Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
CATNON
Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
6 other identifiers
interventional
751
12 countries
132
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2007
Longer than P75 for phase_3
132 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2018
CompletedResults Posted
Study results publicly available
September 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
ExpectedSeptember 11, 2023
August 1, 2023
10.8 years
February 28, 2008
February 14, 2023
August 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival as Measured From the Day of Randomization
The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.
from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)
Secondary Outcomes (3)
Progression-free Survival
from randomization till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study)
Quality of Life of the Patient
from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study)
Neurological Deterioration Free Survival
within 2 weeks of randomization; during radiotherapy at week 4 and 6; 4 weeks after the end of radiotherapy; Six monthly after the end of radiotherapy; Prior to each cycle of adjuvant therapy; Every six months after the documentation of first progression.
Study Arms (4)
Radiotherapy (RT) alone
ACTIVE COMPARATORradiation therapy alone
RT & Concurrent CT
ACTIVE COMPARATORRadiotherapy and concurrent temozolomide chemotherapy
RT + Adjuvant CT
ACTIVE COMPARATORRadiotherapy plus adjuvant temozolomide chemotherapy
RT & Concurrent CT + adjuvant CT
ACTIVE COMPARATORRadiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
Interventions
Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.
Prognostic factor analyses
Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
Quality of Life analysis will also be used to assess neurological deterioration free progression
Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- European Organisation for Research and Treatment of Cancer - EORTClead
- NCIC Clinical Trials Groupcollaborator
- Radiation Therapy Oncology Groupcollaborator
- Medical Research Councilcollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (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, 50010, 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, 2065, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, 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
Related Publications (4)
van den Bent MJ, Ghisai SA, Wick W, Sanson M, Brandes AA, Clement PM, Erridge SC, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Tabouret E, Gill S, Griffin M, Taal W, Ruda R, Weller M, McBain C, Reijneveld JC, Enting RH, Tran S, Lesimple T, Kocher M, Gijtenbeek A, Lim E, Herrlinger U, Hau P, Dhermain F, Aldape K, Jenkins RB, Dubbink HJ, Kros JM, Wesseling P, Hoogstrate Y, Nuyens S, Golfinopoulos V, Tesileanu CMS, Gorlia T, French P, Baumert BG. Concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma (CATNON; EORTC study 26053-22054): final and exploratory analyses of a randomised, open-label, phase 3 trial. Lancet Oncol. 2026 Jan;27(1):45-56. doi: 10.1016/S1470-2045(25)00614-X.
PMID: 41449147DERIVEDTesileanu CMS, Sanson M, Wick W, Brandes AA, Clement PM, Erridge SC, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Ruda R, Weller M, McBain C, van Linde ME, Aldape K, Jenkins RB, Kros JM, Wesseling P, von Deimling A, Hoogstrate Y, de Heer I, Atmodimedjo PN, Dubbink HJ, Brouwer RWW, van IJcken WFJ, Cheung KJ, Golfinopoulos V, Baumert BG, Gorlia T, French PJ, van den Bent MJ. Temozolomide and Radiotherapy versus Radiotherapy Alone in Patients with Glioblastoma, IDH-wildtype: Post Hoc Analysis of the EORTC Randomized Phase III CATNON Trial. Clin Cancer Res. 2022 Jun 13;28(12):2527-2535. doi: 10.1158/1078-0432.CCR-21-4283.
PMID: 35275197DERIVEDvan den Bent MJ, Tesileanu CMS, Wick W, Sanson M, Brandes AA, Clement PM, Erridge S, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Ruda R, Weller M, McBain C, Reijneveld J, Enting RH, Caparrotti F, Lesimple T, Clenton S, Gijtenbeek A, Lim E, Herrlinger U, Hau P, Dhermain F, de Heer I, Aldape K, Jenkins RB, Dubbink HJ, Kros JM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, French P, Baumert BG. Adjuvant and concurrent temozolomide for 1p/19q non-co-deleted anaplastic glioma (CATNON; EORTC study 26053-22054): second interim analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2021 Jun;22(6):813-823. doi: 10.1016/S1470-2045(21)00090-5. Epub 2021 May 14.
PMID: 34000245DERIVEDvan den Bent MJ, Baumert B, Erridge SC, Vogelbaum MA, Nowak AK, Sanson M, Brandes AA, Clement PM, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Brachman DG, Taal W, Ruda R, Weller M, McBain C, Reijneveld J, Enting RH, Weber DC, Lesimple T, Clenton S, Gijtenbeek A, Pascoe S, Herrlinger U, Hau P, Dhermain F, van Heuvel I, Stupp R, Aldape K, Jenkins RB, Dubbink HJ, Dinjens WNM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, Wick W, Kros JM. Interim results from the CATNON trial (EORTC study 26053-22054) of treatment with concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma: a phase 3, randomised, open-label intergroup study. Lancet. 2017 Oct 7;390(10103):1645-1653. doi: 10.1016/S0140-6736(17)31442-3. Epub 2017 Aug 8.
PMID: 28801186DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Thierry Gorlia
- Organization
- EORTC
Study Officials
- STUDY CHAIR
Wolfgang Wick
Universitatsklinikum Heidelberg
- STUDY CHAIR
Warren P. Mason, MD
Princess Margaret Hospital, Canada
- STUDY CHAIR
Michael A. Vogelbaum, MD, PhD
The Cleveland Clinic
- STUDY CHAIR
S. Erridge
Medical Research Council
- STUDY CHAIR
Anna Nowak, MD
Sir Charles Gairdner Hospital - Nedlands
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2008
First Posted
February 29, 2008
Study Start
December 1, 2007
Primary Completion
September 5, 2018
Study Completion (Estimated)
December 1, 2029
Last Updated
September 11, 2023
Results First Posted
September 11, 2023
Record last verified: 2023-08