Clinical Trial Details

EORTC-22085-10083-ROG-BCG

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A randomized phase III study of radiation doses and fractionation schedules for ductal carcinoma in situ (DCIS) of the breast.

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 18-Jan-2010
Date Step1 close: 02-Jul-2014
Data management at EORTC No
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 400 - All Groups: 1600
Treatment Radiotherapy
Study Staff Helen Westenberg (Study Coordinator) , Radiotherapiegroep Arnhem, Arnhem
Pierre-Edouard Dollet (Clinical Operations Manager) pierre.dollet (at) eortc.org, EORTC Headquarters, Brussels
Catherine Fortpied (Statistician) catherine.fortpied (at) eortc.org, EORTC Headquarters, Brussels
Livia Giurgea (Data Manager) livia.giurgea (at) eortc.org, EORTC Headquarters, Brussels
Julie Hermans (Regulatory Affairs Manager) julie.hermans (at) eortc.org, EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations Manager) gaetan.deschaetzen (at) eortc.org, EORTC Headquarters, Brussels
Type of cancer Breast
Participating groups EORTC Breast Cancer Group
EORTC Radiation Oncology Group
Breast International Group
Trans-Tasman Radiation Oncology Group Inc
Borstkanker Onderzoeksgroup Nederland
Recruiting centers AZ Groeninge – Oncology Centre (Kortrijk, Belgium)
Academisch Medisch Centrum - Universiteit van Amsterdam (Amsterdam, Netherlands)
CHU de Grenoble - La Tronche - Hôpital A. Michallon (Grenoble, France)
Centre Antoine Lacassagne (Nice, France)
Centre Antoine Lacassagne (Nice, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
Hopital De Jolimont (Haine St Paul, Belgium)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Leiden University Medical Centre (Leiden, Netherlands)
Maastro Clinic - Maastricht Radiation Oncology (Maastricht, Netherlands)
Medisch Centrum Haaglanden - Westeinde (Den Haag, Netherlands)
Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium)
Radiotherapiegroep Arnhem (Arnhem, Netherlands)
Radiotherapiegroep Deventer (Deventer, Netherlands)
Reinier De Graaf Gasthuis (Delft, Netherlands)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
Universitair Ziekenhuis Brussel (Brussels, Belgium)
University Medical Center Groningen (Groningen, Netherlands)
ZNA Middelheim (Antwerpen, Belgium)
Centers to be activated Erasmus MC (Rotterdam, Netherlands)
Isala Klinieken (Zwolle, Netherlands)
Protocol summary http://clinicaltrials.gov/ct/show/NCT00470236
NCT number NCT00470236