Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002860
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 13, 2012
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Procedure: Surgery Phase 2

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 1996
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
surgery Procedure: Surgery
Complete surgical resection of metastatic melanoma

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1-year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • SWOG 0-2


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • Prior immunotherapy in the adjuvant or metastatic setting allowed


  • Prior chemotherapy in the adjuvant or metastatic setting allowed

Endocrine therapy:

  • Prior hormonal therapy in the adjuvant or metastatic setting allowed


  • Prior radiotherapy in the adjuvant or metastatic setting allowed


  • See Disease Characteristics
  • At least 14 days since prior surgery in the adjuvant or metastatic setting


  • Recovered from prior therapy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00002860

Show Show 124 study locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Layout table for investigator information
Study Chair: Jeffrey A. Sosman, MD Vanderbilt-Ingram Cancer Center
Study Chair: John M. Kirkwood, MD University of Pittsburgh

Publications of Results:
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.

Layout table for additonal information
Responsible Party: Southwest Oncology Group Identifier: NCT00002860    
Other Study ID Numbers: CDR0000065130
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012
Keywords provided by Southwest Oncology Group:
stage IV melanoma
recurrent melanoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas