Spots Global Cancer Trial Database for Adjuvant PEG Intron in Ulcerated Melanoma
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Trial Identification
Brief Title: Adjuvant PEG Intron in Ulcerated Melanoma
Official Title: Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus 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 ID: NCT01502696
Conditions
Interventions
Study Description
Brief Summary: Patients with an ulcerated melanoma with Breslow \>1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk. The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medical University of Graz, Graz, , Austria
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Gent, Ghent, , Belgium
U.Z. Leuven - Campus Gasthuisberg, Leuven, , Belgium
Aarhus University Hospital, Aarhus, , Denmark
Herlev Hospital - University Copenhagen, Herlev, , Denmark
Odense University Hospital, Odense, , Denmark
Assistance Publique - Hopitaux de Paris - Hopital Avicenne, Bobigny, , France
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre (Bordeaux, France, Bordeaux, , France
CHU de Grenoble - La Tronche - Hôpital A. Michallon, Grenoble, , France
CHRU de Lille, Lille, , France
Centre Leon Berard, Lyon, , France
Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone, Marseille, , France
CHU de Nice - CHU de Nice - Hopital De L'Archet, Nice, , France
Assistance Publique - Hopitaux de Paris - CHU Ambroise Pare, Paris, , France
Assitance Publique - Hopitaux de Paris - Hopital Bichat-Claude Bernard, Paris, , France
Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis, Paris, , France
Institut Gustave Roussy, Paris, , France
Centre Hospitalier De Pau, Pau, , France
CHU de Reims - Hôpital Robert Debré, Reims, , France
CHU d'Amiens - CHU Amiens - Hopital Sud, Salouel, , France
Universitaetsklinikum, Essen, , Germany
Universitaetsklinikum Heidelberg - Hautklinik / Dermatologic Department, Heidelberg, , Germany
Universitaetsklinikum Heidelberg - Hautklinik, Heidelburg, , Germany
Universitaetsklinikum Schleswig-Holstein, Kiel, , Germany
Universitaetsklinikum Koeln, Koeln, , Germany
Medizinische Universitaet Zu Luebeck, Luebeck, , Germany
Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center, Mainz, , Germany
UniversitaetsMedizin Mannheim, Mannheim, , Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
IRCCS - Istituto Tumori "Giovanni Paolo II", Bari, , Italy
Istituto Europeo di Oncologia, Milan, , Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Napoli, , Italy
Istituto Dermopatico Dell'Immacolata, Roma, , Italy
Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine, Udine, , Italy
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Leiden University Medical Centre, Leiden, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw, , Poland
I.P.O. Francisco Gentil - Centro De Lisboa, Lisboa, , Portugal
I.P.O. Francisco Gentil - Centro De Lisboa, Lisboa, , Portugal
Hospital Distrital De Santarem, Santarem, , Portugal
Hospital Clinic Universitari, Barcelona, , Spain
Hospital Universitario 12 De Octubre, Madrid, , Spain
UniversitaetsSpital Zurich, Zurich, , Switzerland
Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust (UHB) - Queen Elisabeth Medical Centre, Birmingham, , United Kingdom
Mid Essex Hospitals - Broomfield Hospital, Broomfield, , United Kingdom
Cambridge University Hospital NHS - Addenbrookes Hospital, Cambridge, , United Kingdom
Cheltenham General Hospital, Cheltenham, , United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital, Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital, Leeds, , United Kingdom
St George's Hospital NHS Trust (6961), London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Norfolk And Norwich Hospital, Norwich, , United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, , United Kingdom
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital, Southampton, , United Kingdom
St Helens and Knowsley Teaching Hospitals, St Helens, , United Kingdom
Contact Details
Name: Alexander Eggermont, MD, PHD
Affiliation: Institut Gustave Roussy, Paris, France
Role: STUDY_CHAIR
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