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

(SUPRAMAX Trial)

Recruiting at 7 trial locations

Overseen By Arnaud Vincent, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jasper Gerritsen

Disqualifiers: Cerebellum tumors, Brainstem tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

784 Participants Needed

Trial Summary

What is the purpose of 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).

Research Team

Jasper Gerritsen, MD PhD

Principal Investigator

Erasmus Medical Center

Eligibility Criteria

Inclusion Criteria

You have given written consent.

You have been diagnosed with an High-grade Glioma (WHO Grade III/IV) tumour, as determined by MRI imaging and a neurosurgeon's assessment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either supramaximal or maximal safe resection of the tumor

Immediate

1 visit (in-person)

Postoperative Evaluation

Participants are evaluated for neurological and functional outcomes using NIHSS, MOCA, and other assessments

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety, quality of life, and progression-free survival

6 months

3 visits (in-person) at 6 weeks, 3 months, and 6 months

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival

Up to 5 years

Treatment Details

Participant Groups

Group I: Supramaximal resection Experimental Treatment 1 Intervention

Supramaximal resection: maximal resection of the contrast-enhancing and non-contrast-enhancing part of the tumor (FLAIRectomy)

Group II: Maximal safe resection Experimental Treatment 1 Intervention

Maximal safe resection of the contrast-enhancing part of the tumor

Who Is Running the Clinical Trial?

Jasper Gerritsen

Lead Sponsor

Trials

5

Recruited

3,100+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

University Hospital Heidelberg

Collaborator

Trials

258

Recruited

278,000+

Insel Gruppe AG, University Hospital Bern

Collaborator

Trials

831

Recruited

2,353,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Technical University of Munich

Collaborator

Trials

395

Recruited

813,000+

Universitaire Ziekenhuizen KU Leuven

Collaborator

Trials

1,048

Recruited

1,658,000+

Haaglanden Medical Centre

Collaborator

Trials

18

Recruited

11,200+