A Phase 3 interventional study of temozolomide and radiation therapy in Melanoma (Skin) and Metastatic Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Terminated at 33 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-24.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment
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.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 23 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
This study is terminated, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC