Melanoma (Skin) Clinical Trial
Official title:
A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma
RATIONALE: Drugs used in chemotherapy, such as dacarbazine and cisplatin, work in different
ways to stop tumor cells from dividing so they stop growing or die. Complete metastasectomy
may be an effective treatment for metastatic melanoma and may improve quality of life and
help patients live longer and more comfortably. It is not yet known whether complete
metastasectomy is more effective than chemotherapy in treating stage IV melanoma.
PURPOSE: This randomized phase III trial is studying dacarbazine and/or cisplatin to see how
well they work compared to complete metastasectomy in treating patients with stage IV
melanoma.
OBJECTIVES:
Primary
- Compare overall survival in patients with stage IV melanoma treated with complete
metastasectomy vs dacarbazine and/or cisplatin.
Secondary
- Compare time to progression in patients treated with these regimens.
- Determine the response rate in patients treated with dacarbazine and/or cisplatin.
- Compare the morbidity and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to prior exposure to
dacarbazine and cisplatin (yes vs no) and number of sites of metastases (1 vs 2 or more).
Patients are randomized to 1 of 2 treatment arms.
- Arm I (surgery): Patients undergo complete metastasectomy. Patients with disease
progression after surgery may undergo repeat resection or may receive dacarbazine
and/or cisplatin as in arm II.
- Arm II (systemic therapy): Patients receive dacarbazine IV over 30-60 minutes and/or
cisplatin IV over 30 minutes on days 1, 2, 3, 22, 23, and 24 (1 course). Courses repeat
every 42 days in the absence of disease progression or unacceptable toxicity. Patients
achieving a complete response (CR) receive at least 1 additional course of chemotherapy
beyond CR and are eligible for other investigational strategies.
Quality of life is assessed at baseline, at 3 and 6 months, and at 1 year.
Patients are followed every 3-4 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 74 patients (37 per treatment arm) will be accrued for this
study within 4 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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