GlioblastomaPROGRAMNCT04708171
The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
An observational study of Glioblastoma, run by Erasmus Medical Center at 8 sites in 5 countries.
Trial summary
The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Awake mapping under local anesthesia, Asleep mapping under general anesthesia and Resection under general anesthesia without mapping
- Type of treatment
- Surgery or procedure
- How many people
- 453 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 1 Jan 2022to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Adults with primary or recurrent glioblastoma (GBM).
Who may be able to join
- Age ≥18 years and ≤ 90 years
- Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon
- Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)
- The tumor is suitable for resection (according to neurosurgeon)
- Written informed consent
Who cannot join
- Tumors of the cerebellum, brain stem or midline
- Multifocal contrast enhancing lesions
- Medical reasons precluding MRI (e.g. pacemaker)
- Inability to give written informed consent (e.g. because of severe language barrier)
- 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.
Arnaud Vincent, MD PhD contact
8 sites in 5 countries
United States2 sites, 2 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
Brian Nahed, Dr., bnahed@mgh.harvard.edu
- Not yet recruiting
University of California, San Francisco
San Francisco, California, 94143
Mitchel Berger, Dr., mitchel.berger@ucsf.edu
Germany2 sites, 2 recruiting
- Not yet recruiting
University Hospital Heidelberg
Heidelberg
Christine Jungk, Dr. med.
- Not yet recruiting
Technical University Munich
Munich
Sandro Krieg, Prof. dr. med., sandro.krieg@tum.de
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
- Not yet recruiting
Medical Center Haaglanden
The Hague, South Holland, 2261 CP
Marike Broekman, MD PhD, +31639758253, m.broekman@haaglandenmc.nl
Belgium1 site, 1 recruiting
- Not yet recruiting
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Prof. Steven De Vleeschouwer, MD PhD, steven.devleeschouwer@uzleuven.be
Switzerland1 site, 1 recruiting
- Not yet recruiting
Inselspital Universitätsspital Bern
Bern
Philippe Schucht, Prof. dr. med., philippe.schucht@insel.ch
Kathleen Seidel, Dr. med.
About this study
The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the "awake" mapping technique (awake craniotomy, AC); 2) a craniotomy where the resection boundaries for motor functions will be identified by "asleep" mapping techniques (MEPs, SSEPs, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique ("no mapping group"). All patients will receive follow-up according to standard practice.
- Conditions
- Glioblastoma
- Being tested
- Awake mapping under local anesthesia, Asleep mapping under general anesthesia, Resection under general anesthesia without mapping
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake mapping under local anesthesiaProcedure or surgery
During an awake craniotomy, the patient is awake and cooperative during the resection of the tumor while the surgeon uses electro(sub)cortical mapping to prevent damage to eloquent areas.
Asleep mapping under general anesthesiaProcedure or surgery
During asleep mapping under general anesthesia, the surgeon uses electro(sub)cortical mapping with evoked potentials (MEPs, SSEPs or continuous dynamic mapping) to prevent damage to eloquent areas.
Resection under general anesthesia without mappingProcedure or surgery
During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.
| Study group | Role | What they receive |
|---|---|---|
| Awake mapping under local anesthesia | Not described Receives: Procedure: Awake mapping under local anesthesia | |
| Asleep mapping under general anesthesia | Not described Receives: Procedure: Asleep mapping under general anesthesia | |
| Resection under general anesthesia without mapping | Not described Receives: Procedure: Resection under general anesthesia without mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological morbidity
NIHSS deterioration of 1 point or more as compared to baseline value.
Measured: Between baseline and 6 weeks/3 months/6 months postoperatively
Extent of resection
Resection percentage as assessed by an independent neuroradiologist on MRI contrast images with volumetric analysis
Measured: Assessed within 72 hours on postoperative MRI scan
Secondary outcomes (6)
Progression-free survival
Progression-free survival (PFS) defined as time from diagnosis to disease progression (occurrence of a new tumour lesion with a volume greater than 0.175 cm³, or an increase in residual tumour volume of more than 25%) or death, whichever comes first.
Measured: Between surgery and 12 months postoperatively
Overall survival
Overall survival (OS) defined as time from diagnosis to death from any cause.
Measured: Between surgery and 12 months postoperatively
Onco-functional outcome
2D coordinate based on extent of resection (or residual tumor volume) on the x-axis and NIHSS score on the y-axis
Measured: Between baseline and 6 weeks/3 months/6 months postoperatively
Frequency and severity of Serious Adverse Events (SAEs)
Infections, intracerebral bleeding, epilepsy, aphasia, paresis/paralysis in arms or/and legs (this is not an exhaustive list).
Measured: Between surgery and 6 weeks postoperatively
Residual tumor volume
Postoperative tumor volume in mm3 as assessed by an independent neuroradiologist on MRI contrast images with volumetric analysis
Measured: Assessed within 72 hours on postoperative MRI scan
MRC deterioration (for motor gliomas)
MRC deterioration of 1 point or more as compared to baseline value.
Measured: Between baseline and 6 weeks/3 months/6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jan 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- 453 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Center Haaglanden, Universitaire Ziekenhuizen KU Leuven, University of California, San Francisco
- Responsible party
- Principal investigator, Jasper Gerritsen, Erasmus Medical Center
- Investigators
- Jasper Gerritsen, MD, Study director, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708171
- Sponsor's protocol ID
- MEC-2020-081-2
- Acronym
- PROGRAM
- Status last verified
- May 2022
- First submitted
- 26 Nov 2020
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerritsen JKW, Zwarthoed RH, Kilgallon JL, Nawabi NL, Jessurun CAC, Versyck G, Pruijn KP, Fisher FL, Lariviere E, Solie L, Mekary RA, Satoer DD, Schouten JW, Bos EM, Kloet A, Nandoe Tewarie R, Smith TR, Dirven CMF, De Vleeschouwer S, Broekman MLD, Vincent AJPE. Effect of awake craniotomy in glioblastoma in eloquent areas (GLIOMAP): a propensity score-matched analysis of an international, multicentre, cohort study. Lancet Oncol. 2022 Jun;23(6):802-817. doi: 10.1016/S1470-2045(22)00213-3. Epub 2022 May 12.
