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NCT06283927 · ClinicalTrials.gov registry record
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
A clinical trial of Glioblastoma and Glioblastoma Multiforme, sponsored by Jasper Gerritsen.
- Recruiting
- Registry status
- 464
- Enrollment target
- 8
- Study locations
NCT06283927 is a study of Glioblastoma and Glioblastoma Multiforme that is actively recruiting participants, run by Jasper Gerritsen. The registered enrollment target is 464 participants, above the 107-participant average among 199 other Glioblastoma trials with a reported enrollment target (334% higher). The trial reports 8 study locations across 4 states.
The verdict
NCT06283927, a study of Glioblastoma and Glioblastoma Multiforme, is actively recruiting participants, sponsored by Jasper Gerritsen.
- RECRUITING
- Registry status
- 464 participants
- Enrollment target
- 8
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Lomustine
- RADIATION Re-irradiation
- PROCEDURE Re-resection
- PROCEDURE Experimental therapy
Study Locations (8)
Other
- University Hospital Leuven - Leuven
- University Hospital Heidelberg - Heidelberg
- Technical University Munich - Munich
- Inselspital Universitätsspital Bern - Bern
South Holland
- Erasmus MC - Rotterdam
- Medical Center Haaglanden - The Hague
California
- University of California, San Francisco - San Francisco
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2028-01-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06283927
The ClinicalTrials.gov registry entry for NCT06283927 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 464 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 107-participant average among 199 other Glioblastoma trials with a reported enrollment target (334% higher). The listed sponsor is Jasper Gerritsen, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Temozolomide is the first listed.
NCT06283927 reports 8 study locations spanning 4 distinct geographic areas - top geographies include Other, South Holland, California.
Frequently Asked Questions
What is clinical trial NCT06283927 about?
NCT06283927 is a clinical study titled "The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)". 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 molecu...
What is the current status of trial NCT06283927?
This trial is currently recruiting. The enrollment target is 464 participants. The study started on 2023-01-01. Estimated completion is 2028-01-01.
What conditions does trial NCT06283927 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, Recurrent Glioblastoma, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme of Brain.
What interventions are being tested in trial NCT06283927?
The interventions under investigation include: Temozolomide (DRUG), Lomustine (DRUG), Re-irradiation (RADIATION), Re-resection (PROCEDURE), Experimental therapy (PROCEDURE).
Who is sponsoring clinical trial NCT06283927?
This trial is sponsored by Jasper Gerritsen, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06283927 being conducted?
This trial has 8 study locations across California, Massachusetts, South Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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