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NCT Number: NCT04708171

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

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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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. Overall survival

    Time frame: Between surgery and 12 months postoperatively

    Overall survival (OS) defined as time from diagnosis to death from any cause.

  3. 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

  4. 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).

  5. 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

  6. 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.

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Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Medical Center Haaglanden
  • Universitaire Ziekenhuizen KU Leuven
  • University of California, San Francisco

Registry information

Acronym: PROGRAM

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 13, 2021
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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