NCT00006249UnknownPhase 3
PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial
European Organisation for Research and Treatment of Cancer - EORTC104 sites in 9 countries1,258 target enrollmentStarted: June 1, 2000Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 1,258
- Locations
- 104
- Primary Endpoint
- distant-metastasis free-survival (DMFS)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed previously resected stage III primary cutaneous melanoma or unknown primary with regional lymph node involvement
- •N1 disease
- •Microscopic, nonpalpable nodal involvement
- •Primary melanoma of any stage with clinically inapparent N1 regional lymph node metastases (T1-4, N1, M0) detected by elective lymph node dissection or sentinel node biopsy
- •N2 disease
- •Palpable nodal involvement with synchronous primary melanoma or apparent nodal disease after prior excision (any pT, N2, M0)
- •Regional lymph node recurrence at any interval after surgery for primary melanoma of any depth (T1-4, rN2, M0)
- •Complete resection of primary melanoma with adequate surgical margins
- •Full lymphadenectomy must be performed within 70 days of study
- •No mucous membrane melanoma or ocular melanoma
- •No evidence of distant or nonregional lymph node metastases or in transit metastases (even if previously resected)
- •No incompletely resected disease due to gross extracapsular extension
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •SGOT and SGPT less than 2 times upper limit of normal
- •No active hepatitis
- •Creatinine less than 2.0 mg/dL
- •Cardiovascular:
- •No severe cardiovascular disease including the following:
- •Arrhythmias requiring chronic treatment
- •Congestive heart failure (New York Heart Association class III or IV)
- •Symptomatic ischemic heart disease
- •No other prior malignancy within the past 5 years except surgically cured nonmelanomatous skin cancer or carcinoma in situ of the cervix
- •No thyroid dysfunction unresponsive to therapy
- •No uncontrolled diabetes mellitus
- •No active autoimmune disease
- •No active and/or uncontrolled infection
- •No history of neuropsychiatric disorder requiring hospitalization
- •No known active alcohol or drug abuse
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior interferon alfa
- •No prior immunotherapy for melanoma
- •No other concurrent immunologic or biologic therapy
- •No concurrent colony stimulating factors including epoetin alfa and filgrastim (G-CSF)
- •Chemotherapy:
- •No prior chemotherapy for melanoma
- •No concurrent chemotherapy
- •Endocrine therapy:
- +10 more not shown
Exclusion Criteria
- Not provided
Arms & Interventions
observation
No Intervention
5 years observation + 5 years follow up
pegylated interferon alfa
Experimental
5 years pegylated interferon alfa + 5 years follow up
Intervention: pegylated interferon alfa (Biological)
pegylated interferon alfa
Experimental
5 years pegylated interferon alfa + 5 years follow up
Intervention: adjuvant therapy (Procedure)
Outcomes
Primary Outcomes
distant-metastasis free-survival (DMFS)
Time Frame: from randomization
distant-metastasis free-survival (DMFS) after randomization
Secondary Outcomes
- toxicity(from randomization)
- survival(from randomization till death)
Investigators
Study Sites (104)
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