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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorJasper Gerritsen

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

784 Participants
are divided into 2 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