Melanoma (Skin) Clinical Trial
Official title:
PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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