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
|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 Type :||Observational|
|Estimated Enrollment :||453 participants|
|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|
|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.
- 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
- 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.
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
|Contact: Jasper Gerritsen, MDemail@example.com|
|Contact: Arnaud Vincent, MD PhDfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Not yet recruiting|
|San Francisco, California, United States, 94143|
|Contact: Mitchel Berger, Dr. email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114-2696|
|Contact: Brian Nahed, Dr. firstname.lastname@example.org|
|University Hospitals Leuven||Not yet recruiting|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Contact: Prof. Steven De Vleeschouwer, MD PhD email@example.com|
|University Hospital Heidelberg||Not yet recruiting|
|Contact: Christine Jungk, Dr. med.|
|Technical University Munich||Not yet recruiting|
|Contact: Sandro Krieg, Prof. dr. med. firstname.lastname@example.org|
|Rotterdam, Zuid-Holland, Netherlands, 3015 CE|
|Contact: Arnaud Vincent, MD PhD +31639428949 email@example.com|
|Contact: Jasper Gerritsen, MD +31629119553 firstname.lastname@example.org|
|Medical Center Haaglanden||Not yet recruiting|
|The Hague, Zuid-Holland, Netherlands, 2261 CP|
|Contact: Marike Broekman, MD PhD +31639758253 email@example.com|
|Inselspital Universitätsspital Bern||Not yet recruiting|
|Contact: Philippe Schucht, Prof. dr. med. firstname.lastname@example.org|
|Sub-Investigator: Kathleen Seidel, Dr. med.|
|Study Director:||Jasper Gerritsen, MD||Erasmus Medical Center|