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NCT06118723 · ClinicalTrials.gov registry record
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
A clinical trial of Glioblastoma and High Grade Glioma, sponsored by Jasper Gerritsen.
- Recruiting
- Registry status
- 784
- Enrollment target
- 8
- Study locations
NCT06118723: Recruiting study of Glioblastoma and High Grade Glioma, sponsored by Jasper Gerritsen.
NCT06118723 is a study of Glioblastoma and High Grade Glioma that is actively recruiting participants, run by Jasper Gerritsen. The registered enrollment target is 784 participants, above the 105-participant average among 199 other Glioblastoma trials with a reported enrollment target (647% higher). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06118723, a study of Glioblastoma and High Grade Glioma, is actively recruiting participants, sponsored by Jasper Gerritsen.
- RECRUITING
- Registry status
- 784 participants
- Enrollment target
- 8
- Study locations
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).
Primary Outcome
Time from diagnosis to death from any cause
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 784 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2028-01-01 |
What NCT06118723 shows while recruiting
NCT06118723 is an observational study that tracks outcomes without assigning an intervention. The registered 784 participants enrollment target is mid-sized for trials with a published cap, above the 105-participant average among 199 other Glioblastoma trials with a reported enrollment target (647% higher).
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.
NCT06118723 lists 8 locations in 6 states (Other, South Holland, California).
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, High Grade Glioma, Glioblastoma, IDH-wildtype, Brain Neoplasms, Glioblastoma Multiforme, Adult.
What interventions are being tested in trial NCT06118723?
The interventions under investigation include: Supramaximal resection (PROCEDURE), Maximal safe resection (PROCEDURE).
Who is sponsoring clinical trial NCT06118723?
This trial is sponsored by Jasper Gerritsen, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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Where NCT06118723's enrollment target sits among peer trials
784 4th of 199 higher than 196 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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