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Protocol SAKK 41/13 Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double-blinded, placebo-controlled, phase III trial

Study documentation

Trial Status Recruiting
Dates Date of activation: 08-Aug-2017
Data management at EORTC No
Design Phase 3
Randomized blind
Targeted Sample size EORTC Groups: 59 - All Groups: 1850
Treatment Drug
Acetylsalicylic acid
Study Staff Thibaud Koessler (Study Coordinator) , Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie, Geneve
Giovanna Farro (Clinical Scientist) , EORTC Headquarters, Brussels
Marie-Ange Lentz (Data Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Murielle Mauer (Statistician) , EORTC Headquarters, Brussels
Khadija Rhioui (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Sophie Schrevens (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels
Maira Seini (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Sofie Verschueren (Clinical Operations Manager) , EORTC Headquarters, Brussels
Zineb Wadid (Lead CRA) , EORTC Headquarters, Brussels
Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels
Type of cancer Colorectal
Participating groups EORTC Gastrointestinal Tract Cancer Group
Schweizerisches Arbeitsgemeinschaft Klin. Krebsforschung
Central European Society for Anticancer Drug Research-EWIV
Recruiting centers AZ Damiaan (Oostende, Belgium)
AZ Turnhout - Campus Sint Elisabeth (Turnhout, Belgium)
CHC - Clinique Saint-Joseph (Liege, Belgium)
CaritasKlinikum Saarbruecken St Theresia (Saarbruecken, Germany)
Hopital De Jolimont (Haine St Paul, Belgium)
Hopital Universitaire Brugmann (Brussels, Belgium)
Kliniken Essen-Mitte (Essen, Germany)
Klinikum Ludwigsburg (Ludwigsburg, Germany)
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
Marienhospital Stuttgart (Stuttgart, Germany)
Onkologische Praxis Heidelberg (Heidelberg, Germany)
Universitaets-Krankenhaus Eppendorf (Hamburg, Germany)
UniversitaetsMedizin Mannheim (Mannheim, Germany)
Universitaetsklinikum Carl Gustav Carus (Dresden, Germany)
Universitair Ziekenhuis Brussel (Brussels, Belgium)
Vivantes Klinikum Spandau (Berlin, Germany)
Protocol summary
NCT number NCT02467582
EudraCT 2015-001482-57
Financial Support Educational Grant