Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
European Organisation for Research and Treatment of Cancer - EORTC
OBJECTIVES: * Compare the effect of adjuvant therapy with pegylated interferon alfa vs observation, in terms of distant metastases-free survival, in patients with previously resected stage III melanoma. * Compare the overall survival in these patients after treatment with pegylated interferon alfa vs observation. * Determine the toxicity of pegylated interferon alfa in these patients. * Determine the compliance of these patients treated with pegylated interferon alfa. * Compare the quality of life in these patients after treatment with pegylated interferon alfa vs observation. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of nodal involvement (N1 vs N2), number of positive nodes (1 vs 2-4 vs 5 or more vs not assessed), Breslow primary (T1-2 vs T3 vs T4 vs unknown), ulceration of primary tumor (absent vs present vs unknown), sex, and center. Patients are randomized to one of two treatment arms. * Arm I: Patients receive pegylated interferon alfa subcutaneously weekly for 5 years. * Arm II: Patients undergo observation only. Treatment continues in the absence of distant metastases or unacceptable toxicity. Quality of life is assessed at baseline, and then at months 3, 12, 24, 36, 48, and 60. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: A total of 1,200 patients (600 per treatment arm) will be accrued for this study within 1.5-2 years.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
