The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2301)

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 90
Healthy Volunteers: f
View:

• Age ≥18 years and ≤90 years

• Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma

• 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)19

• The tumor is suitable for resection (according to neurosurgeon)

• Written informed consent

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Other Locations
Belgium
University Hospital Leuven
RECRUITING
Leuven
Germany
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Technical University Munich
NOT_YET_RECRUITING
Munich
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Haaglanden Medical Center
RECRUITING
The Hague
Switzerland
Inselspital Universitätsspital Bern
NOT_YET_RECRUITING
Bern
Contact Information
Primary
Jasper Gerritsen, MD PhD
j.gerritsen@erasmusmc.nl
+31107036130
Backup
Arnaud Vincent, MD PhD
a.vincent@erasmusmc.nl
+31107034211
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 225
Treatments
Awake mapping
Awake mapping: Tumor resection with intraoperative awake motor or language mapping
Asleep mapping
Asleep mapping: Tumor resection with intraoperative asleep motor mapping
No mapping
No mapping: Tumor resection without intraoperative mapping
Sponsors
Collaborators: Massachusetts General Hospital, Universitaire Ziekenhuizen KU Leuven, Insel Gruppe AG, University Hospital Bern, Technical University of Munich, University of California, San Francisco, Haaglanden Medical Centre, University Hospital Heidelberg
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov