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Brief Title: Trial in Low Grade Glioma Patients: Wait or Treat
Official Title: IDH Mutated 1p/19q Intact Lower Grade Glioma Following Resection: Wait Or Treat? IWOT - a Phase III Study
Study ID: NCT03763422
Brief Summary: The 1635-EORTC-BTG study - Wait or Treat - concerns patients that represent a clinically favorable group of patients with IDHmutated astrocytoma (oligo-symptomatic), without a need for immediate post-operative treatment. It will establish whether early adjuvant treatment with radiotherapy and adjuvant temozolomide in resected IDHmutated astrocytoma will improve outcome, and whether benefits of early treatment outweigh potential side-effects of that, such as deterioration in neurocognitive function or Quality of Live, seizure activity and Patient Reported outcome compared to active surveillance.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Princess Alexandra Hospital - University of Queensland, Woolloongabba, Brisbane, QLD, Australia
Prince of Wales Hospital, Randwick - Sydney, New South Wales, Australia
Westmead Hospital - Crown Princess Mary Cancer Centre, Westmead, New South Wales, Australia
Illawarra Cancer Care Centre - Wollongong Hospital, Wollongong, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Monash Medical Centre, Clayton, Victoria, Australia
St Vincent's Hospital, Fitzroy (Melbourne), Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, West-Australia, Australia
Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH uniklinieken, Vienna, , Austria
Onze Lieve Vrouw Ziekenhuis, Aalst, , Belgium
Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus, Wilrijk, , Belgium
Aarhus University Hospitals - Aarhus University Hospital-Skejby, Aarhus, , Denmark
CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer, Bron, , France
CHRU de Lille, Lille, , France
Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (APHM), Marseille, , France
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere, Paris, , France
Institut de Cancerologie Strasbourg Europe (formar Paul Strauss), Strasbourg, , France
AUSL Bologna - Ospedale Bellaria, Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Istituto Clinico Humanitas, Milano, , Italy
IRCCS - Istituto Neurologico Carlo Besta, Milano, , Italy
IRCCS - Istituto Oncologico Veneto, Padova, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze, Torino, , Italy
Catharina Ziekenhuis, Eindhoven, , Netherlands
Leiden University Medical Centre, Leiden, , Netherlands
Haaglanden Medisch Centrum (HMC) - Haaglanden MC - locatie Antoniushove, Leidschendam, , Netherlands
Maastro Clinic - Maastricht Radiation Oncology, Maastricht, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
ETZ Tilburg - St. Elisabethziekenhuis TweeSteden, Tilburg, , Netherlands
UMC-Academisch Ziekenhuis Utrecht, Utrecht, , Netherlands
Hospital Clinic Universitari de Barcelona, Barcelona, , Spain
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals, Barcelona, , Spain
Institut Catala d'Oncologia - Hospital Germans Trias i Pujol, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario 12 De Octubre, Madrid, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Oncology Institute of Southern Switzerland (IOSI), Bellinzona, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
UniversitaetsSpital Zurich, Zürich, , Switzerland
NHS Tayside - Ninewells Hospital, Dundee, Scotland, United Kingdom
NHS Lothian - Western General Hospital, Edinburgh, , United Kingdom
Clatterbridge Centre for Oncology NHS Trust - Clatterbridge NHS -Wirral, Wirral, , United Kingdom
Name: Martin Van den Bent
Affiliation: EORTC Study Coordinator
Role: PRINCIPAL_INVESTIGATOR