The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
Recruiting now
Conditions studied: Glioblastoma, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Glioblastoma Multiforme, Adult, Glioblastoma Multiforme of Brain
In brief
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.
Key facts
- Study ID
- NCT06146725
- Run by
- Jasper Gerritsen
- People needed
- 564
- Starts
- 2023-01-01
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2023-11-27
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years and ≤90 years
- Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
- Written informed consent
You may not qualify if…
- Tumors of the cerebellum, brainstem or midline
- Medical reasons precluding MRI (e.g. pacemaker)
- Inability to give written informed consent
- Secondary high-grade glioma due to malignant transformation from low-grade glioma
- Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin
Where it is running
- University of California, San Francisco — San Francisco, California, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- University Hospital Leuven — Leuven, Belgium (enrolling)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (enrolling)
- Haaglanden Medical Center — The Hague, Netherlands (enrolling)
- University Hospital Heidelberg — Heidelberg, Germany (enrolling)
- Technical University Munich — Munich, Bavaria, Germany
- Inselspital Universitätsspital Bern — Bern, Switzerland
Full record on ClinicalTrials.gov
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