SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma
RATIONALE: Surgery may be effective therapy in treating patients with metastatic melanoma.
PURPOSE: This phase II trial is studying how well surgery works in treating patients with metastatic melanoma.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up|
- Overall survival [ Time Frame: 1-year ] [ Designated as safety issue: No ]
|Study Start Date:||November 1996|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Complete surgical resection of metastatic melanoma
- Assess overall and progression-free survival in patients with metastatic melanoma (beyond the draining lymph nodes) after complete surgical resection of all known disease.
- Determine the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with metastatic melanoma who can be resected to a disease-free state.
OUTLINE: This is a multicenter study.
All patients undergo gross total resection of all known disease. Patients whose disease cannot be completely resected or who have disease recurrence after surgery are removed from study. Patients found to have microscopic residual disease after surgery are considered completely resected. Resected tissue is submitted for analysis on protocol SWOG-9431.
Patients may receive any adjuvant therapy (e.g., radiotherapy, interferon, and/or vaccines) deemed clinically appropriate by the treating physician.
Patients are followed periodically for 5 years after study entry.
PROJECTED ACCRUAL: A total of 100 eligible patients with completely surgically resected disease will be accrued for this study.
Show 124 Study Locations
|Study Chair:||Jeffrey A. Sosman, MD||Vanderbilt-Ingram Cancer Center|
|Study Chair:||John M. Kirkwood, MD||University of Pittsburgh|