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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072124 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Drug: cisplatin Drug: dacarbazine Procedure: conventional surgery |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma |
| Study Start Date: | September 2003 |
OBJECTIVES:
Primary
Secondary
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.
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of metastatic melanoma
Metastatic disease amenable to complete surgical resection
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Richard M. Sherry, MD | NCI - Surgery Branch |
More Information
| Study ID Numbers: | CDR0000335471, NCI-03-C-0279 |
| Study First Received: | November 4, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00072124 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma recurrent melanoma |
|
Neoplasms by Histologic Type Dacarbazine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Pharmacologic Actions Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Cisplatin Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |