Clinical Trial Details

EORTC-1534-GITCG

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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 http://clinicaltrials.gov/ct/show/NCT02467582
NCT number NCT02467582
EudraCT 2015-001482-57
Financial Support Educational Grant
EORTC Group