Study

EORTC-22922-10925-ROG-BCG

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)

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), ZAS Augustinus (previous GZA), Wilrijk
  • Walter Van den Bogaert (Study Coordinator), U.Z. Leuven - Campus Gasthuisberg, Leuven
  • Catherine Fortpied (Statistician), EORTC Headquarters, Brussels
  • Lydia Champezou (Fellow), EORTC Headquarters, Brussels
  • Katheline Vander Heggen (Regulatory Affairs Administrator), 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)
  • Azienda Socio Sanitaria Territoriale Lariana (Ospedale Sant Anna) (Como, Italy)
  • 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)
  • Centre Eugene Marquis (RENNES CEDEX, France)
  • Centre Georges-Francois-Leclerc (DIJON CEDEX, France)
  • Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
  • Centre Leon Berard (Lyon, France)
  • Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany)
  • Cliniques Universitaires Saint-Luc (Brussels, 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)
  • 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)
  • Universitaetsklinikum - Essen (Essen, Germany)
  • Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
  • ZAS Augustinus (previous GZA) (Wilrijk, Belgium)

Protocol summary

NCT number

NCT00002851