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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
3µg/kg weekly injections
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
Relapse-free survival (RFS)
Time frame: 6.3 years from first patient in
Occurence of Adverse Events
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.
Time frame: 6.3 years from first patient in
Overall survival (OS)
Time frame: 7.8 years from first patient in
Distant metastases-free survival (DMFS)
Time frame: 7.8 years from first patient in
Quality of life
Time frame: 6 years from from first patient in
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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
...and 48 more locations