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The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
Sponsor: Erasmus Medical Center
Summary
Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma. This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).
Official title: The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2301)
Key Details
Gender
All
Age Range
Any - 90 Years
Study Type
OBSERVATIONAL
Enrollment
225
Start Date
2023-01-01
Completion Date
2028-01-01
Last Updated
2024-02-22
Healthy Volunteers
No
Conditions
Interventions
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
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
During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.
Locations (8)
University of California, San Francisco
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University Hospital Leuven
Leuven, Belgium
Universitätsklinikum Heidelberg
Heidelberg, Germany
Technical University Munich
Munich, Germany
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Haaglanden Medical Center
The Hague, Netherlands
Inselspital Universitätsspital Bern
Bern, Switzerland