The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 1, 2025

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.

Arms, Groups and Cohorts

  • Awake mapping under local anesthesia
  • Asleep mapping under general anesthesia
  • Resection under general anesthesia without mapping

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Progression-free survival
    • Time Frame: 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.
  • Overall survival
    • Time Frame: Between surgery and 12 months postoperatively
    • Overall survival (OS) defined as time from diagnosis to death from any cause.
  • Onco-functional outcome
    • Time Frame: 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)
    • Time Frame: Between surgery and 6 weeks postoperatively
    • Infections, intracerebral bleeding, epilepsy, aphasia, paresis/paralysis in arms or/and legs (this is not an exhaustive list).
  • Residual tumor volume
    • Time Frame: 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
  • MRC deterioration (for motor gliomas)
    • Time Frame: Between baseline and 6 weeks/3 months/6 months postoperatively
    • MRC deterioration of 1 point or more as compared to baseline value.

Participating in This Clinical Trial

Inclusion Criteria

1. Age ≥18 years and ≤ 90 years 2. Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon 3. 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) 4. The tumor is suitable for resection (according to neurosurgeon) 5. Written informed consent Exclusion Criteria:

1. Tumors of the cerebellum, brain stem or midline 2. Multifocal contrast enhancing lesions 3. Medical reasons precluding MRI (e.g. pacemaker) 4. Inability to give written informed consent (e.g. because of severe language barrier) 5. 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erasmus Medical Center
  • Collaborator
    • Medical Center Haaglanden
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jasper Gerritsen, Principal Investigator – Erasmus Medical Center
  • Overall Official(s)
    • Jasper Gerritsen, MD, Study Director, Erasmus MC
  • Overall Contact(s)
    • Jasper Gerritsen, MD, +31629119553, j.gerritsen@erasmusmc.nl

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