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RECRUITING

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

NCT06118723 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • PROCEDURE Supramaximal resection
  • PROCEDURE Maximal safe resection

Study Locations (8)

Other

  • University Hospitals Leuven — Leuven
  • Inselspital Universitätsspital Bern — Bern

South Holland

  • Erasmus Medical Center — Rotterdam
  • Haaglanden Medical Centre — The Hague

California

  • University of California, San Francisco (UCSF) — San Francisco

Massachusetts

  • Massachusetts General Hospital — Boston

Baden-Wurttemberg

  • Universitätsklinikum Heidelberg — Heidelberg

Bavaria

  • Technical University Munich — Munich

Trial Details

FieldValue
Enrollment Target 784 participants
Start Date 2022-01-01
Est. Completion 2028-01-01

Sponsor

Jasper Gerritsen

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06118723

The ClinicalTrials.gov registry entry for NCT06118723 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 784 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jasper Gerritsen, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions — of which Supramaximal resection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06118723 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Other, South Holland, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06118723 about?

NCT06118723 is a clinical study titled "The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)". 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). Th...

What is the current status of trial NCT06118723?

This trial is currently recruiting. The enrollment target is 784 participants. The study started on 2022-01-01. Estimated completion is 2028-01-01.

What conditions does trial NCT06118723 study?

This clinical trial studies the following conditions: Glioblastoma, Brain Neoplasms, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Adult, High-grade Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06118723?

The interventions under investigation include: Supramaximal resection (PROCEDURE), Maximal safe resection (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06118723?

This trial is sponsored by Jasper Gerritsen, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06118723 being conducted?

This trial has 8 study locations across California, Massachusetts, Baden-Wurttemberg, Bavaria, South Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial