Content - SAKK 41/13

SAKK 41/13 – Aspirin for the prevention of recurrent colorectal cancer

A number of studies show that patients with colorectal cancer who regularly take low-dose aspirin experience a more favorable disease progression than patients who do not. This is particularly true of patients with a modified PI3K gene (PIK3CA mutation) in their tumor cells. In such patients, aspirin is believed to reduce the risk of a recurrence (relapse) after treatment for colorectal cancer. However, the results of current investigations into the role played by aspirin were compiled retrospectively and are somewhat equivocal. This is why the SAKK is now conducting its own study.

In the SAKK 41/13 trial, patients who have been treated for colorectal cancer and who are known to have a PIK3CA mutation will take aspirin or placebo every day for three years. They will be randomly assigned to the aspirin or placebo group, with two thirds of patients receiving aspirin and one third receiving placebo.

Study Chair:

Prof. Dr. med. Ulrich Güller, Cantonal Hospital of St.Gallen, +41 71 494 11 11

  • Contacts at the hospitals

  • Inclusion criteria

    • 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 10 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.
    • 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.
  • Exclusion criteria

    • 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).
    • Any concomitant drugs contraindicated for use with the trial drug according to the approved product information.

Locations for this trial:

Kantonsspital Aarau
Tellstrasse 25
0 5001 Aarau
Kantonsspital Baden
Im Ergel 1
4600 Baden
St. Claraspital AG
Kleinriehenstrasse 30
0 4058 Basel
Universitätsspital Basel
Petersgraben 4
0 4031 Basel
Istituto Oncologico della Svizzera Italiana IOSI
Via Ospedale
0 6500 Bellinzona
Inselspital
Freiburgstrasse 8
3010 Bern
Spitalzentrum Biel
Vogelsang 84
0 2501 Biel
Spitalzentrum Oberwallis
Ueberlandstrasse 14
0 3902 Brig
Kantonsspital Graubünden
Loëstrasse 170
7000 Chur
Hôpital Fribourgeois HFR
Chemin des Pensionnats 2
1708 1708 Fribourg
Hôpitaux Universitaires de Genève HUG
Rue Gabrielle-Perret-Gentil 4
0 1205 Genève
Clinique de Genolier
Route du Muids 3
0 1272 Genolier
Centre de Chimiothérapie Anti-Cancéreuse
-
0 1004 Lausanne
Centre Hospitalier Universitaire Vaudois CHUV
Rue du Bugnon 46
0 Lausanne
Kantonsspital Liestal
Rheinstrasse 26
0 4410 Liestal
Kantonsspital Luzern
Spitalstrasse
0 6000 Luzern
Spital Männedorf AG
Asylstrasse 10
0 8708 Männedorf
Hôpital neuchâtelois
Chasseral 20
0 2303 La Chaux-de-Fonds
Kantonsspital Olten
Baslerstrasse 150
0 4600 Olten
Hôpital du Valais Sion
Avenue du Grand-Champsec 80
0 1951 Sion
Kantonsspital St. Gallen
Rorschacher Strasse 95
0 9007 St. Gallen
Spital STS AG Thun
Krankenhausstrasse 12
0 3600 Thun
Spital Thurgau, Kantonsspital Frauenfeld
Waldeggstrasse 8A
0 8501 Frauenfeld
Kantonsspital Winterthur
Brauerstrasse 15
0 8401 Winterthur
Spital Limmattal
Urdorferstrasse 100
0 8952 Schlieren
Stadtspital Triemli
Birmensdorferstrasse 497
0 8063 Zürich