Expired Study
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Tucson, Arizona 85724


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000065130


NCT ID:

NCT00002860


Secondary ID:

U10CA032102


Study Acronym:


Brief Title:

SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma


Official Title:

A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southwest Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

77


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jeffrey A. Sosman, MD
Study Chair
Vanderbilt-Ingram Cancer Center

Study Dates

Start Date:November 1996
Completion Date:December 2010
Completion Type:Actual
Primary Completion Date:December 2006
Primary Completion Type:Actual
Verification Date:January 2012
Last Changed Date:January 11, 2012
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Overall survival
Time Frame:1-year
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Surgery
Description:Complete surgical resection of metastatic melanoma
Arm Name:surgery

Study Arms

Study Arm Type:Other
Arm Name:surgery

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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