the lactose-containing placebo).
- Any concomitant drugs contraindicated for use with the trial drug according to the approved product information.
Trial locations and contacts
60 sites in 4 countries.
60 sites in 4 countries
Switzerland30 sites
Kantonsspital Aarau
Aarau, CH-5001
Kantonsspital Baden
Baden, 5404
Universitätsspital Basel
Basel, 4031
St. Claraspital Basel
Basel, 4058
IOSI, Ospedale San Giovanni
Bellinzona, 6500
Klinik Engeried / Oncocare
Bern, 3012
Inselspital Bern
Bern, CH-3010
Spitalzentrum Biel
Biel, CH-2501
Spitalzentrum Oberwallis
Brig, 3900
Kantonsspital Graubünden
Chur, 7000
HFR-Hôpital cantonal
Fribourg, 1708
CCAC Fribourg
Fribourg
Hopitaux Universitaires de Geneve
Geneva, 1211
Clinique de Genolier
Genolier, 1272
CCAC Lausanne
Lausanne, 1004
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Kantonsspital Liestal
Liestal, 4410
Kantonsspital Luzern
Lucerne, 6000
Clinica Luganese
Lugano, 6900
Onkologie Zentrum Spital Männedorf
Manno, 8708
Spital Thurgau
Münsterlingen, 8596
Hôpital de Pourtalès
Neuchâtel
Kantonsspital Olten
Olten, CH-4600
Kantonsspital St. Gallen
Sankt Gallen, 9007
Spital Limmattal
Schlieren, 8952
Hôpital du Valais Sion
Sion, 1951
Bürgerspital Solothurn - Onkologiezentrum
Solothurn, 4600
SpitalSTS AG Simmental-Thun-Saanenland
Thun, 3600
Kantonsspital Winterthur
Winterthur, CH-8400
Stadtspital Zürich Triemli
Zurich, CH-8063
Germany23 sites
Spandau Vivantes Klinikum
Berlin, 13585
Fürst-Stirum-Klinik Bruchsal
Bruchsal, 76646
pioh KÖLN
Cologne, 50674
Universitätsklinikum Dresden
Dresden, 01307
Kliniken Essen Mitte
Essen, 45136
pioh Frechen
Frechen, 50226
Praxis und Tagesklinik - Medizinische Management GmbH
Friedrichshafen, 88045
Überörtliche Gemeinschaftspraxis - Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin
Hamburg, 20259
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Medizinische Hochschule Hannover
Hanover, 30625
Onkologische Schwerpunktpraxis Heidelberg
Heidelberg, 69115
Onkologie UnterEms
Leer, 26789
Klinikum Ludwigsburg
Ludwigsburg, 71640
Universitätsmedizin Mannheim
Mannheim, 68135
Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus
Mönchengladbach, 41063
Medizinische Klinik und Poliklinik III - Universitätsklinik
München, 83177
Klinikum Nuernberg
Nuremberg, 90419
Pi.Tri-Studien GmbH
Offenburg, 77654
CaritasKlinikum Saarbrücken
Saarbrücken, 66113
Marienhospital
Stuttgart, 70199
Klinik für Innere Medizin I
Ulm, 89081
Medizinische Studiengesellschaft NORD-WEST GmbH - Praxis Aurich
Westerstede, 26655
Medizinische Studiengesellschaft NORD-WEST GmbH
Westerstede, 26655
Belgium6 sites
Hopital Universitaire Brugmann
Brussels, 1020
Universitair Ziekenhuis Brussel
Brussels, 1090
Hôpital de Jolimont
Haine-Saint-Paul, 7100
CHC - Clinique Saint-Joseph
Liège, 4000
Az Damiaan
Ostend, 8400
AZ Turnhout - Campus Sint-Elisabeth
Turnhout, 2300
About this study
Official title: Adjuvant Aspirin Treatment in PIK3CA Mutated Colon Cancer Patients. A Randomized, Double-blinded, Placebo-controlled, Phase III Trial
Following complete resection of their primary tumor, potentially eligible stage II or stage III colon cancer patients will undergo central PIK3CA testing. Patients with somatic mutations will be 2:1 randomized to daily aspirin 100 mg versus placebo for a a maximum of 3 years or until disease recurrence, patient death or withdrawal of consent, whichever occurs first. Patients will be followed up for at least 3 years from the date of surgery.
