Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma
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
All registered deaths, not only melanoma-specific.
Evaluated at regular intervals: every 3 months for 2 years, every 6 months up to 5 years and yearly up to 10 years following randomization. Actual median follow-up is 72.4 months
Johan Hansson, MD,PhD
Karolinska Institutet, Stockholm, Sweden
Sweden: Medical Products Agency