GlioblastomaRESBIOPNCT06146725
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
An observational study of Glioblastoma and Glioblastoma, IDH-wildtype, run by Jasper Gerritsen at 8 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glioblastoma, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme
- What is being tested?
- Tumor resection and Tumor biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 564 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 1 Jan 2023to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients with primary high-grade glioma 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.
Who may be able to join
- Age ≥18 years and ≤90 years
- Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 5 countries
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brian Nahed, MD
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Mitchel Berger, MD PhD
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Heidelberg
Heidelberg
Christine Jungk, Dr. med.
- Not yet recruiting
Technical University Munich
Munich, Bavaria, 74076
Arthur Wagner, MD PhD
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
Jasper Gerritsen, MD PhD
- Recruiting
Haaglanden Medical Center
The Hague
Marike Broekman, MD PhD
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Leuven
Leuven
Steven De Vleeschouwer, MD PhD
Switzerland1 site, 1 recruiting
- Not yet recruiting
Inselspital Universitätsspital Bern
Bern, 3010
Philippe Schucht, MD PhD
About this study
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.
Read the 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.
- Conditions
- Glioblastoma, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Glioblastoma Multiforme, Adult, Glioblastoma Multiforme of Brain
- Being tested
- Tumor resection, Tumor biopsy
- Keywords
- Resection, Biopsy, Survival, Quality of life
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor resectionProcedure or surgery
Maximal safe resection of the tumor
Tumor biopsyProcedure or surgery
Biopsy of the tumor
| Study group | Role | What they receive |
|---|---|---|
| Tumor resection | Tumor resection Receives: Procedure: Tumor resection | |
| Tumor biopsy | Tumor biopsy Receives: Procedure: Tumor biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from diagnosis to death from any cause
Measured: Up to 5 years postoperatively
Adjuvant treatment with chemotherapy and radiotherapy
Proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy after surgery
Measured: 6 months postoperatively
Secondary outcomes (14)
Progression-free survival
Time from diagnosis to disease progression (occurrence of a new tumor lesions with a volume greater than 0.175 cm3, or an increase in residual tumor volume of more than 25%) or death, whichever comes first
Measured: Up to 5 years postoperatively
Neurological morbidity at 6 weeks
NIHSS deterioration of 1 point or more at 6 weeks after surgery
Measured: 6 weeks postoperatively
Neurological morbidity at 3 months
NIHSS deterioration of 1 point or more at 3 months after surgery
Measured: 3 months postoperatively
Neurological morbidity at 6 months
NIHSS deterioration of 1 point or more at 6 months after surgery
Measured: 6 months postoperatively
Quality of life at 6 weeks (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Measured: 6 weeks postoperatively
Quality of life at 3 months (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Measured: 3 months postoperatively
Quality of life at 6 months (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Measured: 6 months postoperatively
Quality of life at 6 weeks (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Measured: 6 weeks postoperatively
Quality of life at 3 months (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Measured: 3 months postoperatively
Quality of life at 6 months (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Measured: 6 months postoperatively
Quality of life at 6 weeks (EQ-5D)
Quality of life as assessed by the EQ-5D questionnaire
Measured: 6 weeks postoperatively
Quality of life at 3 months (EQ-5D)
Quality of life as assessed by the EQ-5D questionnaire
Measured: 3 months postoperatively
Quality of life at 6 months (EQ-5D)
Quality of life as assessed by the EQ-5D questionnaire
Measured: 6 months postoperatively
Serious Adverse Events
Serious Adverse Events within 6 weeks postoperatively
Measured: 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jasper Gerritsen
- Sponsor type
- University, hospital or other
- Collaborators
- Haaglanden Medical Centre, Universitaire Ziekenhuizen KU Leuven, University Hospital Heidelberg, Technical University of Munich, Insel Gruppe AG, University Hospital Bern, Massachusetts General Hospital, University of California, San Francisco
- Responsible party
- Sponsor-investigator, Jasper Gerritsen, Erasmus Medical Center
- Investigators
- Jasper Gerritsen, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146725
- Sponsor's protocol ID
- MEC-2020-0812-3
- Acronym
- RESBIOP
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 39260848
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
- ClinicalTrials.gov ID
- NCT06146725
- Acronym / sponsor ID
- RESBIOP / MEC-2020-0812-3
- Conditions
- Glioblastoma, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Glioblastoma Multiforme, Adult, Glioblastoma Multiforme of Brain
- Keywords
- Resection, Biopsy, Survival, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Jasper GerritsenUniversity, hospital or other
- Collaborators
- Haaglanden Medical Centre, Universitaire Ziekenhuizen KU Leuven, University Hospital Heidelberg, Technical University of Munich, Insel Gruppe AG, University Hospital Bern, Massachusetts General Hospital, University of California, San Francisco
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor resection | – | Procedure: Tumor resectionTumor resection |
| Tumor biopsy | – | Procedure: Tumor biopsyTumor biopsy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with primary high-grade glioma 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.
Key inclusion criteria (3 listed)
- Age ≥18 years and ≤90 years
- Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor resectionMaximal safe resection of the tumor | Procedure or surgery | Tumor resection |
| Tumor biopsyBiopsy of the tumor | Procedure or surgery | Tumor biopsy |
Primary outcome
Overall survival
Time frame: Up to 5 years postoperatively
Time from diagnosis to death from any cause
Adjuvant treatment with chemotherapy and radiotherapy
Time frame: 6 months postoperatively
Proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy after surgery
14 secondary outcomes
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
Quality of life at 6 months (EQ-5D)
Time frame: 6 months postoperatively
Serious Adverse Events
Time frame: 6 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Derived from this study: PubMed 39260848Gerritsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jasper Gerritsen, MD PhD principal investigator
Erasmus Medical Center
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma and Glioblastoma, IDH-wildtype, run by Jasper Gerritsen at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany, Netherlands, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasper Gerritsen, MD PhD (+31107036130, j.gerritsen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 5 years postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06146725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.