Clinical Trial Details

EORTC-10981-22023-BCG-ROG

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After Mapping of the Axilla:Radiotherapy Or Surgery AMAROS

Study documentation

Trial Status LT-FU ongoing
Dates Date of activation: 15-Feb-2001
Date Step1 close: 30-Apr-2010
Date Step2 close: 08-Jun-2010
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 3485
Treatment Radiotherapy, Surgery
Study Staff Emiel Rutgers (Study Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam
Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Laura De Meulemeester (Clinical Operations Manager) , EORTC Headquarters, Brussels
Mila Donker (Study Co-Coordinator) , Leiden University Medical Centre, Leiden
Catherine Hermans (Data Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Diem Chi Nguyen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Coralie Poncet (Statistician) , EORTC Headquarters, Brussels
Cornelis Van De Velde (Study Co-Coordinator) , Leiden University Medical Centre, Leiden
Geertjan Van Tienhoven (Study Co-Coordinator) , Amsterdam UMC - Locatie AMC, Amsterdam
Type of cancer Breast
Participating groups EORTC Breast Cancer Group
EORTC Radiation Oncology Group
Borstkanker Onderzoeksgroup Nederland
ALMANAC Trialists Group
Centers to be activated Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
Assistance Publique - Hopitaux de Paris - CHU Henri Mondor (Creteil, France)
Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
CHU de Grenoble - La Tronche - Hopital A. Michallon (Grenoble, France)
Catharina Ziekenhuis (Eindhoven, Netherlands)
Centre Oscar Lambret (Lille, France)
Gelre Ziekenhuizen - Lukas Locatie (Apeldoorn, Netherlands)
Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
HagaZiekenhuis - locatie Sportlaan ('S Gravenhage - Den Haag, Netherlands)
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
Laurentius Ziekenhuis Roermond (Roermond, Netherlands)
Leiden University Medical Centre (Leiden, Netherlands)
Medical University Of Gdansk (Gdansk, Poland)
Nevill Hall Hospital (Abergavenny, United Kingdom)
Nij Smellinghe (Drachten, Netherlands)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Rambam Health Care Campus, Oncology Institute (Haifa, Israel)
Reinier De Graaf Gasthuis (Delft, Netherlands)
Rijnstate Hospital (Arnhem, Netherlands)
Ropcke Zweers Ziekenhuis (Hardenberg, Netherlands)
Royal Gwent Hospital (Newport, South Wales, United Kingdom)
Russels Hall Hospital (Dudley, United Kingdom)
S.B. Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi (Istanbul, Turkey)
Spaarne Gasthuis Haarlem Zuid (Haarlem, Netherlands)
The Institute Of Oncology (Ljubljana, Slovenia)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
University College London Medical School (London, United Kingdom)
University Medical Center Groningen (Groningen, Netherlands)
Wythenshawe Hospital (MFT) (Wythenshawe, Manchester, United Kingdom)
Ziekenhuis Amstelland (Amstelveen, Netherlands)
Ziekenhuis Bronovo (Den Haag, Netherlands)
Ziekenhuis St Jansdal (Harderwijk, Netherlands)
Protocol summary http://clinicaltrials.gov/ct/show/NCT00014612
NCT number NCT00014612
Financial Support EORTC HQ