Study

EORTC-18081-MG

Adjuvant peginterferon alpha-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group

Study documentation Back to result

Trial Status

LT-FU ongoing

Dates

Date of activation: 23-Oct-2012
Date Step1 close: 25-Jan-2017
Date Step2 close: 24-Jan-2017

Data management at EORTC

Yes

Design

Phase 3
Randomized open label

Targeted Sample size

EORTC Groups: 1200 - All Groups: 1200

Treatment

Drug
Peginterferon alfa-2b

Study Staff

Sandrine Marreaud (Clinical Research Physician), EORTC Headquarters, Brussels
Ellen Peeters (Clinical Operations Manager), EORTC Headquarters, Brussels
Sven Janssen (Data Manager), EORTC Headquarters, Brussels
Leen Wijnen (Data Manager), EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager), EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels

Type of cancer

Melanoma

Participating groups

EORTC Melanoma Group
NCIC Clinical Trial Group

Recruiting centers

APHP - Univ Paris Saclay - Hopital Ambroise Pare (Boulogne Billancourt, France)
APHP Hop Univ Paris Seine-Saint-Denis- Hop Avicenne (Bobigny, France)
APHP Nord - Univ De Paris Cite - Hop. Bichat- Claude Bernard (Paris, France)
APHP Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France)
Aarhus University Hospital (Aarhus, Denmark)
Amsterdam UMC stichting - locatie VUMC (Amsterdam, Netherlands)
Azienda Sanitaria Universitaria Friuli Centrale (Ospedaliero Universitario "Santa Maria della Misericordia" ) (Udine, Italy)
CHU Amiens Picardie - Site Sud (Amiens, France)
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (BORDEAUX CEDEX, France)
CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France)
CHU de Lille (LILLE CEDEX, France)
CHU de Nice - Hopital De L'Archet (NICE, France)
CHU de Reims - Hopital Robert Debre (REIMS CEDEX, France)
Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
Centre Hospitalier De Pau (PAU CEDEX, France)
Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom)
Gustave Roussy (VILLEJUIF CEDEX, France)
Herlev Hospital - University Copenhagen (Herlev, Denmark)
Hopital de La Timone (APHM) (MARSEILLE, France)
Hospital Clinic de Barcelona (Barcelona, Spain)
Hospital Distrital De Santarem (Santarem, Portugal)
Hospital Universitario 12 De Octubre (Madrid, Spain)
IRCCS - Fondazione G. Pascale (Napoli, Italy)
IRCCS - Istituto Tumori "Giovanni Paolo II" (Bari, Italy)
Institut Jules Bordet (Anderlecht, Belgium)
Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal)
Istituto Dermopatico Dell'Immacolata (Roma, Italy)
Istituto Europeo di Oncologia (Milano, Italy)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
Leiden University Medical Centre (Leiden, Netherlands)
Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
Medical University of Graz - Dermatology (Graz, Austria)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
Norfolk And Norwich Hospital (Norwich, United Kingdom)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Odense University Hospital (Odense C, Denmark)
St George's University Hospital NHS Trust Foundation (London, United Kingdom)
St Helens & Knowsley NHS Trust - Whiston Hospital (Prescot - Merseyside, United Kingdom)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UHB- Selly Oak Hospital (Birmingham, United Kingdom)
UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom)
UniversitaetsMedizin Mannheim (Mannheim, Germany)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinikum - Essen (Essen, Germany)
Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik (Heidelberg, Germany)
Universitaetsklinikum Koeln (Koeln, Germany)
Universitaetsklinikum Schleswig-Holstein - Campus Kiel-Klinik Dermatologie, Venerologie und Allergologie (Kiel, Germany)
Universitaetsklinikum Wuerzburg (Wuerzburg, Germany)
University Hospital Graz (Graz, Austria)
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital (Southampton, United Kingdom)

Protocol summary

http://clinicaltrials.gov/study/NCT01502696

NCT number

NCT01502696

EudraCT

2009-010273-20