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| Name | Class |
|---|---|
| Medical Center Haaglanden | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| University of California, San Francisco | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Awake mapping under local anesthesia |
| ||
| Asleep mapping under general anesthesia |
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| Resection under general anesthesia without mapping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Awake mapping under local anesthesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological morbidity | NIHSS deterioration of 1 point or more as compared to baseline value. | 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 | Assessed within 72 hours on postoperative MRI scan |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between surgery and 12 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with primary or recurrent glioblastoma (GBM).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasper Gerritsen, MD | Contact | +31629119553 | j.gerritsen@erasmusmc.nl | |
| Arnaud Vincent, MD PhD | Contact | a.vincent@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jasper Gerritsen, MD | Erasmus Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Not yet recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35569489 | Derived | 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. | |
| 34290067 |
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| Asleep mapping under general anesthesia | Procedure | 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 mapping | Procedure | During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas. |
|
| Overall survival |
Overall survival (OS) defined as time from diagnosis to death from any cause. |
| 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 | 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). | 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 | 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. | Between baseline and 6 weeks/3 months/6 months postoperatively |
| Massachusetts General Hospital | Not yet recruiting | Boston | Massachusetts | 02114-2696 | United States |
|
| University Hospitals Leuven | Not yet recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| University Hospital Heidelberg | Not yet recruiting | Heidelberg | Germany |
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| Technical University Munich | Not yet recruiting | Munich | Germany |
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| Erasmus MC | Recruiting | Rotterdam | South Holland | 3015 CE | Netherlands |
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| Medical Center Haaglanden | Not yet recruiting | The Hague | South Holland | 2261 CP | Netherlands |
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| Inselspital Universitätsspital Bern | Not yet recruiting | Bern | Switzerland |
|
| Derived |
| Gerritsen 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. |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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