SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma

Phase 2

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00002860
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 1996-11
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-12
• Study Completion: 2010-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-11
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall survival	1-year

Trial Locations

Locations (124)

Alaska Regional Hospital Cancer Center; 🇺🇸 Anchorage, Alaska, United States

Banner Good Samaritan Medical Center; 🇺🇸 Phoenix, Arizona, United States

CCOP - Western Regional, Arizona; 🇺🇸 Phoenix, Arizona, United States

Banner Thunderbird Medical Center; 🇺🇸 Phoenix, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States

North Colorado Medical Center; 🇺🇸 Greeley, Colorado, United States

McKee Medical Center; 🇺🇸 Loveland, Colorado, United States

Baptist Cancer Institute - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Saint Anthony's Hospital at Saint Anthony's Health Center; 🇺🇸 Alton, Illinois, United States

Good Samaritan Regional Health Center; 🇺🇸 Mt. Vernon, Illinois, United States

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