GlioblastomaRECSURNCT06283927
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
An observational study of Glioblastoma and Glioblastoma Multiforme, run by Jasper Gerritsen at 8 sites in 5 countries.
Trial summary
Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype
- What is being tested?
- Re-resection, Temozolomide and Lomustine
- Type of treatment
- Surgery or procedure
- How many people
- 464 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 1 Jan 2023to 1 Jan 2028
- 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 recurrent glioblastoma 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 recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma
- The tumor is suitable for resection (according to 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
- Clinical data unavailable for the newly diagnosed setting
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 PhD
- 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
Arthur Wagner, MD
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015 CE
Arnaud Vincent, MD PhD, +31639428949, a.vincent@erasmusmc.nl
Jasper Gerritsen, MD, +31629119553, j.gerritsen@erasmusmc.nl
- Recruiting
Medical Center Haaglanden
The Hague, South Holland, 2261 CP
Marike Broekman, MD PhD, +31639758253, m.broekman@haaglandenmc.nl
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
Philippe Schucht, MD PhD
About this study
Official title: The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2302)
Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.
This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.
The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.
Read the detailed description
This is an international, multicenter, prospective, cohort study. Eligible patients are operated or receive best oncological treatment with a 1:1 ratio with a sequential computer-generated random number as subject ID. Intraoperative mapping techniques and/or surgical adjuncts can be used in both treatment arms to ensure the safety of the resection (to minimize the risk of postoperative deficits).
Study patients undergo tumor re-resection or receive best oncological treatment and will undergo evaluation at presentation (baseline) and during the follow-up period at 6 weeks, 3 months, and 6 months postoperatively. Motor function will be evaluated using the NIHSS (National Institute of Health Stroke Scale) and MRC (Medical Research Council) scale. Language function will be evaluated using a standard neurolinguistic test-battery consisting of the Aphasia Bedside Check (ABC), Shortened Token test, Verbal fluency, Picture description and Object naming. This neurolinguistic test-battery is the result of a consensus between the participating centers. Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). Overall patient functioning with be assessed with the Karnofsky Performance Scale (KPS) and the ASA (American Society of Anesthesiologists) physical status classification system for comorbidities. Health-related quality of life (HRQoL) will be assessed with the EQ-5D questionnaire and the EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Overall survival and progression-free survival will be assessed. We expect to complete patient inclusion in 4 years. The estimated duration of the study, including follow-up, will be 5 years.
The primary study objective is to evaluate the safety and efficacy of re-resection versus best oncological treatment (neurological morbidity and overall survival) in recurrent glioblastoma patients as expressed by NIHSS scores and survival data. Secondary study objectives are to study the overall progressive-free survival (PFS), long-term neurological morbidity (3 months and 6 months postoperatively), health-related quality of life (HRQoL), and Serious Adverse Events (SAEs) after resection versus best oncological treatment as expressed by progression on follow up MRI scans based on the RANO criteria24 for tumor progression; NIHSS scores, quality of life questionnaires (EORTC QLQ C30, EORTC QLQ BN20, EQ-5D), and registration of SAEs.
Patients will be recruited for the study from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals of the ENCRAM Research Consortium, located in Europe and the United States.
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme of Brain, Glioblastoma Multiforme, Adult, Recurrent Glioblastoma
- Being tested
- Re-resection, Temozolomide, Lomustine, Re-irradiation, Experimental therapy
- Keywords
- Glioblastoma, Radiotherapy, Chemotherapy, Re-resection, Resection, Overall survival, Progression-free survival, Neurological morbidity, Safety, Serious Adverse Events, Quality of life
- Medical subject headings
- Glioblastoma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-resectionProcedure or surgery
Resection of the recurrent tumor
TemozolomideDrug
Re-challenge Temozolomide chemotherapy
LomustineDrug
Second line chemotherapy with Lomustine
Re-irradiationRadiation
Re-irradiation with single dose, fractionated, or hypofractionated radiation of the recurrent tumor
Experimental therapyProcedure or surgery
Also called Immunotherapy, Oncolytic virotherapy
Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive)
Best supportive careOther
Best supportive care, focused on alleviating symptoms
| Study group | Role | What they receive |
|---|---|---|
| Re-resection | Resection of the recurrent tumor Receives: Procedure: Re-resection | |
| Best oncological treatment | Best oncological treatment consisting of re-challenge temozolomide, re-irradiation, experimental therapy, or best supportive care Receives: Drug: Temozolomide; Drug: Lomustine; Radiation: Re-irradiation; Procedure: Experimental therapy; Other: Best supportive care |
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
Neurological morbidity at 6 weeks
NIHSS deterioration of 1 point or more at 6 weeks after surgery
Measured: 6 weeks postoperatively
Secondary outcomes (14)
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
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
Residual tumor volume
Residual tumor volume of the contrast-enhancing and non-contrast enhancing part, as assessed by a neuroradiologist on postoperative MRI scan (T1 with contrast and FLAIR sequences) using manual or semi-automatic volumetric analyses (Brainlab Elements iPlan CMF Segmentation, Brainlab AG, Munich, Germany; or similar software)
Measured: Within 72 hours 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 posted28 Feb 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 464 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
- NCT06283927
- Sponsor's protocol ID
- MEC-2020-0812-5
- Acronym
- RECSUR
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2302)
- ClinicalTrials.gov ID
- NCT06283927
- Acronym / sponsor ID
- RECSUR / MEC-2020-0812-5
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme of Brain, Glioblastoma Multiforme, Adult, Recurrent Glioblastoma
- Keywords
- Glioblastoma, Radiotherapy, Chemotherapy, Re-resection, Resection, Overall survival, Progression-free survival, Neurological morbidity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 464 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 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 28 Feb 2024 (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.
Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.
This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.
The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.
Detailed description
This is an international, multicenter, prospective, cohort study. Eligible patients are operated or receive best oncological treatment with a 1:1 ratio with a sequential computer-generated random number as subject ID. Intraoperative mapping techniques and/or surgical adjuncts can be used in both treatment arms to ensure the safety of the resection (to minimize the risk of postoperative deficits).
Study patients undergo tumor re-resection or receive best oncological treatment and will undergo evaluation at presentation (baseline) and during the follow-up period at 6 weeks, 3 months, and 6 months postoperatively. Motor function will be evaluated using the NIHSS (National Institute of Health Stroke Scale) and MRC (Medical Research Council) scale. Language function will be evaluated using a standard neurolinguistic test-battery consisting of the Aphasia Bedside Check (ABC), Shortened Token test, Verbal fluency, Picture description and Object naming. This neurolinguistic test-battery is the result of a consensus between the participating centers. Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). Overall patient functioning with be assessed with the Karnofsky Performance Scale (KPS) and the ASA (American Society of Anesthesiologists) physical status classification system for comorbidities. Health-related quality of life (HRQoL) will be assessed with the EQ-5D questionnaire and the EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Overall survival and progression-free survival will be assessed. We expect to complete patient inclusion in 4 years. The estimated duration of the study, including follow-up, will be 5 years.
The primary study objective is to evaluate the safety and efficacy of re-resection versus best oncological treatment (neurological morbidity and overall survival) in recurrent glioblastoma patients as expressed by NIHSS scores and survival data. Secondary study objectives are to study the overall progressive-free survival (PFS), long-term neurological morbidity (3 months and 6 months postoperatively), health-related quality of life (HRQoL), and Serious Adverse Events (SAEs) after resection versus best oncological treatment as expressed by progression on follow up MRI scans based on the RANO criteria24 for tumor progression; NIHSS scores, quality of life questionnaires (EORTC QLQ C30, EORTC QLQ BN20, EQ-5D), and registration of SAEs.
Patients will be recruited for the study from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals of the ENCRAM Research Consortium, located in Europe and the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Re-resection | – | Procedure: Re-resectionResection of the recurrent tumor |
| Best oncological treatment | – | Drug: Temozolomide, Drug: Lomustine, Radiation: Re-irradiation, Procedure: Experimental therapy, Other: Best supportive careBest oncological treatment consisting of re-challenge temozolomide, re-irradiation, experimental therapy, or best supportive care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent glioblastoma 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 (4 listed)
- Age ≥18 years and ≤90 years
- Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma
- The tumor is suitable for resection (according to 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
- Clinical data unavailable for the newly diagnosed setting
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 |
|---|---|---|
| Re-resectionResection of the recurrent tumor | Procedure or surgery | Re-resection |
| TemozolomideRe-challenge Temozolomide chemotherapy | Drug | Best oncological treatment |
| LomustineSecond line chemotherapy with Lomustine | Drug | Best oncological treatment |
| Re-irradiationRe-irradiation with single dose, fractionated, or hypofractionated radiation of the recurrent tumor | Radiation | Best oncological treatment |
| Experimental therapyAlso: Immunotherapy, Oncolytic virotherapyExperimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive) | Procedure or surgery | Best oncological treatment |
| Best supportive careBest supportive care, focused on alleviating symptoms | Other | Best oncological treatment |
Primary outcome
Overall survival
Time frame: Up to 5 years postoperatively
Time from diagnosis to death from any cause
Neurological morbidity at 6 weeks
Time frame: 6 weeks postoperatively
NIHSS deterioration of 1 point or more at 6 weeks after surgery
14 secondary outcomes
Neurological morbidity at 3 months
Time frame: 3 months postoperatively
Neurological morbidity at 6 months
Time frame: 6 months postoperatively
Progression-free survival
Time frame: Up to 5 years postoperatively
Residual tumor volume
Time frame: Within 72 hours 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 28 Feb 2024.
- 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 Multiforme, 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 4 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 28 Feb 2024. 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?
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 28 Feb 2024.