The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
(RESBIOP Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Jasper Gerritsen, MD PhD
Principal Investigator
Erasmus Medical Center
Eligibility Criteria
Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo either tumor resection or biopsy
Adjuvant Treatment
Participants receive adjuvant treatment with chemotherapy and radiotherapy
Follow-up
Participants are monitored for safety, neurological morbidity, and quality of life
Treatment Details
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jasper Gerritsen
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
Haaglanden Medical Centre
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
University Hospital Heidelberg
Collaborator
University of California, San Francisco
Collaborator
Massachusetts General Hospital
Collaborator
Technical University of Munich
Collaborator