Astrocytoma, Grade II

Astrocytoma, Grade III

Oligodendroglioma

Oligodendroglioma, Anaplastic

Erasmus MC

Amsterdam UMC

HollandPTC

Leiden University Medical Center

Haaglanden Medical Center

Radiotherapy in IDH Mutated Glioma: Evaluation of Late Outcomes

The Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 displays Grade 1 to 5, ranging from 'mild' to 'death'. The case report form will include a predefined set of CTCAE items of expected radiotherapy related toxicities. In addition, other CTCAE toxicities grade ≥ 2 that are likely, possibly or definitely related to the radiotherapy should be recorded in the case report form (CRF), when they occur. All items will include a causality assessment: likely or definitely attributable to radiotherapy, unrelated or unlikely attributable to radiotherapy, or not assessable.

Neurocognitive functioning will be assessed with a standard and well established short neuropsychological test battery, developed for use in clinical trials. The following tests are included: Hopkins Verbal Learning Test (HVLT), Trail Making Test part A and B (TMT A/B), Controlled Oral Word Association (COWA), Medical Outcomes Study Cognitive Functioning Scale (MOS), Diagnostic Instrument for Mild Aphasia (DIMA)

NIFS is defined as time from first irradiation to date of initiation of further treatment after radio- and/or chemotherapy or death (any cause), whichever occurs first.

PFS is defined as the time from first irradiation to progressive disease, according to (any of) the Response Asessment in Neuro Oncology (RANO) criteria for progressive disease in low grade glioma.

OS is defined as time from first irradiation to date of death from any cause.

HRQoL will be assessed with the EORTC quality of life questionnaire (QLQ-C30) supplemented by the neuro-oncological module (QLQ-BN20) and the Euro Quality of Life questionnaire (EQ5D-5L)

For the Health Related Economics (HR-E) analyses, the EQ5D - 5L questionnaire will be used in conjunction with the Productivity Costs Questionnaire (iPCQ) and the Medical Consumption Questionnaire (iMCQ). These questionaires are optional.

If feasible, pre- and 4 months post-treatment a scan protocol will be used that, besides the standard clinical imaging, will focus on (micro-)structural and microvascular characteristics that could predict neurocognitive outcome and treatment efficacy. This feasibility is site-specific.

Alejandra Mendez Romero

MD, PhD

Erasmus Medical Center

Amsterdam University Medical Center

Delft University of Technology

Medical Center Haaglanden

Radiotherapy and concurrent temozolomide chemotherapy

Radiotherapy plus adjuvant temozolomide chemotherapy

Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy

Brain and Central Nervous System Tumors

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

temozolomide

MGMT methylation status is used for stratification at randomization.

DNA methylation analysis

laboratory biomarker analysis

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

adjuvant therapy

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

quality-of-life assessment

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

radiation therapy

Arizona Oncology Services Foundation

Cedars-Sinai Medical Center

UCSF University of California San Francisco Medical Center-Mount Zion

University of Florida

Mayo Clinic in Florida

Florida Hospital

Emory University

Memorial Health University Medical Center

Northwestern University

Loyola University Medical Center

Oncology Associates PC

Parkview Hospital

Saint Vincent Oncology Center

McFarland Clinic

June E. Nylen Cancer Center

Via Christi Regional Medical Center

Wesley Medical Center

Maine Medical Center

Boston Medical Center

Brigham and Women's Hospital

Massachussets General Hospital Cancer Center

Saint Joseph Mercy Hospital

Henry Ford Hospital

West Michigan Cancer Center

St John's Mercy Medical Center

Methodist Estabrook Cancer Center

Dartmouth Hitchcock Medical Center

State University of New York Upstate Medical University

Highland Hospital

University of Rochester - James P. Wilmot Cancer Center

Carolinas Medical Center

Akron City Hospital - Summa Health System

Summa Barberton Hospital

Cleveland Clinic Foundation

MetroHealth Medical Center

Western Reserve University

Ohio State University Medical Center

Southwest General Health Center Ireland Cancer Center

UHHS-Chagrin Highlands Medical Center

Cancer Care Center, Incorporated

UHHS - Westlake Medical Center

Cancer Treatment Center

Abington Memorial Hospital

Lehigh Valley Hospital

UPMC - Heritage Valley Health System - The Medical Center

Penn State M.S. Hershey Medical Center

Thomas Jefferson University Hospital

Reading Hospital and Medical Center

Medical University of South Carolina

Cancer Centers of the Carolinas - Eastside

Cancer Centers of the Carolinas - Faris Road

Cancer Centers of the Carolinas - Greer Radiation Oncology

Cancer Centers of the Carolinas - Seneca

Spartanburg Regional Medical Center

Rapid City Regional Hospital

University of Texas Medical Branch

Md Anderson Cancer Center

Methodist Hospital

Intermountain Medical Center

Utah Valley Regional Medical Center

Dixie Medical Center Regional Cancer Center

LDS Hospital

University Of Utah - Huntsman Cancer Institute

Virginia Commonwealth University

Swedish Cancer Institute

Virginia Mason CCOP

Saint Mary's Hospital

Saint Vincent Hospital

Gundersen Lutheran

University Of Wisconsin Comprehensive Cancer Center

Froedtert and the Medical College of Wisconsin

Waukesha Memorial Hospital

Royal North Shore Hospital

Royal Prince Alfred Hospital

Princess Alexandra Hospital

Royal Melbourne Hospital

Flinders Medical Centre

St Vincent'S Hospital

Austin-Repatriation Medical Centre

Royal Hobart Hospital

Sir Charles Gairdner Hospital

Alfred Hospital

ZNA Middelheim

Cliniques Universitaires St. Luc

Universitair Ziekenhuis Brussel

Clinique Notre-Dame

Algemeen Ziekenhuis Sint Lucas

U.Z. Gasthuisberg

Tom Baker Cancer Centre

London Regional Cancer Center

Allan Blair Cancer Centre

University Health Network - Oci / Princess Margaret Hospital

Cancercare Manitoba

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

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

Centre Antoine Lacassagne

Chu Pitie-Salpetriere AP-HP

Centre Eugene Marquis

Institut Gustave Roussy

Klinikum Bamberg

Phase III Trial of Anaplastic Glioma Without 1p/19q LOH

Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

isocitrate dehydrogenase/atrophy

Radiotherapy in IDH Mutated Glioma: Evaluation of Late Outcomes

Phase III Trial of Anaplastic Glioma Without 1p/19q LOH

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