SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma - Full Text View

Sponsor:	Southwest Oncology Group
Collaborators:	National Cancer Institute (NCI) Eastern Cooperative Oncology Group
Information provided by (Responsible Party):	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00002860

Purpose

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	Intervention	Phase
Melanoma (Skin)	Procedure: Surgery	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

Overall survival [ Time Frame: 1-year ] [ Designated as safety issue: No ]

Enrollment:	77
Study Start Date:	November 1996
Study Completion Date:	December 2010
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
surgery	Procedure: Surgery Complete surgical resection of 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002860

Show 124 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Investigators

Study Chair:	Jeffrey A. Sosman, MD	Vanderbilt-Ingram Cancer Center
Study Chair:	John M. Kirkwood, MD	University of Pittsburgh

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00002860 History of Changes
Other Study ID Numbers:	CDR0000065130, U10CA032102, SWOG-9430, ECOG-S9430
Study First Received:	November 1, 1999
Last Updated:	January 11, 2012
Health Authority:	United States: Federal Government

Keywords provided by Southwest Oncology Group:

stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on February 12, 2012