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Phase III randomized trial investigating the role of internal mammary and medial supraclavicular (IM-MS) lymph node chain irradiation in stage I-III breast cancer (Joint study of the EORTC Radiotherapy Cooperative Group and the EORTC Breast Cancer Cooperative Group EORTC 22922/10925)

Study documentation

Trial Status LT-FU ongoing
Dates Date of activation: 23-Jul-1996
Date Step1 close: 15-Jan-2004
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 3780
Treatment Radiotherapy
Study Staff Harry Bartelink (Study Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam
Alain Fourquet (Study Coordinator) , Institut Curie- Hopital de Paris, PARIS CEDEX 05
Philip Poortmans (Study Coordinator) , GasthuisZusters Antwerpen - Sint-Augustinus, Wilrijk
Walter Van den Bogaert (Study Coordinator) , U.Z. Leuven - Campus Gasthuisberg, Leuven
Laura De Meulemeester (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels
Julie Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Bette Stofs (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Type of cancer Breast
Participating groups EORTC Breast Cancer Group
EORTC Radiation Oncology Group
Centers to be activated APHP - Hop. Univ. Henri Mondor (Creteil, France)
AZ Groeninge – Oncology Centre (Kortrijk, Belgium)
Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France)
Centre Antoine Lacassagne (NICE CEDEX 2, France)
Centre Eugene Marquis (RENNES CEDEX, France)
Centre Georges-Francois-Leclerc (DIJON CEDEX, France)
Centre Leon Berard (Lyon, France)
Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
Gustave Roussy (VILLEJUIF CEDEX, France)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
Institut Curie- Hopital de Paris (PARIS CEDEX 05, France)
Instituut Verbeeten (Tilburg, Netherlands)
Medical University Of Gdansk (Gdansk, Poland)
Medisch Spectrum Twente (Enschede, Netherlands)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Ospedale Sant Anna (Como, Italy)
Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
Tergooiziekenhuizen - location Blaricum (Blaricum, Netherlands)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands)
UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands)
Universitaetsklinikum - Essen (Essen, Germany)
Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
Protocol summary
NCT number NCT00002851
Financial Support EORTC HQ