Actively Recruiting
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
Led by Jasper Gerritsen · Updated on 2024-02-22
784
Participants Needed
8
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Jasper Gerritsen
Lead Sponsor
H
Haaglanden Medical Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two surgical approaches—supramaximal resection and maximal safe resection—in 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 1:3 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older, up to 90 years
- Diagnosis of high-grade glioma (WHO grade III or IV) confirmed by MRI
- Able to provide written informed consent
You will not qualify if you...
- Tumors located in the cerebellum, brainstem, or midline
- Multiple contrast-enhancing tumor lesions
- Medical conditions preventing MRI (e.g., pacemaker)
- Unable to provide written informed consent
- High-grade glioma due to transformation from low-grade glioma
- Diagnosis of a second primary cancer within 5 years, except certain treated skin or in situ carcinomas
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo either supramaximal resection or maximal safe resection surgery for high-grade glioma.
1 visit (in-person)
Duration - 6 months
Participants are evaluated at 6 weeks, 3 months, and 6 months after surgery to assess neurological function, quality of life, and tumor progression.
3 visits (in-person) at 6 weeks, 3 months, and 6 months postoperatively
Duration - Up to 5 years
Participants are followed for up to 5 years postoperatively to monitor overall survival and progression-free survival.
Visits as scheduled for survival and progression assessments
Trial Site Locations
Total: 8 locations
1
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94143
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
University Hospitals Leuven
Leuven, Belgium, 3000
Actively Recruiting
4
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
5
Technical University Munich
Munich, Bavaria, Germany, 74076
Not Yet Recruiting
6
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
7
Haaglanden Medical Centre
The Hague, South Holland, Netherlands, 2512 VA
Actively Recruiting
8
Inselspital Universitätsspital Bern
Bern, Switzerland, 3010
Not Yet Recruiting
Research Team
J
Jasper Gerritsen, MD PhD
A
Arnaud Vincent, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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