The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
- Conditions
- Glioblastoma
- Interventions
- Procedure: Awake mapping under local anesthesiaProcedure: Asleep mapping under general anesthesiaProcedure: Resection under general anesthesia without mapping
- Registration Number
- NCT04708171
- Lead Sponsor
- Erasmus Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 453
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Awake mapping under local anesthesia Awake mapping under local anesthesia - Asleep mapping under general anesthesia Asleep mapping under general anesthesia - Resection under general anesthesia without mapping Resection under general anesthesia without mapping -
- Primary Outcome Measures
Name Time Method Extent of resection Assessed within 72 hours on postoperative MRI scan Resection percentage as assessed by an independent neuroradiologist on MRI contrast images with volumetric analysis
Neurological morbidity Between baseline and 6 weeks/3 months/6 months postoperatively NIHSS deterioration of 1 point or more as compared to baseline value.
- Secondary Outcome Measures
Name Time Method Overall survival Between surgery and 12 months postoperatively Overall survival (OS) defined as time from diagnosis to death from any cause.
Onco-functional outcome Between baseline and 6 weeks/3 months/6 months postoperatively 2D coordinate based on extent of resection (or residual tumor volume) on the x-axis and NIHSS score on the y-axis
Frequency and severity of Serious Adverse Events (SAEs) Between surgery and 6 weeks postoperatively Infections, intracerebral bleeding, epilepsy, aphasia, paresis/paralysis in arms or/and legs (this is not an exhaustive list).
Progression-free survival Between surgery and 12 months postoperatively 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.
MRC deterioration (for motor gliomas) Between baseline and 6 weeks/3 months/6 months postoperatively MRC deterioration of 1 point or more as compared to baseline value.
Residual tumor volume Assessed within 72 hours on postoperative MRI scan Postoperative tumor volume in mm3 as assessed by an independent neuroradiologist on MRI contrast images with volumetric analysis
Trial Locations
- Locations (8)
University Hospital Heidelberg
🇩🇪Heidelberg, Germany
Technical University Munich
🇩🇪Munich, Germany
Inselspital Universitätsspital Bern
🇨🇭Bern, Switzerland
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Erasmus MC
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Medical Center Haaglanden
🇳🇱The Hague, Zuid-Holland, Netherlands
University Hospitals Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium
University of California, San Francisco
🇺🇸San Francisco, California, United States