314
Participants
Start Date
December 9, 2016
Primary Completion Date
November 30, 2025
Study Completion Date
June 30, 2026
Standard surgery
Intraoperative radiotherapy
Dose to applicator surface: 20-30 Gy; Carl Zeiss INTRABEAM System. IORT with a surface dose of 30 Gy is recommended.Should the proximity to any risk structure not allow to apply 30 Gy, a dose reduction by up to 10 Gy (resulting in a surface dose of 20 Gy) is allowed.
Radiochemotherapy
EBRT to 60 Gy plus 75 mg/m2/d temozolomide
Temozolomide
Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Lenox Hill Hospital, Hofstra Northwell School of Medicine, New York
Long Island Jewish Medical Center, North Shore University Hospital, Lake Success
Charité - Universitätsmedizin, Berlin
Helios University Hospital Wuppertal, Wuppertal
Stritch School of Medicine Loyola University, Maywood
University Hospital Mannheim, Mannheim
Klinikum Stuttgart, Stuttgart
Technical University of Munich (TUM), Department of Radiation Oncology, Munich
Barrow Neurological Institute (SJHMC), Phoenix
University Hospital Augsburg, Augsburg
Beijing Tian Tan Hospital, Capital Medical University, Beijing
West Virginia University, Morgantown
Hospital Alemão Oswaldo Cruz, São Paulo
Montreal Neurological Institute and Hospital, Montreal
St. Georg Hospital, Leipzig
Hospital Reina Sofia, Córdoba
Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul
Catalan Institute of Oncology (ICO), Barcelona
The London Clinic, London
Collaborators (1)
Carl Zeiss Meditec AG
INDUSTRY
University of California, Los Angeles
OTHER
Universitätsmedizin Mannheim
OTHER