- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06273176
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma (RECMAP)
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2301)
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).
Study Overview
Status
Conditions
Detailed Description
This is an international, multicenter, prospective, 3-arm cohort study. Eligible patients are operated with or without mapping techniques with a 1:1 ratio with a sequential computer-generated random number as subject ID. Patients with motor-eloquent tumors will be treated in all study arms, while speech-eloquent tumors will only be treated in either the awake mapping or no mapping arm. The RECMAP study is similar to the SAFE-trial24 (awake craniotomy versus craniotomy under general anesthesia for glioblastoma patients, NCT03861299) and is initiated by the same center, however, the presented study will be different in various ways: the RECMAP study (1) will be an observational, prospective cohort study, (2) will include asleep mapping as an additional treatment arm, (3) will evaluate the extent of resection of the non-contrast-enhancing part of the tumor as well, (4) only includes recurrent tumors (5) will include neurosurgical centers in the United States and is part of the ENCRAM Research Consortium18. The RECMAP study is also similar to the PROGRAM study25 (awake mapping versus asleep mapping versus no mapping for high-grade glioma patients, NCT04708171), with the difference that the RECMAP study includes recurrent tumors (while the PROGRAM study includes newly diagnosed tumors), and that the RECMAP study includes recurrent glioblastoma, while the PRGORAM study includes WHO grade 3 and 4 gliomas.
Study patients are operated with either awake mapping, asleep mapping or no mapping and will undergo evaluation at presentation (baseline) and during the follow-up period at 6 weeks, 3 months, and 6 months postoperatively. Motor function will be evaluated using the NIHSS (National Institute of Health Stroke Scale) and MRC (Medical Research Council) scales. Language function will be evaluated using a standard neurolinguistic test-battery consisting of the Aphasia Bedside Check (ABC), Shortened Token test, Verbal fluency, Picture description and Object naming. This neurolinguistic test-battery is the result of a consensus between the participating centers. Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). Overall patient functioning with be assessed with the Karnofsky Performance Scale (KPS) and the ASA (American Society of Anesthesiologists) physical status classification system for comorbidities. Health-related quality of life (HRQoL) will be assessed with the EQ-5D questionnaire and the EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Overall survival and progression-free survival will be assessed. We expect to complete patient inclusion in 4 years. The estimated duration of the study, including follow-up, will be 5 years.
The primary study objective is to evaluate the safety and efficacy of resections with or without mapping techniques (neurological morbidity and residual CE and NCE tumor volume) in recurrent glioblastoma patients as expressed by NIHSS scores and volumetric data. Secondary study objectives are to study the overall survival (OS), progressive-free survival (PFS), health-related quality of life (HRQoL), and Serious Adverse Events (SAEs) after resections with or without mapping techniques as expressed by survival data, progression on follow up MRI scans based on the RANO criteria26 for tumor progression, quality of life questionnaires (EORTC QLQ C30, EORTC QLQ BN20, EQ-5D), and registration of SAEs.
Patients will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals, located in Europe and the United States. The study is carried out by centers from the ENCRAM Consortium.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jasper Gerritsen, MD PhD
- Phone Number: +31107036130
- Email: j.gerritsen@erasmusmc.nl
Study Contact Backup
- Name: Arnaud Vincent, MD PhD
- Phone Number: +31107034211
- Email: a.vincent@erasmusmc.nl
Study Locations
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Leuven, Belgium
- Recruiting
- University Hospital Leuven
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Contact:
- Steven De Vleeschouwer, MD PhD
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Heidelberg, Germany
- Recruiting
- Universitätsklinikum Heidelberg
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Contact:
- Christine Jungk, MD PhD
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Contact:
- Sandro Krieg, MD PhD
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Munich, Germany
- Not yet recruiting
- Technical University Munich
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Contact:
- Arthur Wagner, MD
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The Hague, Netherlands
- Recruiting
- Haaglanden Medical Center
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Contact:
- Marike Broekman, MD PhD
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Zuid-Holland
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Rotterdam, Zuid-Holland, Netherlands, 3015 GD
- Recruiting
- Erasmus Medical Center
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Contact:
- Jasper Gerritsen, MD PhD
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Bern, Switzerland
- Not yet recruiting
- INSELSPITAL Universitatsspital Bern
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Contact:
- Philippe Schucht, MD PhD
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California
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San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco
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Contact:
- Mitchel Berger, MD PhD
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
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Contact:
- Brian Nahed, MD PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Awake mapping
Awake mapping: Tumor resection with intraoperative awake motor or language mapping
|
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.
