Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma
RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma.
PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma.
Biological: pegylated interferon alfa
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial|
- distant-metastasis free-survival (DMFS) [ Time Frame: from randomization ] [ Designated as safety issue: No ]distant-metastasis free-survival (DMFS) after randomization
- survival [ Time Frame: from randomization till death ] [ Designated as safety issue: No ]duration of survival: time from randomization until death, whatever the cause
- toxicity [ Time Frame: from randomization ] [ Designated as safety issue: Yes ]toxicity
- quality of life [ Time Frame: from randomization ] [ Designated as safety issue: No ]Quality of life evaluation
|Study Start Date:||June 2000|
|Primary Completion Date:||August 2003 (Final data collection date for primary outcome measure)|
No Intervention: observation
5 years observation + 5 years follow up
Experimental: pegylated interferon alfa
5 years pegylated interferon alfa + 5 years follow up
|Biological: pegylated interferon alfa Procedure: adjuvant therapy|
- 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.
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|Study Chair:||Alexander M. M. Eggermont, MD, PhD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|