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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
View:

• Age ≥18 years and ≤90 years

• Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon

• Written informed consent

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Other Locations
Belgium
University Hospital Leuven
RECRUITING
Leuven
Germany
University Hospital Heidelberg
RECRUITING
Heidelberg
Technical University Munich
NOT_YET_RECRUITING
Munich
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Haaglanden Medical Center
RECRUITING
The Hague
Switzerland
Inselspital Universitätsspital Bern
NOT_YET_RECRUITING
Bern
Contact Information
Primary
Jasper Gerritsen, MD PhD
j.gerritsen@erasmusmc.nl
+31107036130
Backup
Arnaud Vincent, MD PhD
a.vincent@erasmusmc.nl
+31107034211
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 564
Treatments
Tumor resection
Tumor resection
Tumor biopsy
Tumor biopsy
Sponsors
Leads: Jasper Gerritsen
Collaborators: Massachusetts General Hospital, Universitaire Ziekenhuizen KU Leuven, Insel Gruppe AG, University Hospital Bern, Technical University of Munich, University of California, San Francisco, Haaglanden Medical Centre, University Hospital Heidelberg

This content was sourced from clinicaltrials.gov

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