RecruitingNCT06118723

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

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


Sponsor

Jasper Gerritsen

Enrollment

784 participants

Start Date

Jan 1, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study (SUPRAMAX) compares two surgical approaches for patients with high-grade brain tumors (glioma): standard maximal resection (removing as much tumor as safely possible) versus supramaximal resection (going beyond the visible tumor boundary using special techniques). The goal is to see if removing more tissue improves survival. **You may be eligible if:** - You are between 18 and 90 years old - Your MRI shows a high-grade glioma (WHO grade III or IV brain tumor) - You are able to give written informed consent **You may NOT be eligible if:** - Your tumor is in the cerebellum, brainstem, or midline - You have multiple separate contrast-enhancing tumor spots on MRI - You have a medical condition preventing MRI (such as a pacemaker) - Your high-grade glioma developed from a previous low-grade glioma - You have had another cancer in the last 5 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESupramaximal 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.

PROCEDUREMaximal safe resection

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


Locations(8)

University of California, San Francisco (UCSF)

San Francisco, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University Hospitals Leuven

Leuven, Belgium

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Technical University Munich

Munich, Bavaria, Germany

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Haaglanden Medical Centre

The Hague, South Holland, Netherlands

Inselspital Universitätsspital Bern

Bern, Switzerland

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NCT06118723


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