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

Recruitingn/aAges 18 Years - 90 YearsAllJasper Gerritsen
NCT06146725 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ha

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥18 years and ≤90 years 2. Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon 3. Written informed consent Exclusion Criteria: 1. Tumors of the cerebellum, brainstem or midline 2. Medical reasons precluding MRI (e.g. pacemaker) 3. Inability to give written informed consent 4. Secondary high-grade glioma due to malignant transformation from low-grade glioma 5. 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
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What it tests

  • Tumor resection
  • Tumor biopsy
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Where

8 sites
University of California, San Francisco
San Francisco, United States
Massachusetts General Hospital
Boston, United States
University Hospital Leuven
Leuven, Belgium
Technical University Munich
Munich, Germany
University Hospital Heidelberg
Heidelberg, Germany
Erasmus Medical Center
Rotterdam, Netherlands
Haaglanden Medical Center
The Hague, Netherlands
Inselspital Universitätsspital Bern
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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