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Management of low grade ductal carcinoma in situ (low-grade DCIS): a randomized, multicenter, non-inferiority trial, between standard therapy approach versus active surveillance

Study documentation
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Trial Status Recruiting
Dates Date of activation: 30-Jan-2017
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size All Groups: 1240
Treatment Radiotherapy, Drug
Study Staff Jelle Wesseling (Study Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam
Melanie Beauvois (Clinical Operations Manager) melanie.beauvois (at), EORTC Headquarters, Brussels
Christine Bourguignon (Clinical Operations Assistant) christine.bourguignon (at), EORTC Headquarters, Brussels
Julie Hermans (Regulatory Affairs Manager) julie.hermans (at), EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at), EORTC Headquarters, Brussels
Livia Meirsman (Project Manager) livia.meirsman (at), EORTC Headquarters, Brussels
Bart Meulemans (Data Manager) bart.meulemans (at), EORTC Headquarters, Brussels
Coralie Poncet (Statistician) coralie.poncet (at), EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) sandrine.rivrain (at), EORTC Headquarters, Brussels
Type of cancer Breast
Participating groups EORTC Breast Cancer Group
Borstkanker Onderzoeksgroup Nederland
The Netherland Cancer Institute
Recruiting centers CHU Saint-Pierre-Site Porte de Hal (Brussels, Belgium)
Hopital Universitaire Brugmann (Brussels, Belgium)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
ZNA Jan Palfijn (Merksem, Belgium)
ZNA Middelheim (Antwerpen, Belgium)
Centers to be activated CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
Hopital Universitaires Erasme (Brussels, Belgium)
Protocol summary
NCT number NCT02492607