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Brief Title: Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
Official Title: A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)
Study ID: NCT02685605
Brief Summary: INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Barrow Neurological Institute (SJHMC), Phoenix, Arizona, United States
Stritch School of Medicine Loyola University, Maywood, Illinois, United States
Long Island Jewish Medical Center, North Shore University Hospital, Lake Success, New York, United States
Lenox Hill Hospital, Hofstra Northwell School of Medicine, New York, New York, United States
West Virginia University, Morgantown, West Virginia, United States
Hospital Alemão Oswaldo Cruz, São Paulo, , Brazil
Montreal Neurological Institute and Hospital, Montréal, Quebec, Canada
Beijing Tian Tan Hospital, Capital Medical University, Beijing, , China
University Hospital Augsburg, Augsburg, , Germany
Charité - Universitätsmedizin, Berlin, , Germany
St. Georg Hospital, Leipzig, , Germany
University Hospital Mannheim, Mannheim, , Germany
Technical University of Munich (TUM), Department of Radiation Oncology, Munich, , Germany
Klinikum Stuttgart, Stuttgart, , Germany
Helios University Hospital Wuppertal, Wuppertal, , Germany
Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, , Korea, Republic of
Catalan Institute of Oncology (ICO), Barcelona, , Spain
Hospital Reina Sofia, Córdoba, , Spain
The London Clinic, London, , United Kingdom
Name: Frank A. Giordano, MD
Affiliation: Department of Radiation Oncology, University Hospital Bonn, Univeristy of Bonn, Bonn, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Kevin Petrecca, MD
Affiliation: Department of Neurosurgery, Montréal Neurological, Institute and Hospital, Montréal, Canada
Role: PRINCIPAL_INVESTIGATOR