The intake of aspirin or placebo is independent of adjuvant chemotherapy, and does not impact on the indication to give (or not to give) adjuvant chemotherapy.
Read the detailed description
Colorectal cancer is the third most common malignancy for both women and men and is responsible for almost 10% of all cancer death. Despite complete removal of the tumor and use of adjuvant chemotherapy, up to 25% of patients with stage II colon cancer and up to 50% of patients with stage III disease will suffer from recurrences, which is associated with poor prognosis.
Several retrospective observations have documented a favorable effect of long-term intake of oral aspirin for the prevention of colorectal cancer in different clinical situations. Regular intake of aspirin after the diagnosis of colorectal cancer may also be associated with a lower risk of colorectal cancer-specific and overall mortality. Two recent publications in prestigious medical journals provided retrospective evidence that patients with PIK3CA-mutated colon cancer may derive a very substantial benefit from daily oral aspirin. Both analyses showed a roughly 85% reduction of the risk for tumor relapse compared to patients who did not take aspirin. However, a potential selection bias in these retrospective analyses cannot be excluded with certainty. These extremely interesting and intriguing findings must be confirmed in a randomized controlled trial to potentially change clinical practice.
The trial objective is to demonstrate a statistically significant and clinically relevant disease-free survival benefit in stage II and III PIK3CA mutated colon cancer patients taking daily adjuvant aspirin for 3 years.
Patients with resected colon cancer stage II or stage III bearing somatic mutations in exon 9 or 20 of PIK3CA will be 2:1 randomized to daily adjuvant aspirin 100 mg versus placebo for a maximum of 3 years or until disease recurrence, patient death or withdrawal of consent, whichever occurs first. Patients will be followed up for at least 3 years from the date of surgery. The intake of aspirin or placebo is independent of adjuvant chemotherapy, and does not impact on the indication to give (or not to give) adjuvant chemotherapy.
- Conditions
- Colon Cancer
- Being tested
- Aspirin, Placebo
- Keywords
- Aspirin, colon cancer, stage II, stage III, PIK3CA, double-blind, placebo, Adjuvant Treatment
- Medical subject headings
- Colonic Neoplasms, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called acetylsalicylic acid
Aspirin 100 mg daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 100 mg | Experimental | Asprin 100 mg daily for maximum 3 years standard chemo if indicated Receives: Drug: Aspirin |
| Placebo | Active comparator | Placebo daily for maximum 3 years standard chemo if indicated Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS)
The primary endpoint of this trial is DFS, defined as time from surgery until one of the following events, whichever comes first:
- recurrence
- second cancer
- death due to any reason Patients not experiencing an event will be censored at the date of the last available tumor assessment.
Measured: up to 7 years
Secondary outcomes (4)
Time to Recurrence (TTR)
TTR was calculated from surgery until recurrence or death due to colon cancer. Patients not experiencing an event or patients who died due to other reasons before experiencing an event were censored at the date of the last available tumor assessment.
Measured: up to 7 years
Overall Survival (OS)
OS was calculated from surgery until death from any cause. Patients not experiencing an event were censored at the last date they were known to be alive.
Measured: up to 7 years
Cancer-specific Survival (CSS)
CSS was calculated from surgery until death due to colon cancer, whether due to the original tumor or to a second primary same cancer. Patients who died due to other reasons were censored at the time of death. All other patients were censored at the last date they were known to be alive.
Measured: up to 7 years
Adverse Events (AEs)
Measured: During treatment (median 22.1 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start9 Jun 2016
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Why it stopped: Board decision in 2020 due to lack of financial funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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, Care provider, Investigator
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC, Central European Society for Anticancer Drug Research
- Responsible party
- Sponsor
- Investigators
- Ulrich Güller, Prof, Study chair, Spital STS AG Thun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467582
- Sponsor's protocol ID
- SAKK 41/13 - Aspirin
- Other IDs
- SNCTP000001339, 2015-001482-57, 2015
- Status last verified
- May 2025
- First submitted
- 5 Jun 2015
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No