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Spots Global Cancer Trial Database for Adjuvant Aspirin Treatment for Colon Cancer Patients

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Trial Identification

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

Conditions

Colon Cancer

Interventions

Aspirin
Placebo

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Überörtliche Gemeinschaftspraxis - Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin, Hamburg, , Germany

Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany

Medizinische Hochschule Hannover, Hannover, , Germany

Onkologische Schwerpunktpraxis Heidelberg, Heidelberg, , Germany

pioh KÖLN, Köln, , 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

Contact Details

Name: Ulrich GĂźller, Prof

Affiliation: Spital STS AG Thun

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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