Melanoma Clinical Trial
Official title:
Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma
The aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. Patients are randomly assigned to either observation only or interferon treatment for 2 different durations. The outcome with respect to overall survival, relapse-free survival, side effects and quality of life is analysed.
This is an open multicenter, prospective randomised phase III trial evaluating the efficacy
of two different schedules of Interferon-alpha2b (IFN-alpha2b) administered in an adjuvant
setting after adequate surgery in high risk cutaneous melanoma patients (T4N0M0/TxN1-2M0).
The patients have been operated for either a thick primary melanoma (> 4 mm) without
evidence of distant metastasis or have undergone surgery for regional lymph node metastases.
The study consists of a control arm (A) and two treatment arms, B and C. The outcome in arms
B and C with adjuvant treatment with IFN-alpha2b will be compared to the outcome of arm A in
which the patients will only be observed after the surgery. The primary endpoint is overall
survival. Secondary endpoints are relapse-free survival, safety-toxicity and health-related
quality of life.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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