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

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).

Conditions

• Glioblastoma
• High-grade Glioma
• Glioblastoma, IDH-wildtype
• Glioblastoma, IDH-mutant
• Glioblastoma Multiforme, Adult
• Astrocytoma, Grade IV
• Astrocytoma, Grade III
• Astrocytoma, Malignant
• Brain Neoplasms
• Brain Neoplasm, Primary
• Brain Neoplasms, Adult
• Brain Neoplasm, Malignant

Interventions

PROCEDURE

Supramaximal resection

Supramaximal resection. Tumor resection continues until either the FLAIR abnormalities have been resected based on the neuronavigation (after updating the navigation intraoperatively), or when subcortical tracts are identified with intraoperative stimulation.

PROCEDURE

Maximal safe resection

Maximal safe resection. Tumor resection continues until maximal safe resection has been achieved as by the neurosurgeon's opinion.

Sponsors & Collaborators

• Haaglanden Medical Centre

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• University Hospital Heidelberg

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Jasper Gerritsen

  lead OTHER

Principal Investigators

• Jasper Gerritsen, MD PhD · Erasmus Medical Center

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2027-01-01

Completion

2028-01-01

Countries

• United States
• Belgium
• Germany
• Netherlands
• Switzerland

Study Locations