Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00002860
First received: November 1, 1999
Last updated: January 11, 2012
Last verified: January 2012

November 1, 1999
January 11, 2012
November 1996
December 2006   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 1-year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002860 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma
A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
Procedure: Surgery
Complete surgical resection of metastatic melanoma
surgery
Intervention: Procedure: Surgery
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
December 2010
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002860
CDR0000065130, U10CA032102, SWOG-9430, ECOG-S9430
No
Southwest Oncology Group
Southwest Oncology Group
  • National Cancer Institute (NCI)
  • Eastern Cooperative Oncology Group
Study Chair: Jeffrey A. Sosman, MD Vanderbilt-Ingram Cancer Center
Study Chair: John M. Kirkwood, MD University of Pittsburgh
Southwest Oncology Group
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP