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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| 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: | Treatment, Randomized, Active Control |
| 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
Hide Study Locations| Austria | |
| Krankenhaus der Elisabethinen | |
| Linz, Austria, 4020 | |
| Belgium | |
| Clinique Notre Dame de Grace | |
| Gosselies, Belgium, 6041 | |
| Hopital Universitaire Erasme | |
| Brussels, Belgium, 1070 | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Czech Republic | |
| Onkologicka Klinka A Onkologicka Lab | |
| Prague, Czech Republic, 128 08 | |
| France | |
| Centre Eugene Marquis | |
| Rennes, France, 35042 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| CHU Ambroise Pare | |
| Boulogne Billancourt, France, F-92104 | |
| CHU de Bordeaux - Hopital Pellegrin | |
| Bordeaux, France, 33076 | |
| Hopital L'Archet - 2 | |
| Nice, France, F-06202 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Germany | |
| Haematologisch-Onkologische Praxis Altona | |
| Hamburg, Germany, D-22765 | |
| Federal Armed Forces Hospital of Ulm - Department of Dermatology | |
| Blaustein, Germany, D-89134 | |
| Georg August Universitaet | |
| Goettingen, Germany, D-37075 | |
| Eberhard Karls Universitaet | |
| Tuebingen, Germany, D-72076 | |
| III Medizinische Klinik Mannheim | |
| Mannheim, Germany, D-68305 | |
| Universitaet Wuerzburg/Hautkrankheiten | |
| Wuerzburg, Germany, D-97080 | |
| Universitaets - Augenklinik - Erlangen | |
| Erlangen, Germany, D-91054 | |
| Universitaetsklinikum Benjamin Franklin | |
| Berlin, Germany, D-12200 | |
| Italy | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa (Genova), Italy, 16132 | |
| Netherlands | |
| Erasmus University Medical Center | |
| Rotterdam, Netherlands, 3075 EA | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Norway | |
| Norwegian Radium Hospital | |
| Oslo, Norway, N-0310 | |
| Portugal | |
| Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa | |
| Lisbon, Portugal, 1093 | |
| Switzerland | |
| UniversitaetsSpital | |
| Zurich, Switzerland, CH-8091 | |
| United Kingdom, England | |
| Addenbrooke's NHS Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Christie Hospital N.H.S. Trust | |
| Manchester, England, United Kingdom, M20 9BX | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Weston Park Hospital | |
| Manchester, England, United Kingdom, M20 9BX | |
| Southend NHS Trust Hospital | |
| Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
| St. James's Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Royal Marsden NHS Trust | |
| London, England, United Kingdom, SW3 6JJ | |
| Study Chair: | Juergen C. Becker, MD, PhD | Universitaets-Hautklinik Wuerzburg |
More Information
| Study ID Numbers: | CDR0000068723, EORTC-18981 |
| Study First Received: | July 11, 2001 |
| Last Updated: | August 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020839 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma recurrent melanoma tumors metastatic to brain |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Temozolomide Pharmacologic Actions Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms Neoplastic Processes Pathologic Processes Therapeutic Uses Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |