NCT06283927 The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
| NCT ID | NCT06283927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jasper Gerritsen |
| Condition | Glioblastoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 464 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 464 participants in total. It began in 2023-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups. This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.
Eligibility 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
Contact & Investigator
Jasper Gerritsen, MD PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06283927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06283927 currently recruiting?
Yes, NCT06283927 is actively recruiting participants. Contact the research team at j.gerritsen@erasmusmc.nl for enrollment information.
Where is the NCT06283927 trial being conducted?
This trial is being conducted at San Francisco, United States, Boston, United States, Leuven, Belgium, Heidelberg, Germany and 4 additional locations.
Who is sponsoring the NCT06283927 clinical trial?
NCT06283927 is sponsored by Jasper Gerritsen. The principal investigator is Jasper Gerritsen, MD PhD at Erasmus Medical Center. The trial plans to enroll 464 participants.
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