Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

751

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

September 5, 2018

Study Completion Date

December 31, 2029

Conditions
Brain and Central Nervous System Tumors
Interventions
DRUG

temozolomide

Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.

GENETIC

DNA methylation analysis

O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.

OTHER

laboratory biomarker analysis

Prognostic factor analyses

PROCEDURE

adjuvant therapy

Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.

PROCEDURE

quality-of-life assessment

Quality of Life analysis will also be used to assess neurological deterioration free progression

RADIATION

radiation therapy

Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

Trial Locations (132)

2050

Royal Prince Alfred Hospital, Sydney

2065

Royal North Shore Hospital, St Leonards

3050

Royal Melbourne Hospital, Parkville

4102

Princess Alexandra Hospital, Brisbane

50010

McFarland Clinic, Ames

Unknown

Arizona Oncology Services Foundation, Phoenix

Cedars-Sinai Medical Center, Los Angeles

UCSF University of California San Francisco Medical Center-Mount Zion, San Francisco

University of Florida, Gainesville

Mayo Clinic in Florida, Jacksonville

Florida Hospital, Orlando

Emory University, Atlanta

Memorial Health University Medical Center, Savannah

Northwestern University, Chicago

Loyola University Medical Center, Maywood

Oncology Associates PC, Fort Wayne

Parkview Hospital, Fort Wayne

Saint Vincent Oncology Center, Indianapolis

June E. Nylen Cancer Center, Sioux City

Via Christi Regional Medical Center, Wichita

Wesley Medical Center, Wichita

Maine Medical Center, Scarborough

Boston Medical Center, Boston

Brigham and Women's Hospital, Boston

Massachussets General Hospital Cancer Center, Boston

Saint Joseph Mercy Hospital, Ann Arbor

Henry Ford Hospital, Detroit

West Michigan Cancer Center, Kalamazoo

St John's Mercy Medical Center, St Louis

Methodist Estabrook Cancer Center, Omaha

Dartmouth Hitchcock Medical Center, Lebanon

State University of New York Upstate Medical University, New York

Highland Hospital, Rochester

University of Rochester - James P. Wilmot Cancer Center, Rochester

Carolinas Medical Center, Charlotte

Akron City Hospital - Summa Health System, Akron

Summa Barberton Hospital, Barberton

Cleveland Clinic Foundation, Cleveland

MetroHealth Medical Center, Cleveland

Western Reserve University, Cleveland

Ohio State University Medical Center, Columbus

Southwest General Health Center Ireland Cancer Center, Middleburg Heights

UHHS-Chagrin Highlands Medical Center, Orange

Cancer Care Center, Incorporated, Salem

UHHS - Westlake Medical Center, Westlake

Cancer Treatment Center, Wooster

Abington Memorial Hospital, Abington

Lehigh Valley Hospital, Allentown

UPMC - Heritage Valley Health System - The Medical Center, Beaver

Penn State M.S. Hershey Medical Center, Hershey

Thomas Jefferson University Hospital, Philadelphia

Reading Hospital and Medical Center, West Reading

Medical University of South Carolina, Charleston

Cancer Centers of the Carolinas - Eastside, Greenville

Cancer Centers of the Carolinas - Faris Road, Greenville

Cancer Centers of the Carolinas - Greer Radiation Oncology, Greer

Cancer Centers of the Carolinas - Seneca, Seneca

Spartanburg Regional Medical Center, Spartanburg

Rapid City Regional Hospital, Rapid City

University of Texas Medical Branch, Galveston

Md Anderson Cancer Center, Houston

Methodist Hospital, Houston

Intermountain Medical Center, Murray

Utah Valley Regional Medical Center, Provo

LDS Hospital, Salt Lake City

University Of Utah - Huntsman Cancer Institute, Salt Lake City

Dixie Medical Center Regional Cancer Center, St. George

Virginia Commonwealth University, Richmond

Swedish Cancer Institute, Seattle

Virginia Mason CCOP, Seattle

Saint Mary's Hospital, Green Bay

Saint Vincent Hospital, Green Bay

Gundersen Lutheran, La Crosse

University Of Wisconsin Comprehensive Cancer Center, Madison

Froedtert and the Medical College of Wisconsin, Milwaukee

Waukesha Memorial Hospital, Waukesha

Flinders Medical Centre, Bedford Park

Austin-Repatriation Medical Centre, Heidelberg

Royal Hobart Hospital, Hobart

St Vincent'S Hospital, Melbourne

Sir Charles Gairdner Hospital, Nedlands

Alfred Hospital, Prahran

ZNA Middelheim, Antwerp

Cliniques Universitaires St. Luc, Brussels

Universitair Ziekenhuis Brussel, Brussels

Clinique Notre-Dame, Charleroi

Algemeen Ziekenhuis Sint Lucas, Ghent

U.Z. Gasthuisberg, Leuven

Tom Baker Cancer Centre, Calgary

London Regional Cancer Center, London

Allan Blair Cancer Centre, Saskatoon

University Health Network - Oci / Princess Margaret Hospital, Toronto

Cancercare Manitoba, Winnipeg

Assistance Publique - Hôpitaux de Marseille - C.H.U. De La Timone, Marseille

C.H.U. de Nancy - Hopital St Julien, Nancy

Centre Antoine Lacassagne, Nice

Chu Pitie-Salpetriere AP-HP, Paris

Centre Eugene Marquis, Rennes

Institut Gustave Roussy, Villejuif

Klinikum Bamberg, Bamberg

Universitaetsklinikum Bonn, Bonn

Medizinische Hochschule Hannover, Hanover

UniversitaetsKlinikum Heidelberg, Heidelberg

Universitaetskliniken Regensburg, Regensburg

Universitaetsklinikum Tuebingen, Tübingen

Tel Aviv Sourasky Medical Center, Tel Aviv

Ospedale Bellaria, Bologna

Istituto Scientifico H.S. Raffaele, Milan

Azienda Ospedaliera San Giovanni Battista Di Torino-Universita Di Torino, Torino

Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam

Vrije Universiteit Medisch Centrum, Amsterdam

University Medical Center Groningen, Groningen

Maastro Clinic - Maastricht Radiation Oncology, Maastricht

Radboud University Nijmegen Medical Centre, Nijmegen

Erasmus MC - Daniel den Hoed Cancer Center, Rotterdam

Medisch Centrum Haaglanden - Westeinde, The Hague

Hospital Clinic Universitari, Barcelona

ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia), Barcelona

Hopital Cantonal Universitaire De Geneve, Geneva

Universitaetsspital, Zurich

University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre, Bristol

Addenbrookes Hospital, Cambridge

Cheltenham General Hospital, Cheltenham

Western General Hospital, Edinburgh

Royal Devon And Exeter Hospital, Exeter

St. James'S University Hospital, Leeds

Christie NHS Foundation Trust, Manchester

Clatterbridge Centre for Oncology NHS Trust, Metropolitan Borough of Wirral

Nottingham University Hospitals NHS Trust - City Hospital campus, Nottingham

Derriford Hospital, Plymouth

Weston Park Hospital, Sheffield

Royal Marsden Hospital, Sutton

All Listed Sponsors
collaborator

NCIC Clinical Trials Group

NETWORK

collaborator

Radiation Therapy Oncology Group

NETWORK

collaborator

Medical Research Council

OTHER_GOV

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK