We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04708171
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : May 6, 2022
Sponsor:
Collaborators:
Medical Center Haaglanden
Universitaire Ziekenhuizen KU Leuven
University of California, San Francisco
Information provided by (Responsible Party):
Jasper Gerritsen, Erasmus Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Glioblastoma Procedure: Awake mapping under local anesthesia Procedure: Asleep mapping under general anesthesia Procedure: Resection under general anesthesia without mapping

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 453 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Awake mapping under local anesthesia 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.
Asleep mapping under general anesthesia 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.
Resection under general anesthesia without mapping 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with primary or recurrent glioblastoma (GBM).
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708171


Contacts
Layout table for location contacts
Contact: Jasper Gerritsen, MD +31629119553 j.gerritsen@erasmusmc.nl
Contact: Arnaud Vincent, MD PhD a.vincent@erasmusmc.nl

Locations
Layout table for location information
United States, California
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Mitchel Berger, Dr.       mitchel.berger@ucsf.edu   
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114-2696
Contact: Brian Nahed, Dr.       bnahed@mgh.harvard.edu   
Belgium
University Hospitals Leuven Not yet recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Prof. Steven De Vleeschouwer, MD PhD       steven.devleeschouwer@uzleuven.be   
Germany
University Hospital Heidelberg Not yet recruiting
Heidelberg, Germany
Contact: Christine Jungk, Dr. med.         
Technical University Munich Not yet recruiting
Munich, Germany
Contact: Sandro Krieg, Prof. dr. med.       sandro.krieg@tum.de   
Netherlands
Erasmus MC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Contact: Arnaud Vincent, MD PhD    +31639428949    a.vincent@erasmusmc.nl   
Contact: Jasper Gerritsen, MD    +31629119553    j.gerritsen@erasmusmc.nl   
Medical Center Haaglanden Not yet recruiting
The Hague, Zuid-Holland, Netherlands, 2261 CP
Contact: Marike Broekman, MD PhD    +31639758253    m.broekman@haaglandenmc.nl   
Switzerland
Inselspital Universitätsspital Bern Not yet recruiting
Bern, Switzerland
Contact: Philippe Schucht, Prof. dr. med.       philippe.schucht@insel.ch   
Sub-Investigator: Kathleen Seidel, Dr. med.         
Sponsors and Collaborators
Erasmus Medical Center
Medical Center Haaglanden
Universitaire Ziekenhuizen KU Leuven
University of California, San Francisco
Investigators
Layout table for investigator information
Study Director: Jasper Gerritsen, MD Erasmus Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jasper Gerritsen, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04708171    
Other Study ID Numbers: MEC-2020-081-2
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs