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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Brain and Central Nervous System Tumors
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Radiation: radiation therapy; Drug: temozolomide; Procedure: adjuvant therapy; Genetic: DNA methylation analysis

Detailed Description

OBJECTIVES:

Primary

• To assess whether concurrent radiotherapy with daily temozolomide improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma.
• To assess whether adjuvant temozolomide improves survival as compared to no adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma.

Secondary

• To assess whether concurrent and adjuvant temozolomide prolongs progression-free survival and neurological deterioration-free survival in patients with non-1p/19q deleted anaplastic glioma.
• To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma, including late effects on cognition.
• To assess the impact of concurrent and adjuvant temozolomide on the quality of life of patients with non-1p/19q deleted anaplastic glioma.

OUTLINE: This is a multicenter study. Patients are stratified according to institution, World Health Organization (WHO) performance status (0 vs > 0), age (≤ 50 vs > 50), presence of 1p LOH only (yes vs no), presence of oligodendroglial elements (yes vs no), and O6-methylguanine-DNA methyltransferase promoter methylation status (methylated vs unmethylated vs indeterminate). Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients undergo radiotherapy* once daily, 5 days a week, for 6.5 weeks (total of 33 fractions).
• Arm II: Patients undergo radiotherapy* once daily, 5 days a week and receive oral temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy).
• Arm III: Patients undergo radiotherapy* once daily, 5 days a week for 6.5 weeks (total of 33 fractions). Beginning 4 weeks after completion of radiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses.
• Arm IV: Patients undergo radiotherapy* once daily, 5 days a week and receive oral temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy). Beginning 4 weeks after completion of radiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses.
• Patients must begin radiotherapy within 8 days after randomization and within 7 weeks after surgery.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaires, including EORTC core quality of life questionnaire (QLQ-C30) version 3, EORTC brain cancer module (BCM20), and the Mini Mental Status Exam at baseline, 4 weeks after the completion of radiotherapy, and then every 3 months for 5 years.

Tissue samples are collected at baseline for histology review, 1p/19q analysis, methylation status of the O6-methylguanine-DNA methyltransferase promoter, and isocitrate dehydrogenase mutation analysis.

After completion of study treatment, patients are followed every 3 months.

• Study Type: Interventional
• Enrollment (Actual): 751
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Bedford Park, Australia
    • Flinders Medical Centre
  • Heidelberg, Australia
    • Austin-Repatriation Medical Centre
  • Hobart, Australia
    • Royal Hobart Hospital
  • Melbourne, Australia
    • St Vincent's Hospital
  • Nedlands, Australia
    • Sir Charles Gairdner Hospital
  • Prahran, Australia
    • Alfred Hospital
  • New South Wales
    • St. Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
    • Sydney, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
• Belgium
  • Antwerpen, Belgium
    • ZNA Middelheim
  • Brussels, Belgium
    • Universitair Ziekenhuis Brussel
  • Brussels, Belgium
    • Cliniques Universitaires St. Luc
  • Charleroi, Belgium
    • Clinique Notre-Dame
  • Gent, Belgium
    • Algemeen Ziekenhuis Sint Lucas
  • Leuven, Belgium
    • U.Z. Gasthuisberg
• Canada
  • Calgary, Canada
    • Tom Baker Cancer Centre
  • London, Canada
    • London Regional Cancer Center
  • Saskatoon, Canada
    • Allan Blair Cancer Centre
  • Toronto, Canada
    • University Health Network - Oci / Princess Margaret Hospital
  • Winnipeg, Canada
    • CancerCare Manitoba
• France
  • Marseille, France
    • Assistance Publique - Hôpitaux de Marseille - C.H.U. De La Timone
  • Nancy, France
    • C.H.U. de Nancy - Hopital St Julien
  • Nice, France
    • Centre Antoine Lacassagne
  • Paris, France
    • Chu Pitie-Salpetriere AP-HP
  • Rennes, France
    • Centre Eugène Marquis
  • Villejuif, France
    • Institut Gustave Roussy
• Germany
  • Bamberg, Germany
    • Klinikum Bamberg
  • Bonn, Germany
    • Universitaetsklinikum Bonn
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany
    • Universitaetsklinikum Heidelberg
  • Regensburg, Germany
    • Universitaetskliniken Regensburg
  • Tuebingen, Germany
    • Universitaetsklinikum Tuebingen
• Israel
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bologna, Italy
    • Ospedale Bellaria
  • Milano, Italy
    • Istituto Scientifico H.S. Raffaele
  • Torino, Italy
    • Azienda Ospedaliera San Giovanni Battista Di Torino-Universita Di Torino
• Netherlands
  • Amsterdam, Netherlands
    • Academisch Medisch Centrum - Universiteit van Amsterdam
  • Amsterdam, Netherlands
    • Vrije Universiteit Medisch Centrum
  • Den Haag, Netherlands
    • Medisch Centrum Haaglanden - Westeinde
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Maastricht, Netherlands
    • Maastro Clinic - Maastricht Radiation Oncology
  • Nijmegen, Netherlands
    • Radboud University Nijmegen Medical Centre
  • Rotterdam, Netherlands
    • Erasmus MC - Daniel den Hoed Cancer Center
• Spain
  • Barcelona, Spain
    • Hospital Clinic Universitari
  • Barcelona, Spain
    • ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
• Switzerland
  • Geneve, Switzerland
    • Hôpital Cantonal Universitaire de Genève
  • Zurich, Switzerland
    • UniversitaetsSpital
• United Kingdom
  • Bristol, United Kingdom
    • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
  • Cambridge, United Kingdom
    • Addenbrookes Hospital
  • Cheltenham, United Kingdom
    • Cheltenham General Hospital
  • Edinburgh, United Kingdom
    • Western General Hospital
  • Exeter, United Kingdom
    • Royal Devon and Exeter Hospital
  • Leeds, United Kingdom
    • St. James's University Hospital
  • Manchester, United Kingdom
    • Christie NHS Foundation Trust
  • Nottingham, United Kingdom
    • Nottingham University Hospitals NHS Trust - City Hospital campus
  • Plymouth, United Kingdom
    • Derriford Hospital
  • Sheffield, United Kingdom
    • Weston Park Hospital
  • Sutton, United Kingdom
    • Royal Marsden Hospital
  • Wirral, United Kingdom
    • Clatterbridge Centre for Oncology NHS Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States
      • Arizona Oncology Services Foundation
  • California
    • Los Angeles, California, United States
      • Cedars-Sinai Medical Center
    • San Francisco, California, United States
      • UCSF University of California San Francisco Medical Center-Mount Zion
  • Florida
    • Gainesville, Florida, United States
      • University of Florida
    • Jacksonville, Florida, United States
      • Mayo Clinic in Florida
    • Orlando, Florida, United States
      • Florida Hospital
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University
    • Savannah, Georgia, United States
      • Memorial Health University Medical Center
  • Illinois
    • Chicago, Illinois, United States
      • Northwestern University
    • Maywood, Illinois, United States
      • Loyola University Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States
      • Parkview Hospital
    • Fort Wayne, Indiana, United States
      • Oncology Associates PC
    • Indianapolis, Indiana, United States
      • Saint Vincent Oncology Center
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic
    • Sioux City, Iowa, United States
      • June E. Nylen Cancer Center
  • Kansas
    • Wichita, Kansas, United States
      • Via Christi Regional Medical Center
    • Wichita, Kansas, United States
      • Wesley Medical Center
  • Maine
    • Scarborough, Maine, United States
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States
      • Boston Medical Center
    • Boston, Massachusetts, United States
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States
      • Massachussets General Hospital Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States
      • Saint Joseph Mercy Hospital
    • Detroit, Michigan, United States
      • Henry Ford Hospital
    • Kalamazoo, Michigan, United States
      • West Michigan Cancer Center
  • Missouri
    • Saint Louis, Missouri, United States
      • St John's Mercy Medical Center
  • Nebraska
    • Omaha, Nebraska, United States
      • Methodist Estabrook Cancer Center
  • New Hampshire
    • Lebanon, New Hampshire, United States
      • Dartmouth Hitchcock Medical Center
  • New York
    • New York, New York, United States
      • State University of New York Upstate Medical University
    • Rochester, New York, United States
      • Highland Hospital
    • Rochester, New York, United States
      • University of Rochester - James P. Wilmot Cancer Center
  • North Carolina
    • Charlotte, North Carolina, United States
      • Carolinas Medical Center
  • Ohio
    • Akron, Ohio, United States
      • Akron City Hospital - Summa Health System
    • Barberton, Ohio, United States
      • Summa Barberton Hospital
    • Cleveland, Ohio, United States
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States
      • Western Reserve University
    • Columbus, Ohio, United States
      • Ohio State University Medical Center
    • Middleburg Heights, Ohio, United States
      • Southwest General Health Center Ireland Cancer Center
    • Orange Village, Ohio, United States
      • UHHS-Chagrin Highlands Medical Center
    • Salem, Ohio, United States
      • Cancer Care Center, Incorporated
    • Westlake, Ohio, United States
      • UHHS - Westlake Medical Center
    • Wooster, Ohio, United States
      • Cancer Treatment Center
  • Pennsylvania
    • Abington, Pennsylvania, United States
      • Abington Memorial Hospital
    • Allentown, Pennsylvania, United States
      • Lehigh Valley Hospital
    • Beaver, Pennsylvania, United States
      • UPMC - Heritage Valley Health System - The Medical Center
    • Hershey, Pennsylvania, United States
      • Penn State M.S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States
      • Thomas Jefferson University Hospital
    • West Reading, Pennsylvania, United States
      • Reading Hospital and Medical Center
  • South Carolina
    • Charleston, South Carolina, United States
      • Medical University of South Carolina
    • Greenville, South Carolina, United States
      • Cancer Centers of the Carolinas - Eastside
    • Greenville, South Carolina, United States
      • Cancer Centers of the Carolinas - Faris Road
    • Greer, South Carolina, United States
      • Cancer Centers of the Carolinas - Greer Radiation Oncology
    • Seneca, South Carolina, United States
      • Cancer Centers of the Carolinas - Seneca
    • Spartanburg, South Carolina, United States
      • Spartanburg Regional Medical Center
  • South Dakota
    • Rapid City, South Dakota, United States
      • Rapid City Regional Hospital
  • Texas
    • Galveston, Texas, United States
      • University of Texas Medical Branch
    • Houston, Texas, United States
      • MD Anderson Cancer Center
    • Houston, Texas, United States
      • Methodist Hospital
  • Utah
    • Murray, Utah, United States
      • Intermountain Medical Center
    • Provo, Utah, United States
      • Utah Valley Regional Medical Center
    • Saint George, Utah, United States
      • Dixie Medical Center Regional Cancer Center
    • Salt Lake City, Utah, United States
      • LDS Hospital
    • Salt Lake City, Utah, United States
      • University of Utah - Huntsman Cancer Institute
  • Virginia
    • Richmond, Virginia, United States
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States
      • Swedish Cancer Institute
    • Seattle, Washington, United States
      • Virginia Mason CCOP
  • Wisconsin
    • Green Bay, Wisconsin, United States
      • Saint Mary's Hospital
    • Green Bay, Wisconsin, United States
      • Saint Vincent Hospital
    • La Crosse, Wisconsin, United States
      • Gundersen Lutheran
    • Madison, Wisconsin, United States
      • University of Wisconsin Comprehensive Cancer Center
    • Milwaukee, Wisconsin, United States
      • Froedtert and the Medical College of Wisconsin
    • Waukesha, Wisconsin, United States
      • Waukesha Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:

