Ulcerated Melanomas Clinical Trial
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.
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.
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