The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB. A total of 880 will be randomized up to three months after first surgical management of their melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
901
Arbeitsgemeinschaft Dermatologische Onkologie, Skin Cancer Program, Department of Dermatology, University of Tübingen
Tübingen, Baden-Wurttemberg, Germany
Time to distant metastasis
Time frame: From date of randomization until the date of first documented distant metastases or date of death from any cause, whichever came first, assessed up to 60 months
Disease free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Quality of life
Time frame: Measured at different visits (week 0, week 12, month 3, month 6)
Number and Grade of Adverse Events
Time frame: Measured at every visit (week 4, week 8, week 12, month 3, month 6 and every 3 months during therapy)
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