Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Surgery in Treating Patients With Metastatic Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	SWOG-9430 ECOG-S9430, NCT00002860

Objectives

1. Assess overall and progression-free survival in patients with metastatic melanoma (beyond the draining lymph nodes) after complete surgical resection of all known disease.
2. 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.

Entry Criteria

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

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

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

Expected Enrollment

A total of 100 eligible patients with completely surgically resected disease will be accrued for this study.

Outcomes

Overall survival

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.

Sondak VK, Liu PY, Warneke J, et al.: Surgical resection for stage IV melanoma: a Southwest Oncology Group trial (S9430). [Abstract] J Clin Oncol 24 (Suppl 18): A-8019, 457s, 2006.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Jeffrey Sosman, MD, Protocol chair		Ph: 615-322-4967; 800-811-8480 Email: jeff.sosman@vanderbilt.edu

Eastern Cooperative Oncology Group

John Kirkwood, MD, Protocol chair		Ph: 412-692-4724

Registry Information
Official Title		A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up
Trial Start Date		1996-11-15
Registered in ClinicalTrials.gov		NCT00002860
Date Submitted to PDQ		1996-11-15
Information Last Verified		2005-12-01
NCI Grant/Contract Number		U10-CA32102

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