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ID06118723

Study Comparing Supramaximal and Maximal Tumor Removal in Adults with High-Grade Glioma

Led by Jasper Gerritsen · Updated on 2024-02-22

784

Participants Needed

8

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two surgical approachessupramaximal resection and maximal safe resectionin patients with high-grade glioma HGG, a type of aggressive brain tumor. This international, multicenter observational study aims to compare these methods in terms of overall survival, neurological function, cognitive ability, and quality of life. The study also seeks to identify which patients may benefit most from supramaximal resection and how to select them before surgery. Participants will undergo either supramaximal resection, where surgeons remove the contrast-enhancing tumor plus up to 5 cm3 of the non-contrast-enhancing tumor, or maximal safe resection, which targets only the contrast-enhancing tumor. Surgical adjuncts and mapping techniques may be used in both groups to reduce the risk of postoperative deficits. Patients are assigned to these groups at a 13 ratio, and both surgical approaches are carefully monitored with advanced imaging and neurological assessments. During the study, patients will be evaluated before surgery and followed up at 6 weeks, 3 months, and 6 months after surgery. Assessments include neurological exams using the NIH Stroke Scale, language and cognitive tests, performance status scales, and questionnaires on health-related quality of life. Imaging will measure residual tumor volumes and track disease progression. The main outcomes are overall survival and neurological changes after surgery, with additional monitoring of progression-free survival, functional outcomes, and adverse events over a total follow-up period expected to last up to five years.

CONDITIONS

Brief Title

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

Research Team

J

Jasper Gerritsen, MD PhD

A

Arnaud Vincent, MD PhD

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