πŸ›οΈ Verified NIH Record β€’ Updated 2024-02-21

The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) (NCT06283927)

🟒 Recruiting Interventional Protocol πŸ“Š Observational Clinical Research Sponsor: Jasper Gerritsen

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (6 items).

Location: University of California, San Francisco β€” San Francisco, California

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Tumors of the cerebellum, brainstem, or midline
  • Medical reasons precluding MRI (e.g., pacemaker)
  • Inability to give written informed consent
  • Secondary high-grade glioma due to malignant transformation from low-grade glioma
  • Clinical data unavailable for the newly diagnosed setting

πŸ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

πŸ“ All Participating Trial Locations (8 Sites)

  • University of California, San Francisco β€” San Francisco, California
  • Massachusetts General Hospital β€” Boston, Massachusetts
  • University Hospital Leuven β€” Leuven,
  • University Hospital Heidelberg β€” Heidelberg,
  • Technical University Munich β€” Munich,
  • Erasmus MC β€” Rotterdam, South Holland
  • Medical Center Haaglanden β€” The Hague, South Holland
  • Inselspital UniversitΓ€tsspital Bern β€” Bern,

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
πŸ›οΈ View Official NIH Record β†—