SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Procedure: Surgery

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00002860

CDR0000065130

SWOG-9430

ECOG-S9430

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

surgery

Other group

Treatment:

Procedure: Surgery