The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)

Summary

There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationally and at times even within an instiutition. This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival, functional, neurological, and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximize the potential to undergo adjuvant treatment.

This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be treated with resection or biopsy at a 3:1 ratio. Primary endpoints are: 1) overall survival (OS) and 2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months and 6 months after surgery 2) progression-free survival (PFS); 3) quality of life at 6 weeks, 3 months and 6 months after surgery and 4) frequency and severity of Serious Adverse Events (SAEs). Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

Conditions

• Glioblastoma
• Glioblastoma, IDH-wildtype
• Glioblastoma Multiforme
• Glioblastoma Multiforme, Adult
• Glioblastoma Multiforme of Brain

Interventions

PROCEDURE

Tumor resection

Maximal safe resection of the tumor

PROCEDURE

Tumor biopsy

Biopsy of the tumor

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

2028-01-01

Completion

2029-01-01

Countries

• United States
• Belgium
• Germany
• Netherlands
• Switzerland

Study Locations