Interferon Alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the Groin
A Prospective Randomized Phase III Clinical Trial Assessing the Role of Post-Operative Radiotherapy Plus Adjuvant Interferon Alpha-2b in Patients With Cervical, Axillary, and Inguinal Nodal Metastasis From Cutaneous Melanoma
Sponsor: Eastern Cooperative Oncology Group
This PHASE3 trial investigates Melanoma (Skin) and is currently completed. Eastern Cooperative Oncology Group leads this study, which shows 7 recorded versions since 1999 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)OBJECTIVES: I. Evaluate the effectiveness of postoperative hypofractionated radiotherapy in combination with high dose interferon in preventing regional relapse in patients with malignant melanoma with any number of nodes with clinical extracapsular extension or previous nodal basin recurrence. II. Evaluate the effectiveness of this therapy in prolonging relapse free and overall survival in this patient population. III. Evaluate the toxicity of this therapy in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to prior nodal basin recurrence, site of disease, and extracapsular extension. Following surgery, patients are randomized to receive either interferon alfa-2b alone or five treatments of radiotherapy followed by interferon alfa-2b. Patients receive radiotherapy 2 days a week for 2.5 weeks. Patients receive interferon alfa-2b IV over 20 minutes daily for 5 days for a total of 28 days, followed by subcutaneous injections 3 times a week for 48 weeks. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 167 patients will be accrued for this study within 3 years.
OBJECTIVES: I. Evaluate the effectiveness of postoperative hypofractionated radiotherapy in combination with high dose interferon in preventing regional relapse in patients with malignant melanoma with any number of nodes with clinical extracapsular extension or previous nodal basin recurrence. II. Evaluate the effectiveness of this therapy in prolonging relapse free and overall survival in this patient population. III. Evaluate the toxicity of this therapy in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to prior nodal basin recurrence, site of disease, and extracapsular extension. Following surgery, patients are randomized to receive either interferon alfa-2b alone or five treatments of radiotherapy followed by interferon alfa-2b. Patients receive radiotherapy 2 days a week for 2.5 weeks. Patients receive interferon alfa-2b IV over 20 minutes daily for 5 days for a total of 28 days, followed by subcutaneous injections 3 times a week for 48 weeks. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 167 patients will be accrued for this study within 3 years.
Status Flow
Change History
7 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jul 2023 — Jul 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2023 [monthly]
Completed PHASE3
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 2 earlier versions
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Mar 1999
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Eastern Cooperative Oncology Group
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .