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	Closed to Patient Entry
Dates	Date of activation: 08-Aug-2017 Date Step1 close: 19-Jan-2021 Date Step2 close: 19-Jan-2021
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) , Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie, Geneve Marie-Ange Lentz (Data Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Murielle Mauer (Statistician) , EORTC Headquarters, Brussels Maira Seini (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Sofie Verschueren (Clinical Operations Manager) , 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) CHC MontLegia (Liege, Belgium) CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium) Caritas Traegergescellschaft Saarbruecken mbH - CaritasKlinikum Saarbruecken St Theresia (Saarbruecken, Germany) Hopital Universitaire Brugmann (Brussels, Belgium) Kliniken Essen-Mitte (Essen, Germany) Klinikum Ludwigsburg (Ludwigsburg, Germany) Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany) Onkologische Praxis Heidelberg (Heidelberg, Germany) UniversitaetsMedizin Mannheim (Mannheim, Germany) Universitaetsklinikum Carl Gustav Carus (TUD) (Dresden, Germany) Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany) Universitair Ziekenhuis Brussel (Brussels, Belgium) Vinzenz Von Paul Kliniken (Stuttgart, Germany)
Protocol summary	http://clinicaltrials.gov/study/NCT02467582
NCT number	NCT02467582
EudraCT	2015-001482-57
Financial Support	Educational Grant EORTC Group