Comparing two surgical approaches for high-grade glioma patients
The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
This study is testing whether a more extensive surgical method for removing high-grade brain tumors helps patients live longer and feel better compared to a standard approach.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 784 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT06118723 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and safety of supramaximal resection (SMR) versus maximal resection in patients with high-grade gliomas. It aims to determine which surgical approach leads to better survival outcomes and assesses the impact on neurological, cognitive, and quality of life measures. Patients will be allocated to either treatment group and monitored at baseline and during follow-up at 6 weeks, 3 months, and 6 months post-surgery. The study also seeks to identify preoperative factors that predict which patients will benefit most from SMR.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with a diagnosis of high-grade glioma who can provide informed consent.
Not a fit: Patients with tumors located in the cerebellum, brainstem, or midline, or those with multifocal lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with high-grade gliomas.
How similar studies have performed: Previous studies have suggested that greater tumor resection can improve outcomes, but this specific approach of supramaximal resection is novel and requires further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years and ≤90 years 2. Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon 3. Written informed consent Exclusion Criteria: 1. Tumors of the cerebellum, brainstem or midline 2. Multifocal contrast enhancing lesions 3. Medical reasons precluding MRI (e.g. pacemaker) 4. Inability to give written informed consent 5. Secondary high-grade glioma due to malignant transformation from low-grade glioma 6. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin
Where this trial is running
San Francisco, California and 7 other locations
- University of California, San Francisco (UCSF) — San Francisco, California, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University Hospitals Leuven — Leuven, Belgium (Recruiting)
- Universitätsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
- Technical University Munich — Munich, Bavaria, Germany (Not_yet_recruiting)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
- Haaglanden Medical Centre — The Hague, South Holland, Netherlands (Recruiting)
- Inselspital Universitätsspital Bern — Bern, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Jasper Gerritsen, MD PhD — Erasmus Medical Center
- Study coordinator: Jasper Gerritsen, MD PhD
- Email: j.gerritsen@erasmusmc.nl
- Phone: +31107036130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.