Spots Global Cancer Trial Database for Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain
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Trial Identification
Brief Title: Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain
Official Title: Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases
Study ID: NCT00020839
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Krankenhaus der Elisabethinen, Linz, , Austria
Institut Jules Bordet, Brussels, , Belgium
Hopital Universitaire Erasme, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Clinique Notre Dame de Grace, Gosselies, , Belgium
Onkologicka Klinka A Onkologicka Lab, Prague, , Czech Republic
CHU de Bordeaux - Hopital Pellegrin, Bordeaux, , France
CHU Ambroise Pare, Boulogne Billancourt, , France
Centre Hospital Regional Universitaire de Limoges, Limoges, , France
Hopital L'Archet - 2, Nice, , France
Centre Eugene Marquis, Rennes, , France
Institut Gustave Roussy, Villejuif, , France
Universitaetsklinikum Benjamin Franklin, Berlin, , Germany
Federal Armed Forces Hospital of Ulm - Department of Dermatology, Blaustein, , Germany
Universitaets - Augenklinik - Erlangen, Erlangen, , Germany
Georg August Universitaet, Goettingen, , Germany
Haematologisch-Onkologische Praxis Altona, Hamburg, , Germany
III Medizinische Klinik Mannheim, Mannheim, , Germany
Eberhard Karls Universitaet, Tuebingen, , Germany
Universitaet Wuerzburg/Hautkrankheiten, Wuerzburg, , Germany
Istituto Nazionale per la Ricerca sul Cancro, Genoa (Genova), , Italy
University Medical Center Nijmegen, Nijmegen, , Netherlands
Erasmus University Medical Center, Rotterdam, , Netherlands
Norwegian Radium Hospital, Oslo, , Norway
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa, Lisbon, , Portugal
UniversitaetsSpital, Zurich, , Switzerland
Addenbrooke's NHS Trust, Cambridge, England, United Kingdom
St. James's Hospital, Leeds, England, United Kingdom
Royal Marsden NHS Trust, London, England, United Kingdom
Christie Hospital N.H.S. Trust, Manchester, England, United Kingdom
Weston Park Hospital, Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom
Southend NHS Trust Hospital, Westcliff-On-Sea, England, United Kingdom
Contact Details
Name: Juergen C. Becker, MD, PhD
Affiliation: Universitaets-Hautklinik Wuerzburg
Role: STUDY_CHAIR
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