About this trial
A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively.
This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively.
The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).
Eligibility criteria
Qualifiers
Age ≥18 years and ≤90 years
Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
Written informed consent
Disqualifiers
Tumors of the cerebellum, brainstem or midline
Multifocal contrast enhancing lesions
Medical reasons precluding MRI (e.g. pacemaker)
Inability to give written informed consent
Trial design
Treatments tested in this trial
- Supramaximal resection
- Maximal safe resection
Treatment groups
Sponsors and collaborators
Jasper Gerritsen
Lead sponsor
Erasmus Medical Center
Sponsor institution
Haaglanden Medical Centre
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
University Hospital Heidelberg
Collaborator
Technical University of Munich
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Massachusetts General Hospital
Collaborator
University of California, San Francisco
Collaborator