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

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

• Glioblastoma
• Glioblastoma Multiforme
• Glioblastoma, IDH-wildtype
• Glioblastoma Multiforme of Brain
• Glioblastoma Multiforme, Adult
• Recurrent Glioblastoma
• Astrocytoma, Malignant
• Astrocytoma of Brain

Interventions

PROCEDURE

Re-resection

Resection of the recurrent tumor

DRUG

Temozolomide

Re-challenge Temozolomide chemotherapy

DRUG

Lomustine

Second line chemotherapy with Lomustine

RADIATION

Re-irradiation

Re-irradiation with single dose, fractionated, or hypofractionated radiation of the recurrent tumor

PROCEDURE

Experimental therapy

Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive)

OTHER

Best supportive care

Best supportive care, focused on alleviating symptoms

Sponsors & Collaborators

• Haaglanden Medical Centre

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• University Hospital Heidelberg

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Jasper Gerritsen

  lead OTHER

Principal Investigators

• Jasper Gerritsen, MD PhD · Erasmus Medical Center

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2027-01-01

Completion

2028-01-01

Countries

• United States
• Belgium
• Germany
• Netherlands
• Switzerland

Study Locations