PubMed 35569489Gerritsen JKW, Dirven CMF, De Vleeschouwer S, Schucht P, Jungk C, Krieg SM, Nahed BV, Berger MS, Broekman MLD, Vincent AJPE. The PROGRAM study: awake mapping versus asleep mapping versus no mapping for high-grade glioma resections: study protocol for an international multicenter prospective three-arm cohort study. BMJ Open. 2021 Jul 21;11(7):e047306. doi: 10.1136/bmjopen-2020-047306.
PubMed 34290067
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
- ClinicalTrials.gov ID
- NCT04708171
- Acronym / sponsor ID
- PROGRAM / MEC-2020-081-2
- Conditions
- Glioblastoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 453 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Medical Center Haaglanden, Universitaire Ziekenhuizen KU Leuven, University of California, San Francisco
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 Jan 2021 (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.
The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the "awake" mapping technique (awake craniotomy, AC); 2) a craniotomy where the resection boundaries for motor functions will be identified by "asleep" mapping techniques (MEPs, SSEPs, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique ("no mapping group"). All patients will receive follow-up according to standard practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Awake mapping under local anesthesia | – | Procedure: Awake mapping under local anesthesia |
| Asleep mapping under general anesthesia | – | Procedure: Asleep mapping under general anesthesia |
| Resection under general anesthesia without mapping | – | Procedure: Resection under general anesthesia without mapping |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with primary or recurrent glioblastoma (GBM).
Key inclusion criteria (5 listed)
- Age ≥18 years and ≤ 90 years
- Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon
- Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)
- The tumor is suitable for resection (according to neurosurgeon)
- Written informed consent
Key exclusion criteria (5 listed)
- Tumors of the cerebellum, brain stem or midline
- Multifocal contrast enhancing lesions
- Medical reasons precluding MRI (e.g. pacemaker)
- Inability to give written informed consent (e.g. because of severe language barrier)
- 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 |
|---|---|---|
| Awake mapping under local anesthesiaDuring an awake craniotomy, the patient is awake and cooperative during the resection of the tumor while the surgeon uses electro(sub)cortical mapping to prevent damage to eloquent areas. | Procedure or surgery | Awake mapping under local anesthesia |
| Asleep mapping under general anesthesiaDuring asleep mapping under general anesthesia, the surgeon uses electro(sub)cortical mapping with evoked potentials (MEPs, SSEPs or continuous dynamic mapping) to prevent damage to eloquent areas. | Procedure or surgery | Asleep mapping under general anesthesia |
| Resection under general anesthesia without mappingDuring resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas. | Procedure or surgery | Resection under general anesthesia without mapping |
Primary outcome
Neurological morbidity
Time frame: Between baseline and 6 weeks/3 months/6 months postoperatively
NIHSS deterioration of 1 point or more as compared to baseline value.
Extent of resection
Time frame: Assessed within 72 hours on postoperative MRI scan
Resection percentage as assessed by an independent neuroradiologist on MRI contrast images with volumetric analysis
6 secondary outcomes
Progression-free survival
Time frame: Between surgery and 12 months postoperatively
Overall survival
Time frame: Between surgery and 12 months postoperatively
Onco-functional outcome
Time frame: Between baseline and 6 weeks/3 months/6 months postoperatively
Frequency and severity of Serious Adverse Events (SAEs)
Time frame: Between surgery and 6 weeks postoperatively
Residual tumor volume
Time frame: Assessed within 72 hours on postoperative MRI scan
MRC deterioration (for motor gliomas)
Time frame: Between baseline and 6 weeks/3 months/6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Derived from this study: PubMed 35569489Gerritsen JKW, Zwarthoed RH, Kilgallon JL, Nawabi NL, Jessurun CAC, Versyck G, Pruijn KP, Fisher FL, Lariviere E, Solie L, Mekary RA, Satoer DD, Schouten JW, Bos EM, Kloet A, Nandoe Tewarie R, Smith TR, Dirven CMF, De Vleeschouwer S, Broekman MLD, Vincent AJPE. Effect of awake craniotomy in glioblastoma in eloquent areas (GLIOMAP): a propensity score-matched analysis of an international, multicentre, cohort study. Lancet Oncol. 2022 Jun;23(6):802-817. doi: 10.1016/S1470-2045(22)00213-3. Epub 2022 May 12.
- Derived from this study: PubMed 34290067Gerritsen JKW, Dirven CMF, De Vleeschouwer S, Schucht P, Jungk C, Krieg SM, Nahed BV, Berger MS, Broekman MLD, Vincent AJPE. The PROGRAM study: awake mapping versus asleep mapping versus no mapping for high-grade glioma resections: study protocol for an international multicenter prospective three-arm cohort study. BMJ Open. 2021 Jul 21;11(7):e047306. doi: 10.1136/bmjopen-2020-047306.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Arnaud Vincent, MD PhD contact
Jasper Gerritsen, MD study director
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, run by Erasmus Medical Center 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 5 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: status not confirmed, as of the sponsor's last update on 6 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasper Gerritsen, MD (+31629119553, j.gerritsen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological morbidity (time frame: Between baseline and 6 weeks/3 months/6 months 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 NCT04708171, which also lists 2 linked publications.
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 6 May 2022.