Full Text View
Tabular View
No Study Results Posted
Related Studies
Surgery in Treating Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
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: conventional surgery
Phase II

Study Type: Interventional
Study Design: 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:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 1996
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
Eastern Cooperative Oncology Group
Investigators
Study Chair: Jeffrey A. Sosman, MD Vanderbilt-Ingram Cancer Center
Study Chair: John M. Kirkwood, MD UPMC Cancer Centers
  More Information

Additional Information:
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.

Study ID Numbers: CDR0000065130, SWOG-9430, ECOG-S9430
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002860     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on July 02, 2009