SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00002860|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 13, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Procedure: Surgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up|
|Study Start Date :||November 1996|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2010|
Complete surgical resection of metastatic melanoma
- Overall survival [ Time Frame: 1-year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002860
|Study Chair:||Jeffrey A. Sosman, MD||Vanderbilt-Ingram Cancer Center|
|Study Chair:||John M. Kirkwood, MD||University of Pittsburgh|