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Surgery in Treating Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Study NCT00002860   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 29, 2009   History of Changes

November 1, 1999
July 29, 2009
November 1996
 
Overall survival [ Designated as safety issue: No ]
Overall survival
Complete list of historical versions of study NCT00002860 on ClinicalTrials.gov Archive Site
 
 
 
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.

Phase II
Interventional
Treatment
Melanoma (Skin)
Procedure: conventional surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
 
 

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, SWOG-9430, ECOG-S9430
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 UPMC Cancer Centers
National Cancer Institute (NCI)
December 2005

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