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 locatie Arnhem, Arnhem
Laura De Meulemeester (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Ruxandra Dionisie (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) , 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 Onderzoek Group Nederland
Recruiting centers AZ Groeninge – Oncology Centre (Kortrijk, Belgium)
Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France)
Centre Antoine Lacassagne (NICE CEDEX 2, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
Institut Jules Bordet (Anderlecht, Belgium)
Isala Klinieken Stichting (Zwolle, Netherlands)
Leiden University Medical Centre (Leiden, Netherlands)
Maastro Clinic - Maastricht Radiation Oncology (Maastricht, Netherlands)
Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium)
Radiotherapiegroep Locatie Deventer (Deventer, Netherlands)
Radiotherapiegroep locatie Arnhem (Arnhem, 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)
Protocol summary http://clinicaltrials.gov/study/NCT00470236
NCT number NCT00470236
Financial Support EORTC Group