Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003444
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
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
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Interferon alfa-2b may interfere with the growth of cancer cells It is not yet known whether giving radiation therapy with interferon alfa-2b is more effective than giving interferon alfa-2b alone in treating melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus interferon alfa-2b with that of interferon alfa-2b alone in treating patients who have melanoma that has metastasized to lymph nodes in the neck under the arm or in the groin
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus interferon alfa-2b with that of interferon alfa-2b alone in treating patients who have melanoma that has metastasized to lymph nodes in the neck under the arm or in the groin
Detailed Description:
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 25 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
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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E-3697 | None | None | None |