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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020839 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy is more effective with or without radiation therapy in treating brain metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy to the brain in treating patients who have stage IV melanoma with asymptomatic brain metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) Metastatic Cancer |
Drug: temozolomide Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases |
| Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to LDH levels (less than 225 U/L vs 225 U/L or more), concurrent metastases (visceral vs soft tissue), and participating center. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed before beginning each course and then every 4 weeks after completion of study drug.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed unresectable metastatic melanoma
Documented evidence of disease progression defined by 1 of the following conditions:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 33 Study Locations| Study Chair: | Juergen C. Becker, MD, PhD | Universitaets-Hautklinik Wuerzburg |
More Information
| ClinicalTrials.gov Identifier: | NCT00020839 History of Changes |
| Other Study ID Numbers: | CDR0000068723, EORTC-18981 |
| Study First Received: | July 11, 2001 |
| Last Updated: | August 29, 2009 |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma recurrent melanoma tumors metastatic to brain |
|
Melanoma Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |
Neoplastic Processes Pathologic Processes Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |