Clinical Trial Details

EORTC-1401-BCG

Back to Clinical Trials Database

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

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) , EORTC Headquarters, Brussels
Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Julie Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels
Bart Meulemans (Data Manager) , EORTC Headquarters, Brussels
Coralie Poncet (Statistician) , EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) , 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 http://clinicaltrials.gov/ct/show/NCT02492607
NCT number NCT02492607
Financial Support External Grant