  • Anaplastic oligodendroglioma
  • Anaplastic oligoastrocytoma
  • Anaplastic astrocytoma
• Newly diagnosed disease
• Prior surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
• Absence of combined 1p/19q loss
• Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA methyltransferase promoter methylation status assessment, isocitrate dehydrogenase mutation analysis, and central pathology review
• Patients must be on a stable or decreasing dose of steroids for at least two weeks prior to randomization

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9 cells/L
• Platelet count ≥ 100 x 10^9 cells/L
• Bilirubin < 1.5 x upper limit of normal (ULN)
• Alkaline phosphatase < 2.5 x ULN
• Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 x ULN
• Serum creatinine < 1.5 x ULN
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No known HIV infection or chronic hepatitis B or hepatitis C infection
• No other serious medical condition that would interfere with follow-up
• No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction)
• No other prior malignancies except for any malignancy which was treated with curative intent more than 5 years prior to registration and adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
• No prior or concurrent malignancies at other sites except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
• No psychological, familial, sociological, or geographical condition that would potentially hamper compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy, including carmustine-containing wafers (Gliadel®)
• No prior radiotherapy to the brain
• No concurrent growth factors unless vital for the patient
• No other concurrent investigational treatment
• No other concurrent anticancer agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RT & Concurrent CT; Radiotherapy and concurrent temozolomide chemotherapy	Other: laboratory biomarker analysis; Prognostic factor analyses; 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; Drug: temozolomide; Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.; Other Names: Temodar; Temodal; Genetic: DNA methylation analysis; O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.
Active Comparator: RT + Adjuvant CT; Radiotherapy plus adjuvant temozolomide chemotherapy	Other: laboratory biomarker analysis; Prognostic factor analyses; 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; Drug: temozolomide; Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.; Other Names: Temodar; Temodal; Procedure: adjuvant therapy; Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.; Genetic: DNA methylation analysis; O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.
Active Comparator: RT & Concurrent CT + adjuvant CT; Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy	Other: laboratory biomarker analysis; Prognostic factor analyses; 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; Drug: temozolomide; Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.; Other Names: Temodar; Temodal; Procedure: adjuvant therapy; Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.; Genetic: DNA methylation analysis; O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.
Active Comparator: Radiotherapy (RT) alone; radiation therapy alone	Other: laboratory biomarker analysis; Prognostic factor analyses; 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; Genetic: DNA methylation analysis; O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival	Disease progression is defined as radiological or neurological/clinical progression (whichever occurs first); progression free survival (PFS) is the time interval between the date of randomization and the date of disease progression or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination. Radiological progression was defined as increase of contrast enhancing area on MRI or CT scans of more than 25% as measured by two perpendicular diameters compared to the smallest measurements ever recorded for the same lesion by the same technique. The appearance of new lesions with or without contrast enhancement Neurological/clinical progression was defined as:decrease in WHO performance status,deterioration of neurological functions,appearance of signs/symptoms of increased intracranial pressure,and/or start of corticosteroid or increase of corticosteroid dosage by 50% for control of neurological symptoms.	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	Quality of life was assessed by the EORTC Quality of Life Questionnaire (QLQ-C30) version 3 and the Brain Cancer Module-20	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	Neurological deterioration is defined as a decrease in WHO performance status as follows: decrease in WHO performance status; for patients with baseline WHO performance status 0: deterioration to WHO performance status 2 or worse for which no other explanation is present, and which is maintained for at least three months; for patients with baseline WHO performance status 1 or 2: deterioration to WHO performance status 3 or worse for which no other explanation is present and which is maintained for at least three months The date of neurological deterioration will be the first date the persistent decrease in performance status was diagnosed. Neurological deterioration free progression is the time interval between the date of randomization and the date of neurological deterioration or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination	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.

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Merck Sharp & Dohme LLC; Medical Research Council; NCIC Clinical Trials Group; Radiation Therapy Oncology Group
• Investigators: Study Chair: Michael A. Vogelbaum, MD, PhD, The Cleveland Clinic; Study Chair: Warren P. Mason, MD, Princess Margaret Hospital, Canada; Study Chair: S. Erridge, Medical Research Council; Study Chair: Anna Nowak, MD, Sir Charles Gairdner Hospital - Nedlands; Study Chair: Wolfgang Wick, Universitatsklinikum Heidelberg

Publications and helpful links

General Publications

• Tesileanu 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.
• van 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.
• van 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. Erratum In: Lancet. 2017 Oct 7;390(10103):1644.

Helpful Links

• Clinical trial summary from the EORTC database

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2007
• Primary Completion (Actual): September 5, 2018
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: February 28, 2008
• First Submitted That Met QC Criteria: February 28, 2008
• First Posted (Estimated): February 29, 2008

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: adult anaplastic astrocytoma; adult anaplastic oligodendroglioma
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: EORTC-26053-22054; NCIC CTG CEC.1 (Other Identifier: NCI-C); RTOG-0834 (Other Identifier: RTOG); 2006-001533-17 (EudraCT Number); P04839 (Other Grant/Funding Number: Merck); MRC BR14 (Other Identifier: MRC CTU)