Interferon Alfa or No Further Therapy Following Surgery in Treating Patients With Stage II, Stage III, or Recurrent Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00002892
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known whether interferon alfa following surgery is more effective than surgery alone in treating patients with melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with no further therapy following surgery in treating patients with stage II, stage III, or recurrent melanoma.
- Detailed Description
OBJECTIVES: I. Determine the effects of adjuvant low-dose extended-duration interferon alfa on disease-free and overall survival in patients with completely resected malignant melanoma at high risk of recurrence. II. Determine any correlation between patient age or sex and the effects of interferon therapy on disease-free and overall survival. III. Describe the toxic effects of this treatment. IV. Evaluate the economic implications of implementing effective interferon therapy in these patients.
OUTLINE: This is a randomized study. Patients will be stratified by age, sex, disease status at entry, and participating institution. Patients are randomized to observation only or to receive interferon alfa by subcutaneous injections 3 times weekly for 2 years, or until disease progression or toxicity intervenes. Patients are followed monthly for 6 months, quarterly for 18 months, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be entered over 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
University Hospitals of Leicester
🇬🇧Leicester, England, United Kingdom
Royal Free Hospital
🇬🇧Hampstead, London, England, United Kingdom
Guy's, King's and St. Thomas' Hospitals Trust
🇬🇧London, England, United Kingdom
Royal Marsden NHS Trust
🇬🇧London, England, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, United Kingdom
Selly Oak Hospital
🇬🇧Birmingham, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Queen Elizabeth Hospital
🇬🇧King's Lynn, United Kingdom
Southend Hospital
🇬🇧Southend on Sea, United Kingdom
St. James's Hospital
🇬🇧Leeds, England, United Kingdom