The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
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. 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.
Arms & interventions
- ProcedureAwake mapping under local anesthesia
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.
- ProcedureAsleep mapping under general anesthesia
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.
- ProcedureResection under general anesthesia without mapping
During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.
Outcome measures
Primary
Neurological morbidity
NIHSS deterioration of 1 point or more as compared to baseline value.
Time frame: 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
Time frame: Assessed within 72 hours on postoperative MRI scan
Secondary
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
Eligibility criteria
Study locations (2)
University of California, San Francisco
San Francisco, California, 94143
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
References
- 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)
- 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.(PubMed)