NCT04708171

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
453

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
5 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jan 2022Oct 2026

First Submitted

Initial submission to the registry

November 26, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

3.8 years

First QC Date

November 26, 2020

Last Update Submit

May 5, 2022

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (2)

  • Neurological morbidity

    NIHSS deterioration of 1 point or more as compared to baseline value.

    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

    Assessed within 72 hours on postoperative MRI scan

Secondary Outcomes (6)

  • Progression-free survival

    Between surgery and 12 months postoperatively

  • Overall survival

    Between surgery and 12 months postoperatively

  • Onco-functional outcome

    Between baseline and 6 weeks/3 months/6 months postoperatively

  • Frequency and severity of Serious Adverse Events (SAEs)

    Between surgery and 6 weeks postoperatively

  • Residual tumor volume

    Assessed within 72 hours on postoperative MRI scan

  • +1 more secondary outcomes

Study Arms (3)

Awake mapping under local anesthesia

Procedure: Awake mapping under local anesthesia

Asleep mapping under general anesthesia

Procedure: Asleep mapping under general anesthesia

Resection under general anesthesia without mapping

Procedure: Resection under general anesthesia without mapping

Interventions

Awake mapping under local anesthesiaPROCEDURE

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.

Awake mapping under local anesthesia
Asleep mapping under general anesthesiaPROCEDURE

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.

Asleep mapping under general anesthesia
Resection under general anesthesia without mappingPROCEDURE

During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.

Resection under general anesthesia without mapping

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with primary or recurrent glioblastoma (GBM).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

NOT YET RECRUITING

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

NOT YET RECRUITING

University Hospital Heidelberg

Heidelberg, Germany

NOT YET RECRUITING

Technical University Munich

Munich, Germany

NOT YET RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015 CE, Netherlands

RECRUITING

Medical Center Haaglanden

The Hague, South Holland, 2261 CP, Netherlands

NOT YET RECRUITING

Inselspital Universitätsspital Bern

Bern, Switzerland

NOT YET RECRUITING

Related Publications (2)

  • 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.

    PMID: 35569489DERIVED

  • 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: 34290067DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Jasper Gerritsen, MD

    Erasmus Medical Center

    STUDY DIRECTOR

Central Study Contacts

Jasper Gerritsen, MD

CONTACT

+31629119553j.gerritsen@erasmusmc.nl

Arnaud Vincent, MD PhD

CONTACT

a.vincent@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2020

First Posted

January 13, 2021

Study Start

January 1, 2022

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)CH(1)US(2)NL(2)BE(1)