The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
View:

• Age ≥18 years and ≤90 years

• Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon

• Written informed consent

Locations
United States
California
University of California, San Francisco (UCSF)
RECRUITING
San Francisco
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Other Locations
Belgium
University Hospitals Leuven
RECRUITING
Leuven
Germany
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Technical University Munich
NOT_YET_RECRUITING
Munich
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Haaglanden Medical Centre
RECRUITING
The Hague
Switzerland
Inselspital Universitätsspital Bern
NOT_YET_RECRUITING
Bern
Contact Information
Primary
Jasper Gerritsen, MD PhD
j.gerritsen@erasmusmc.nl
+31107036130
Backup
Arnaud Vincent, MD PhD
a.vincent@erasmusmc.nl
+31107034211
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 784
Treatments
Supramaximal resection
Supramaximal resection: maximal resection of the contrast-enhancing and non-contrast-enhancing part of the tumor (FLAIRectomy)
Maximal safe resection
Maximal safe resection of the contrast-enhancing part of the tumor
Sponsors
Leads: Jasper Gerritsen
Collaborators: Massachusetts General Hospital, Universitaire Ziekenhuizen KU Leuven, Insel Gruppe AG, University Hospital Bern, Technical University of Munich, University of California, San Francisco, Haaglanden Medical Centre, University Hospital Heidelberg

This content was sourced from clinicaltrials.gov