SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma that is deemed grossly surgically resectable Multiple resected sites or metastatic melanoma of unknown primary allowed provided all known disease can be grossly resected Recurrence in iliac lymph nodes after inguinal lymph dissection allowed No metastatic disease beyond the lesions planned for resection Confirmed by CT scan of chest, abdomen, pelvis, and CT or MRI of brain within 42 days of study Concurrent registration on protocol SWOG-9431 required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which patient is currently disease free Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunotherapy in the adjuvant or metastatic setting allowed Chemotherapy: Prior chemotherapy in the adjuvant or metastatic setting allowed Endocrine therapy: Prior hormonal therapy in the adjuvant or metastatic setting allowed Radiotherapy: Prior radiotherapy in the adjuvant or metastatic setting allowed Surgery: See Disease Characteristics At least 14 days since prior surgery in the adjuvant or metastatic setting Other: Recovered from prior therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: surgery<br> | Procedure: Surgery<br>* Complete surgical resection of metastatic melanoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma