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Brief Title: Adjuvant Aspirin Treatment for Colon Cancer Patients
Official Title: Adjuvant Aspirin Treatment in PIK3CA Mutated Colon Cancer Patients. A Randomized, Double-blinded, Placebo-controlled, Phase III Trial
Study ID: NCT02467582
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.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hopital Universitaire Brugmann, Brussels, , Belgium
Universitair Ziekenhuis Brussel, Brussels, , Belgium
HĂ´pital de Jolimont, Haine-Saint-Paul, , Belgium
CHC - Clinique Saint-Joseph, Liège, , Belgium
Az Damiaan, Oostende, , Belgium
AZ Turnhout - Campus Sint-Elisabeth, Turnhout, , Belgium
Spandau Vivantes Klinikum, Berlin, , Germany
FĂźrst-Stirum-Klinik Bruchsal, Bruchsal, , Germany
Universitätsklinikum Dresden, Dresden, , Germany
Kliniken Essen Mitte, Essen, , Germany
pioh Frechen, Frechen, , Germany
Praxis und Tagesklinik - Medizinische Management GmbH, Friedrichshafen, , Germany
ĂberĂśrtliche Gemeinschaftspraxis - Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin, Hamburg, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Onkologische Schwerpunktpraxis Heidelberg, Heidelberg, , Germany
pioh KĂLN, KĂśln, , Germany
Onkologie UnterEms, Leer, , Germany
Klinikum Ludwigsburg, Ludwigsburg, , Germany
Universitätsmedizin Mannheim, Mannheim, , Germany
Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus, MĂśnchengladbach, , Germany
Medizinische Klinik und Poliklinik III - Universitätsklinik, Mßnchen, , Germany
Klinikum Nuernberg, Nuernberg, , Germany
Pi.Tri-Studien GmbH, Offenburg, , Germany
CaritasKlinikum SaarbrĂźcken, SaarbrĂźcken, , Germany
Marienhospital, Stuttgart, , Germany
Klinik fĂźr Innere Medizin I, Ulm, , Germany
Medizinische Studiengesellschaft NORD-WEST GmbH - Praxis Aurich, Westerstede, , Germany
Medizinische Studiengesellschaft NORD-WEST GmbH, Westerstede, , Germany
St. LĂĄszlĂł Teaching Hospital, Budapest, , Hungary
Kantonsspital Baden, Baden, , Switzerland
Universitätsspital Basel, Basel, , Switzerland
St. Claraspital Basel, Basel, , Switzerland
IOSI, Ospedale San Giovanni, Bellinzona, , Switzerland
Klinik Engeried / Oncocare, Bern, , Switzerland
Inselspital Bern, Bern, , Switzerland
Spitalzentrum Oberwallis, Brig, , Switzerland
Kantonsspital GraubĂźnden, Chur, , Switzerland
HFR-HĂ´pital cantonal, Fribourg, , Switzerland
CCAC Fribourg, Fribourg, , Switzerland
Hopitaux Universitaires de Geneve, Genève 14, , Switzerland
Kantonsspital Liestal, Liestal, , Switzerland
Clinica Luganese, Lugano, , Switzerland
Kantonsspital Luzern, Luzern, , Switzerland
Onkologie Zentrum Spital Männedorf, Manno, , Switzerland
Spital Thurgau, Munsterlingen, , Switzerland
Hôpital de Pourtalès, Neuchâtel, , Switzerland
HĂ´pital du Valais Sion, Sion, , Switzerland
Kantonsspital St. Gallen, St. Gallen, , Switzerland
SpitalSTS AG Simmental-Thun-Saanenland, Thun, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Stadtspital ZĂźrich Triemli, Zurich, , Switzerland
Name: Ulrich GĂźller, Prof
Affiliation: Spital STS AG Thun
Role: STUDY_CHAIR