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

Phase 3

Terminated

• Conditions: Melanoma (Skin); Metastatic Cancer

• Registration Number: NCT00020839
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2001-07-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (33)

Addenbrooke's NHS Trust; 🇬🇧 Cambridge, England, United Kingdom

Royal Marsden NHS Trust; 🇬🇧 London, England, United Kingdom

UniversitaetsSpital; 🇨🇭 Zurich, Switzerland

Weston Park Hospital; 🇬🇧 Manchester, England, United Kingdom

Krankenhaus der Elisabethinen; 🇦🇹 Linz, Austria

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Clinique Notre Dame de Grace; 🇧🇪 Gosselies, Belgium

CHU de Bordeaux - Hopital Pellegrin; 🇫🇷 Bordeaux, France

CHU Ambroise Pare; 🇫🇷 Boulogne Billancourt, France

Centre Hospital Regional Universitaire de Limoges; 🇫🇷 Limoges, France

Universitaets - Augenklinik - Erlangen; 🇩🇪 Erlangen, Germany

Haematologisch-Onkologische Praxis Altona; 🇩🇪 Hamburg, Germany

III Medizinische Klinik Mannheim; 🇩🇪 Mannheim, 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

Centre Eugene Marquis; 🇫🇷 Rennes, France

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Onkologicka Klinka A Onkologicka Lab; 🇨🇿 Prague, Czech Republic

Hopital L'Archet - 2; 🇫🇷 Nice, France

Federal Armed Forces Hospital of Ulm - Department of Dermatology; 🇩🇪 Blaustein, Germany

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Universitaetsklinikum Benjamin Franklin; 🇩🇪 Berlin, Germany

Georg August Universitaet; 🇩🇪 Goettingen, Germany

Eberhard Karls Universitaet; 🇩🇪 Tuebingen, Germany

Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa; 🇵🇹 Lisbon, Portugal

Clatterbridge Centre for Oncology NHS Trust; 🇬🇧 Merseyside, England, United Kingdom

St. James's Hospital; 🇬🇧 Leeds, England, United Kingdom

Christie Hospital N.H.S. Trust; 🇬🇧 Manchester, England, United Kingdom

Southend NHS Trust Hospital; 🇬🇧 Westcliff-On-Sea, England, United Kingdom