A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma
- Compare overall survival in patients with stage IV melanoma treated with complete
metastasectomy vs dacarbazine and/or cisplatin.
- 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
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
Richard M. Sherry, MD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|