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.
Trial Status | Closed to Patient Entry |
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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 |