GlioblastomaSUPRAMAXNCT06118723
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
An observational study of Glioblastoma and High-grade Glioma, run by Jasper Gerritsen at 8 sites in 5 countries.
Trial summary
A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glioblastoma, High-grade Glioma, Glioblastoma, IDH-wildtype
- What is being tested?
- Supramaximal resection and Maximal safe resection
- Type of treatment
- Surgery or procedure
- How many people
- 784 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 1 Jan 2022to 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 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
- Multifocal contrast enhancing lesions
- 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 (UCSF)
San Francisco, California, 94143
Mitchel Berger, MD
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Christine Jungk, MD PhD
Sandro Krieg, MD MBA
- 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 Centre
The Hague, South Holland, 2512 VA
Marike Broekman, MD PhD
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Steven De Vleeschouwer, MD PhD
Switzerland1 site, 1 recruiting
- Not yet recruiting
Inselspital Universitätsspital Bern
Bern, 3010
Philippe Schucht, MD PhD
About this study
Official title: The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively.
This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively.
The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).
Read the detailed description
This is an international, multicenter, prospective, observational, 2-arm cohort study (registration: clinicaltrials.gov ID number TBA). Eligible patients are operated with supramaximal resection versus maximal resection with a 1:3 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). Supramaximal resection is defined as 0 cm3 CE tumor and 5 cm3 or less NCE tumor, whereas maximal resection is defined as 0 cm3 CE tumor and >5 cm3 NCE tumor (in line with the updated RANO criteria).
Study patients are allocated to either the supramaximal or maximal safe resection group 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) 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. 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. 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 supramaximal resection versus safe maximal resection in HGG patients as measured by overall survival (OS) and postoperative NIHSS deterioration. Secondary study objectives are to evaluate extent of resection of CE and NCE tumor, quality of life, progression-free survival (PFS), onco-functional outcome (OFO), and SAEs after SMR or maximal safe resections as measured by volumetric analyses of contrast-enhanced MRI images with gadolinium combined with FLAIR images, tumor progression on MRI scans, quality of life questionnaires (EORTC QLQ C30, EORTC QLQ BN20, EQ 5D), combining postoperative residual volume with NIHSS outcomes, and recording SAEs respectively.
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.
- Conditions
- Glioblastoma, High-grade Glioma, Glioblastoma, IDH-wildtype, Glioblastoma, IDH-mutant, Glioblastoma Multiforme, Adult, Astrocytoma, Grade IV
- Being tested
- Supramaximal resection, Maximal safe resection
- Keywords
- Glioblastoma, Supramaximal resection, FLAIRectomy, Non-contrast enhancement, Neurological morbidity, Quality of life, Overall survival, Progression-free survival
- Medical subject headings
- Glioblastoma, Glioma, Astrocytoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supramaximal resectionProcedure or surgery
Also called Supramarginal resection, FLAIRectomy, Resection of the non-contrast-enhancing tumor
Supramaximal resection. Tumor resection continues until either the FLAIR abnormalities have been resected based on the neuronavigation (after updating the navigation intraoperatively), or when subcortical tracts are identified with intraoperative stimulation.
Maximal safe resectionProcedure or surgery
Maximal safe resection. Tumor resection continues until maximal safe resection has been achieved as by the neurosurgeon's opinion.
| Study group | Role | What they receive |
|---|---|---|
| Supramaximal resection | Supramaximal resection: maximal resection of the contrast-enhancing and non-contrast-enhancing part of the tumor (FLAIRectomy) Receives: Procedure: Supramaximal resection | |
| Maximal safe resection | Maximal safe resection of the contrast-enhancing part of the tumor Receives: Procedure: Maximal safe resection |
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 (15)
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
Onco-functional outcome
According to the OFO classification, consisting of the combination of presence/absence of functional deterioration with gross-total resection
Measured: 6 weeks 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 6 weeks (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Measured: 6 weeks 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 (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Measured: 3 months 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 3 months (EQ-5D)
Quality of life as assessed by the EQ-5D 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 months (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Measured: 6 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 posted7 Nov 2023
- Study start1 Jan 2022
- 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
- 784 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
- NCT06118723
- Sponsor's protocol ID
- MEC-2020-0812-2
- Acronym
- SUPRAMAX
- Status last verified
- Feb 2024
- First submitted
- 12 Oct 2023
- Last updated
- 22 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 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
- ClinicalTrials.gov ID
- NCT06118723
- Acronym / sponsor ID
- SUPRAMAX / MEC-2020-0812-2
- Conditions
- Glioblastoma, High-grade Glioma, Glioblastoma, IDH-wildtype, Glioblastoma, IDH-mutant, Glioblastoma Multiforme, Adult, Astrocytoma, Grade IV
- Keywords
- Glioblastoma, Supramaximal resection, FLAIRectomy, Non-contrast enhancement, Neurological morbidity, Quality of life, Overall survival, Progression-free survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 784 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 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 7 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.
A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively.
This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively.
The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).
Detailed description
This is an international, multicenter, prospective, observational, 2-arm cohort study (registration: clinicaltrials.gov ID number TBA). Eligible patients are operated with supramaximal resection versus maximal resection with a 1:3 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). Supramaximal resection is defined as 0 cm3 CE tumor and 5 cm3 or less NCE tumor, whereas maximal resection is defined as 0 cm3 CE tumor and >5 cm3 NCE tumor (in line with the updated RANO criteria).
Study patients are allocated to either the supramaximal or maximal safe resection group 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) 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. 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. 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 supramaximal resection versus safe maximal resection in HGG patients as measured by overall survival (OS) and postoperative NIHSS deterioration. Secondary study objectives are to evaluate extent of resection of CE and NCE tumor, quality of life, progression-free survival (PFS), onco-functional outcome (OFO), and SAEs after SMR or maximal safe resections as measured by volumetric analyses of contrast-enhanced MRI images with gadolinium combined with FLAIR images, tumor progression on MRI scans, quality of life questionnaires (EORTC QLQ C30, EORTC QLQ BN20, EQ 5D), combining postoperative residual volume with NIHSS outcomes, and recording SAEs respectively.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supramaximal resection | – | Procedure: Supramaximal resectionSupramaximal resection: maximal resection of the contrast-enhancing and non-contrast-enhancing part of the tumor (FLAIRectomy) |
| Maximal safe resection | – | Procedure: Maximal safe resectionMaximal safe resection of the contrast-enhancing part of the tumor |
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 (6 listed)
- Tumors of the cerebellum, brainstem or midline
- Multifocal contrast enhancing lesions
- 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
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 |
|---|---|---|
| Supramaximal resectionAlso: Supramarginal resection, FLAIRectomy, Resection of the non-contrast-enhancing tumorSupramaximal resection. Tumor resection continues until either the FLAIR abnormalities have been resected based on the neuronavigation (after updating the navigation intraoperatively), or when subcortical tracts are identified with intraoperative stimulation. | Procedure or surgery | Supramaximal resection |
| Maximal safe resectionMaximal safe resection. Tumor resection continues until maximal safe resection has been achieved as by the neurosurgeon's opinion. | Procedure or surgery | Maximal safe resection |
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
15 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
Onco-functional outcome
Time frame: 6 weeks postoperatively
Quality of life at 6 weeks (EORTC QLQ C30)
Time frame: 6 weeks postoperatively
Quality of life at 6 weeks (EORTC QLQ BN20)
Time frame: 6 weeks postoperatively
Quality of life at 6 weeks (EQ-5D)
Time frame: 6 weeks postoperatively
Quality of life at 3 months (EORTC QLQ C30)
Time frame: 3 months postoperatively
Quality of life at 3 months (EORTC QLQ BN20)
Time frame: 3 months postoperatively
Quality of life at 3 months (EQ-5D)
Time frame: 3 months postoperatively
Quality of life at 6 months (EORTC QLQ C30)
Time frame: 6 months postoperatively
Quality of life at 6 months (EORTC QLQ BN20)
Time frame: 6 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 22 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 High-grade Glioma, 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 6 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 22 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 22 Feb 2024.