Comparing surgery and best treatment for recurrent glioblastoma
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2302)
This study is testing whether surgery or the best available treatment helps people with recurring glioblastoma feel better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 464 (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 | NCT06283927 on ClinicalTrials.gov |
What this trial studies
This international, multicenter, prospective observational cohort study aims to compare the effects of tumor resection versus best oncological treatment for patients with recurrent glioblastoma. Patients will be assigned to either treatment option at a 1:1 ratio based on a tumor board decision. The study will evaluate primary endpoints such as NIHSS deterioration at 6 weeks post-surgery and overall survival, along with secondary endpoints including progression-free survival and various functional assessments. The study will utilize intraoperative mapping techniques to enhance safety during resection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with recurrent glioblastoma suitable for resection.
Not a fit: Patients with tumors located in the cerebellum, brainstem, or midline, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the optimal treatment approach for recurrent glioblastoma, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown mixed results regarding the benefits of resection for recurrent glioblastoma, making this approach both relevant and necessary for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years and ≤90 years 2. Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma 3. The tumor is suitable for resection (according to neurosurgeon) 4. 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. Clinical data unavailable for the newly diagnosed setting
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)
- University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
- Technical University Munich — Munich, Germany (Not_yet_recruiting)
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
- Medical Center Haaglanden — 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.