The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
NCT ID: NCT06146725
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
564 participants
OBSERVATIONAL
2023-01-01
2029-01-01
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tumor resection
Tumor resection
Tumor resection
Maximal safe resection of the tumor
Tumor biopsy
Tumor biopsy
Tumor biopsy
Biopsy of the tumor
Interventions
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Tumor resection
Maximal safe resection of the tumor
Tumor biopsy
Biopsy of the tumor
Eligibility Criteria
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Inclusion Criteria
2. Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
3. Written informed consent
Exclusion Criteria
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
18 Years
90 Years
ALL
No
Sponsors
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Haaglanden Medical Centre
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
University Hospital Heidelberg
OTHER
Technical University of Munich
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Massachusetts General Hospital
OTHER
University of California, San Francisco
OTHER
Jasper Gerritsen
OTHER
Responsible Party
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Jasper Gerritsen
Jasper K.W. Gerritsen MD PhD
Principal Investigators
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Jasper Gerritsen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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University of California, San Francisco
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University Hospital Leuven
Leuven, , Belgium
Technical University Munich
Munich, Bavaria, Germany
University Hospital Heidelberg
Heidelberg, , Germany
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Haaglanden Medical Center
The Hague, , Netherlands
Inselspital Universitätsspital Bern
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Mitchel Berger, MD PhD
Role: primary
Brian Nahed, MD
Role: primary
Steven De Vleeschouwer, MD PhD
Role: primary
Arthur Wagner, MD PhD
Role: primary
Christine Jungk, Dr. med.
Role: primary
Jasper Gerritsen, MD PhD
Role: primary
Marike Broekman, MD PhD
Role: primary
Philippe Schucht, MD PhD
Role: primary
References
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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.
Other Identifiers
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MEC-2020-0812-3
Identifier Type: -
Identifier Source: org_study_id