The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tumor resection, Tumor biopsy.
- Who it may be relevant to
- Registry conditions: Glioblastoma, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Glioblastoma Multiforme, Adult. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Germany, Netherlands, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Trial design This is an international, multicenter, prospective, observational, 2-arm cohort study (registration: clinicaltrials.gov ID number TBA). Eligible patients are treated with either resection or biopsy with a 3:1 ratio with a sequential computer-generated random number as subject ID.
Study objectives The primary study objective is to evaluate safety and efficacy of resection versus biopsy in HGG patients as measured by overall survival (OS) and receipt of adjuvant treatment with chemotherapy and radiotherapy. Secondary study objectives are to evaluate postoperative neurological morbidity, progression-free survival (PFS), postoperative quality of life and SAEs after resection or biopsy as measured by NIHSS deteriration, tumor progression on MRI scans, quality of life questionnaires (QLQ C30, EORTC QLQ BN20, EQ 5D), and recording SAEs respectively.
Study setting and participants Patients will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals, located in Europe and the United States. The study is carried out by centers from the ENCRAM Consortium.
Study patients are allocated to either the supramaximal or maximum safe resection group and will undergo evaluation at presentation (baseline) and during the follow-up period at 6 weeks, 3 months, 6 months and 12 months postoperatively. Motor function will be evaluated using the NIHSS (National Institute of Health Stroke Scale) scale. Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). Patient functioning with be assessed with the Karnofsky Performance Scale (KPS) and the ASA (American Society of Anesthesiologists) physical status classification system. Health-related quality of life (HRQoL) will be assessed with the EORTC QLQ C30, EORTC QLQ BN20 and EQ 5D questionnaires. Overall survival and progression-free survival will be assessed at 12 months postoperatively. We expect to complete patient inclusion in 4 years. The estimated duration of the study (including follow-up) will be 5 years.
Interventions
- Procedure Tumor resection
Maximal safe resection of the tumor - Procedure Tumor biopsy
Biopsy of the tumor
Primary outcome measures
- Overall survival [Time frame: Up to 5 years postoperatively]
- Adjuvant treatment with chemotherapy and radiotherapy [Time frame: 6 months postoperatively]
Secondary outcome measures (12)
- Progression-free survival [Time frame: Up to 5 years postoperatively]
- Neurological morbidity at 6 weeks [Time frame: 6 weeks postoperatively]
- Neurological morbidity at 3 months [Time frame: 3 months postoperatively]
- Neurological morbidity at 6 months [Time frame: 6 months postoperatively]
- Quality of life at 6 weeks (EORTC QLQ C30) [Time frame: 6 weeks postoperatively]
- Quality of life at 3 months (EORTC QLQ C30) [Time frame: 3 months postoperatively]
- Quality of life at 6 months (EORTC QLQ C30) [Time frame: 6 months postoperatively]
- Quality of life at 6 weeks (EORTC QLQ BN20) [Time frame: 6 weeks postoperatively]
- Quality of life at 3 months (EORTC QLQ BN20) [Time frame: 3 months postoperatively]
- Quality of life at 6 months (EORTC QLQ BN20) [Time frame: 6 months postoperatively]
- Quality of life at 6 weeks (EQ-5D) [Time frame: 6 weeks postoperatively]
- Quality of life at 3 months (EQ-5D) [Time frame: 3 months postoperatively]
Eligibility criteria
Inclusion criteria
- Age ≥18 years and ≤90 years
- Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
- Written informed consent
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- University of California, San Francisco — San Francisco
- Massachusetts General Hospital — Boston
Germany · 2 centers
- Technical University Munich — Munich
- University Hospital Heidelberg — Heidelberg
Netherlands · 2 centers
- Erasmus Medical Center — Rotterdam
- Haaglanden Medical Center — The Hague
Belgium · 1 center
- University Hospital Leuven — Leuven
Switzerland · 1 center
- Inselspital Universitätsspital Bern — Bern
Publications
- Gerritsen JKW, Young JS, Krieg SM, Jungk C, Ille S, Schucht P, Nahed BV, Broekman MLD, Berger M, De Vleeschouwer S, Vincent AJPE. Resection versus biopsy in patients with glioblastoma (RESBIOP study): study protocol for an international multicentre prospective cohort study (ENCRAM 2202). BMJ Open. 2024 Sep 10;14(9):e081689. doi: 10.1136/bmjopen-2023-081689. PMID 39260848
Identifiers
NCT: NCT06146725 · MEC-2020-0812-3