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Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma. PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.
Official title: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
751
Start Date
2007-12
Completion Date
2029-12
Last Updated
2023-09-11
Healthy Volunteers
No
Conditions
Interventions
temozolomide
Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis
O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.
laboratory biomarker analysis
Prognostic factor analyses
adjuvant therapy
Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment
Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy
Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
Locations (132)
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCSF University of California San Francisco Medical Center-Mount Zion
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Florida Hospital
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Oncology Associates PC
Fort Wayne, Indiana, United States
Parkview Hospital
Fort Wayne, Indiana, United States
Saint Vincent Oncology Center
Indianapolis, Indiana, United States
McFarland Clinic
Ames, Iowa, United States
June E. Nylen Cancer Center
Sioux City, Iowa, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Maine Medical Center
Scarborough, Maine, United States
Boston Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachussets General Hospital Cancer Center
Boston, Massachusetts, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
St John's Mercy Medical Center
St Louis, Missouri, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
State University of New York Upstate Medical University
New York, New York, United States
Highland Hospital
Rochester, New York, United States
University of Rochester - James P. Wilmot Cancer Center
Rochester, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Akron City Hospital - Summa Health System
Akron, Ohio, United States
Summa Barberton Hospital
Barberton, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Western Reserve University
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States
UHHS-Chagrin Highlands Medical Center
Orange, Ohio, United States
Cancer Care Center, Incorporated
Salem, Ohio, United States
UHHS - Westlake Medical Center
Westlake, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
UPMC - Heritage Valley Health System - The Medical Center
Beaver, Pennsylvania, United States
Penn State M.S. Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Greer Radiation Oncology
Greer, South Carolina, United States
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
University of Texas Medical Branch
Galveston, Texas, United States
Md Anderson Cancer Center
Houston, Texas, United States
Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
University Of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Virginia Mason CCOP
Seattle, Washington, United States
Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran
La Crosse, Wisconsin, United States
University Of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Flinders Medical Centre
Bedford Park, Australia
Austin-Repatriation Medical Centre
Heidelberg, Australia
Royal Hobart Hospital
Hobart, Australia
St Vincent'S Hospital
Melbourne, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
Alfred Hospital
Prahran, Australia
ZNA Middelheim
Antwerp, Belgium
Cliniques Universitaires St. Luc
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Clinique Notre-Dame
Charleroi, Belgium
Algemeen Ziekenhuis Sint Lucas
Ghent, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
Tom Baker Cancer Centre
Calgary, Canada
London Regional Cancer Center
London, Canada
Allan Blair Cancer Centre
Saskatoon, Canada
University Health Network - Oci / Princess Margaret Hospital
Toronto, Canada
Cancercare Manitoba
Winnipeg, Canada
Assistance Publique - Hôpitaux de Marseille - C.H.U. De La Timone
Marseille, France
C.H.U. de Nancy - Hopital St Julien
Nancy, France
Centre Antoine Lacassagne
Nice, France
Chu Pitie-Salpetriere AP-HP
Paris, France
Centre Eugene Marquis
Rennes, France
Institut Gustave Roussy
Villejuif, France
Klinikum Bamberg
Bamberg, Germany
Universitaetsklinikum Bonn
Bonn, Germany
Medizinische Hochschule Hannover
Hanover, Germany
UniversitaetsKlinikum Heidelberg
Heidelberg, Germany
Universitaetskliniken Regensburg
Regensburg, Germany
Universitaetsklinikum Tuebingen
Tübingen, Germany
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Ospedale Bellaria
Bologna, Italy
Istituto Scientifico H.S. Raffaele
Milan, Italy
Azienda Ospedaliera San Giovanni Battista Di Torino-Universita Di Torino
Torino, Italy
Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam, Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Maastro Clinic - Maastricht Radiation Oncology
Maastricht, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Erasmus MC - Daniel den Hoed Cancer Center
Rotterdam, Netherlands
Medisch Centrum Haaglanden - Westeinde
The Hague, Netherlands
Hospital Clinic Universitari
Barcelona, Spain
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
Barcelona, Spain
Hopital Cantonal Universitaire De Geneve
Geneva, Switzerland
Universitaetsspital
Zurich, Switzerland
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Cheltenham General Hospital
Cheltenham, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Royal Devon And Exeter Hospital
Exeter, United Kingdom
St. James'S University Hospital
Leeds, United Kingdom
Christie NHS Foundation Trust
Manchester, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Metropolitan Borough of Wirral, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital campus
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom