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

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).

Conditions

• 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

Interventions

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.

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.

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.

Sponsors & Collaborators

• Haaglanden Medical Centre

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• University Hospital Heidelberg

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Jasper Gerritsen, MD PhD · Erasmus Medical Center

Eligibility

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2027-01-01

Completion

2028-01-01

Countries

• United States
• Belgium
• Germany
• Netherlands
• Switzerland

Study Locations