Comparing tumor resection and biopsy for high-grade glioma patients
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
This study is testing whether removing a brain tumor or just taking a small sample helps older patients with high-grade gliomas live longer and feel better afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 564 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT06146725 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival and quality of life outcomes in high-grade glioma patients aged 70 and older or with limited performance status. It is an international, multicenter, prospective study where patients will be treated with either resection or biopsy in a 3:1 ratio. The primary endpoints include overall survival and the proportion of patients receiving adjuvant treatment, while secondary endpoints focus on neurological morbidity and quality of life assessments post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 years diagnosed with high-grade glioma who can provide informed consent.
Not a fit: Patients with tumors located in the cerebellum, brainstem, or midline, or those with medical conditions preventing MRI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the optimal surgical approach for high-grade glioma patients, potentially improving survival and quality of life.
How similar studies have performed: While there is limited guidance on this specific comparison, similar studies have explored surgical approaches in glioma treatment, indicating a need for 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. Medical reasons precluding MRI (e.g. pacemaker) 3. Inability to give written informed consent 4. Secondary high-grade glioma due to malignant transformation from low-grade glioma 5. 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 — San Francisco, California, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University Hospital Leuven — Leuven, Belgium (Recruiting)
- Technical University Munich — Munich, Bavaria, Germany (Not_yet_recruiting)
- University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
- Haaglanden Medical Center — The Hague, 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.