Adjuvant Aspirin Treatment for Colon Cancer Patients

NCT02467582 | Terminated Phase 3 Results

• 3 other identifiers: SAKK 41/13 - AspirinSNCTP0000013392015-001482-57
• Study Type: interventional
• Target: 1,040
• Locations: 4 countries
• Sites: 60

Brief 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 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

Keywords

Aspirin; colon cancer; stage II; stage III; PIK3CA; double-blind; placebo; Adjuvant Treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 7 years

Secondary Outcomes (4)

• Time to Recurrence (TTR)

  up to 7 years

• Overall Survival (OS)

  up to 7 years

• Cancer-specific Survival (CSS)

  up to 7 years

• Adverse Events (AEs)

  During treatment (median 22.1 months)

Study Arms (2)

Aspirin 100 mg

EXPERIMENTAL

Asprin 100 mg daily for maximum 3 years standard chemo if indicated

Drug: Aspirin

Placebo

ACTIVE COMPARATOR

Placebo daily for maximum 3 years standard chemo if indicated

Drug: Placebo

Interventions

Aspirin DRUG

Aspirin 100 mg daily

Also known as: acetylsalicylic acid

Aspirin 100 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Swiss Cancer Institute: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• Central European Society for Anticancer Drug Research: collaborator

Study Sites (60)

Hopital Universitaire Brugmann

Brussels, 1020, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Hôpital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

CHC - Clinique Saint-Joseph

Liège, 4000, Belgium

Location

Az Damiaan

Ostend, 8400, Belgium

Location

AZ Turnhout - Campus Sint-Elisabeth

Turnhout, 2300, Belgium

Location

Spandau Vivantes Klinikum

Berlin, 13585, Germany

Location

Fürst-Stirum-Klinik Bruchsal

Bruchsal, 76646, Germany

Location

pioh KÖLN

Cologne, 50674, Germany

Location

Universitätsklinikum Dresden

Dresden, 01307, Germany

Location

Kliniken Essen Mitte

Essen, 45136, Germany

Location

pioh Frechen

Frechen, 50226, Germany

Location

Praxis und Tagesklinik - Medizinische Management GmbH

Friedrichshafen, 88045, Germany

Location

Überörtliche Gemeinschaftspraxis - Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin

Hamburg, 20259, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Onkologische Schwerpunktpraxis Heidelberg

Heidelberg, 69115, Germany

Location

Onkologie UnterEms

Leer, 26789, Germany

Location

Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

Location

Universitätsmedizin Mannheim

Mannheim, 68135, Germany

Location

Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus

Mönchengladbach, 41063, Germany

Location

Medizinische Klinik und Poliklinik III - Universitätsklinik

München, 83177, Germany

Location

Klinikum Nuernberg

Nuremberg, 90419, Germany

Location

Pi.Tri-Studien GmbH

Offenburg, 77654, Germany

Location

CaritasKlinikum Saarbrücken

Saarbrücken, 66113, Germany

Location

Marienhospital

Stuttgart, 70199, Germany

Location

Klinik für Innere Medizin I

Ulm, 89081, Germany

Location

Medizinische Studiengesellschaft NORD-WEST GmbH - Praxis Aurich

Westerstede, 26655, Germany

Location

Medizinische Studiengesellschaft NORD-WEST GmbH

Westerstede, 26655, Germany

Location

St. László Teaching Hospital

Budapest, H - 1097, Hungary

Location

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

St. Claraspital Basel

Basel, 4058, Switzerland

Location

IOSI, Ospedale San Giovanni

Bellinzona, 6500, Switzerland

Location

Klinik Engeried / Oncocare

Bern, 3012, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Spitalzentrum Oberwallis

Brig, 3900, Switzerland

Location

Kantonsspital Graubünden

Chur, 7000, Switzerland

Location

HFR-Hôpital cantonal

Fribourg, 1708, Switzerland

Location

CCAC Fribourg

Fribourg, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, 1211, Switzerland

Location

Clinique de Genolier

Genolier, 1272, Switzerland

Location

CCAC Lausanne

Lausanne, 1004, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital Liestal

Liestal, 4410, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Clinica Luganese

Lugano, 6900, Switzerland

Location

Onkologie Zentrum Spital Männedorf

Manno, 8708, Switzerland

Location

Spital Thurgau

Münsterlingen, 8596, Switzerland

Location

Hôpital de Pourtalès

Neuchâtel, Switzerland

Location

Kantonsspital Olten

Olten, CH-4600, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Spital Limmattal

Schlieren, 8952, Switzerland

Location

Hôpital du Valais Sion

Sion, 1951, Switzerland

Location

Bürgerspital Solothurn - Onkologiezentrum

Solothurn, 4600, Switzerland

Location

SpitalSTS AG Simmental-Thun-Saanenland

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

Stadtspital Zürich Triemli

Zurich, CH-8063, Switzerland

Location

MeSH Terms

Conditions

Colonic Neoplasms; Hereditary Sensory and Autonomic Neuropathies

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

small sample size

Results Point of Contact

• Title: Regulatory affairs
• Organization: SAKK

regulatory@sakk.ch

+41 31 389 91 91

Study Officials

• Ulrich Güller, Prof

  Spital STS AG Thun

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 10, 2015
• Study Start: June 9, 2016
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); DE (23); CH (30); BE (6)