NCT00020839

Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain

Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * Compare the efficacy of temozolomide with or without radiotherapy in terms of overall survival in patients with stage IV melanoma with asymptomatic brain metastases. * Compare the time to appearance of neurological symptoms in patients treated with these regimens. * Compare the progression-free survival of patients treated with these regimens. * Compare the quality of life and quality-adjusted survival of patients treated with these regimens. * Compare the toxicity of these regimens in these patients. 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. * Arm I: Patients receive oral temozolomide once daily on days 1-5. Treatment continues every 4 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive temozolomide as in arm I and whole brain radiotherapy on days 8-12 and 15-19 during the first course of chemotherapy. 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.

Conditions

• Melanoma (Skin)
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	temozolomide
RADIATION	radiation therapy

Timeline

• Start date: 2001-04-01
• Primary completion: 2003-05-01
• First posted: 2003-01-27
• Last updated: 2012-09-24

Locations

33 sites across 11 countries: Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Norway, Portugal, Switzerland, United Kingdom