564 Participants Needed

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

(RESBIOP Trial)

Recruiting at 7 trial locations
JG
AV
Overseen ByArnaud Vincent, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jasper Gerritsen
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JG

Jasper Gerritsen, MD PhD

Principal Investigator

Erasmus Medical Center

Eligibility Criteria

Inclusion Criteria

You have signed a form saying you agree to be in the study.
Your tumor is classified as high-grade (grade III/IV) based on MRI scans reviewed by a neurosurgeon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either tumor resection or biopsy

1 day
1 visit (in-person)

Adjuvant Treatment

Participants receive adjuvant treatment with chemotherapy and radiotherapy

6 months

Follow-up

Participants are monitored for safety, neurological morbidity, and quality of life

12 months
4 visits (in-person) at 6 weeks, 3 months, 6 months, and 12 months

Treatment Details

Participant Groups
2Treatment groups
Experimental Treatment
Group I: Tumor resectionExperimental Treatment1 Intervention
Tumor resection
Group II: Tumor biopsyExperimental Treatment1 Intervention
Tumor biopsy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jasper Gerritsen

Lead Sponsor

Trials
5
Recruited
3,100+

Universitaire Ziekenhuizen KU Leuven

Collaborator

Trials
1,048
Recruited
1,658,000+

Haaglanden Medical Centre

Collaborator

Trials
18
Recruited
11,200+

Insel Gruppe AG, University Hospital Bern

Collaborator

Trials
831
Recruited
2,353,000+

University Hospital Heidelberg

Collaborator

Trials
258
Recruited
278,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Technical University of Munich

Collaborator

Trials
395
Recruited
813,000+
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