The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Awake mapping under local anesthesia, Asleep mapping under general anesthesia, Resection under general anesthesia without mapping.
- Who it may be relevant to
- Registry conditions: Glioblastoma. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Germany, Netherlands, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Awake 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. - Procedure Asleep 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. - Procedure Resection 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.
Primary outcome measures
- Neurological morbidity [Time frame: Between baseline and 6 weeks/3 months/6 months postoperatively]
- Extent of resection [Time frame: Assessed within 72 hours on postoperative MRI scan]
Secondary outcome measures (6)
- 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
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- University of California, San Francisco — San Francisco
- Massachusetts General Hospital — Boston
Germany · 2 centers
- University Hospital Heidelberg — Heidelberg
- Technical University Munich — Munich
Netherlands · 2 centers
- Erasmus MC — Rotterdam
- Medical Center Haaglanden — The Hague
Belgium · 1 center
- University Hospitals Leuven — Leuven
Switzerland · 1 center
- Inselspital Universitätsspital Bern — Bern
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, multicent PMID 35569489
- 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. PMID 34290067
Identifiers
NCT: NCT04708171 · MEC-2020-081-2