Other Names:
|
Asleep mapping
Asleep mapping: Tumor resection with intraoperative asleep motor mapping
|
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.
Other Names:
|
No mapping
No mapping: Tumor resection without intraoperative mapping
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During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological morbidity at 6 weeks
Time Frame: 6 weeks postoperatively
|
NIHSS deterioration of 1 point or more at 6 weeks after surgery
|
6 weeks postoperatively
|
Residual volume
Time Frame: Within 72 hours postoperatively
|
Residual tumor volume of the contrast-enhancing and non-contrast enhancing part, as assessed by a neuroradiologist on postoperative MRI scan (T1 with contrast and FLAIR sequences) using manual or semi-automatic volumetric analyses (Brainlab Elements iPlan CMF Segmentation, Brainlab AG, Munich, Germany; or similar software)
|
Within 72 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological morbidity at 3 months
Time Frame: 3 months postoperatively
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NIHSS deterioration of 1 point or more at 3 months after surgery
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3 months postoperatively
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Neurological morbidity at 6 months
Time Frame: 6 months postoperatively
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NIHSS deterioration of 1 point or more at 6 months after surgery
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6 months postoperatively
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Progression-free survival
Time Frame: Up to 5 years postoperatively
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Time from diagnosis to disease progression (occurrence of a new tumor lesions with a volume greater than 0.175 cm3, or an increase in residual tumor volume of more than 25%) or death, whichever comes first
|
Up to 5 years postoperatively
|
Quality of life at 6 weeks (EORTC QLQ C30)
Time Frame: 6 weeks postoperatively
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Quality of life as assessed by the EORTC QLQ C30 questionnaire
|
6 weeks postoperatively
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Quality of life at 6 weeks (EORTC QLQ BN20)
Time Frame: 6 weeks postoperatively
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Quality of life as assessed by the EORTC QLQ BN20 questionnaire
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6 weeks postoperatively
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Quality of life at 6 weeks (EQ-5D)
Time Frame: 6 weeks postoperatively
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Quality of life as assessed by the EQ-5D questionnaire
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6 weeks postoperatively
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Quality of life at 3 months (EORTC QLQ C30)
Time Frame: 3 months postoperatively
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Quality of life as assessed by the EORTC QLQ C30 questionnaire
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3 months postoperatively
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Quality of life at 3 months (EORTC QLQ BN20)
Time Frame: 3 months postoperatively
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Quality of life as assessed by the EORTC QLQ BN20 questionnaire
|
3 months postoperatively
|
Quality of life at 3 months (EQ-5D)
Time Frame: 3 months postoperatively
|
Quality of life as assessed by the EQ-5D questionnaire
|
3 months postoperatively
|
Quality of life at 6 months (EORTC QLQ C30)
Time Frame: 6 months postoperatively
|
Quality of life as assessed by the EORTC QLQ C30 questionnaire
|
6 months postoperatively
|
Quality of life at 6 months (EORTC QLQ BN20)
Time Frame: 6 months postoperatively
|
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
|
6 months postoperatively
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Quality of life at 6 months (EQ-5D)
Time Frame: 6 months postoperatively
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Quality of life as assessed by the EQ-5D questionnaire
|
6 months postoperatively
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Serious Adverse Events
Time Frame: 6 weeks postoperatively
|
Serious Adverse Events within 6 weeks postoperatively
|
6 weeks postoperatively
|
Overall survival
Time Frame: Up to 5 years postoperatively
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Time from diagnosis to death from any cause.
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Up to 5 years postoperatively
|
Onco-functional outcome (OFO)
Time Frame: 6 weeks postoperatively
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According to the OFO classification, consisting of the combination of presence/absence of functional deterioration with gross-total resection
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6 weeks postoperatively
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Overall functioning at 6 weeks
Time Frame: 6 weeks postoperatively
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KPS deterioration at 6 weeks after surgery
|
6 weeks postoperatively
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Overall functioning at 3 months
Time Frame: 6 months postoperatively
|
KPS deterioration at 3 months after surgery
|
6 months postoperatively
|
Overall functioning at 6 months
Time Frame: 6 months postoperatively
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KPS deterioration at 6 months after surgery
|
6 months postoperatively
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jasper Gerritsen, MD PhD, Erasmus Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms
- Glioblastoma
- Recurrence
- Brain Neoplasms
- Astrocytoma
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics
Other Study ID Numbers
- MEC-2020-0812
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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