The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma

Recruiting now

Conditions studied: Glioblastoma, IDH-wildtype, Glioblastoma, Glioblastoma Multiforme of Brain, Astrocytoma, Malignant, Brain Neoplasms, Brain Neoplasms, Adult, Malignant, Brain Neoplasms, Adult, Recurrent Adult Brain Tumor, Recurrent Glioblastoma

In brief

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).

Key facts

Study ID

NCT06273176

Run by

Erasmus Medical Center

People needed

225

Starts

2023-01-01

Expected to finish

2028-01-01

Last updated by the study team

2024-02-22

Who can join

Age: any, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Tumors of the cerebellum, brainstem, or midline
• Multifocal contrast-enhancing lesions
• Medical reasons precluding MRI (e.g., pacemaker)
• Inability to give written informed consent
• Secondary high-grade glioma due to malignant transformation from low-grade glioma
• Clinical data unavailable for the newly diagnosed setting

Where it is running

• Haaglanden Medical Center — The Hague, Netherlands (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• University Hospital Leuven — Leuven, Belgium (enrolling)
• Universitätsklinikum Heidelberg — Heidelberg, Germany (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Erasmus Medical Center — Rotterdam, South Holland, Netherlands (enrolling)
• Inselspital Universitätsspital Bern — Bern, Switzerland
• Technical University Munich — Munich, Germany

Full record on ClinicalTrials.gov

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