Trial Title:
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
NCT ID:
NCT06273176
Condition:
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
Conditions: Official terms:
Neoplasms
Glioblastoma
Brain Neoplasms
Astrocytoma
Recurrence
Anesthetics
Conditions: Keywords:
Glioblastoma
Recurrent
Re-resection
Resection
Intraoperative mapping
Awake mapping
Awake craniotomy
Asleep mapping
Motor mapping
Language mapping
Overall survival
Progression-free survival
Neurological morbidity
Quality of life
Functional area
Eloquent
Extent of resection
Residual tumor volume
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Awake mapping under local anesthesia
Description:
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.
Arm group label:
Awake mapping
Other name:
Awake craniotomy
Intervention type:
Procedure
Intervention name:
Asleep mapping under general anesthesia
Description:
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.
Arm group label:
Asleep mapping
Other name:
Asleep motor mapping
Other name:
Continous dynamic mapping
Other name:
Evoked potentials
Intervention type:
Procedure
Intervention name:
Resection under general anesthesia without mapping
Description:
During resection under general anesthesia without mapping, the surgeon does not use any
intraoperative stimulation mapping techniques to identify eloquent areas.
Arm group label:
No mapping
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).
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.
Criteria for eligibility:
Study pop:
Patients with recurrent glioblastoma 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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥18 years and ≤90 years
2. Tumor recurrence according to the RANO criteria of a previously diagnosed
glioblastoma based on the WHO 2021 classification for glioma
3. 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
4. The tumor is suitable for resection (according to neurosurgeon)
5. Written informed consent
Exclusion Criteria:
1. Tumors of the cerebellum, brainstem, or midline
2. Multifocal contrast-enhancing lesions
3. Medical reasons precluding MRI (e.g., pacemaker)
4. Inability to give written informed consent
5. Secondary high-grade glioma due to malignant transformation from low-grade glioma
6. Clinical data unavailable for the newly diagnosed setting
Gender:
All
Minimum age:
N/A
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mitchel Berger, MD PhD
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Nahed, MD PhD
Facility:
Name:
University Hospital Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Steven De Vleeschouwer, MD PhD
Facility:
Name:
Universitätsklinikum Heidelberg
Address:
City:
Heidelberg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christine Jungk, MD PhD
Contact backup:
Last name:
Sandro Krieg, MD PhD
Facility:
Name:
Technical University Munich
Address:
City:
Munich
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Arthur Wagner, MD
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jasper Gerritsen, MD PhD
Facility:
Name:
Haaglanden Medical Center
Address:
City:
The Hague
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marike Broekman, MD PhD
Facility:
Name:
Inselspital Universitätsspital Bern
Address:
City:
Bern
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Philippe Schucht, MD PhD
Start date:
January 1, 2023
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Haaglanden Medical Centre
Agency class:
Other
Collaborator:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Collaborator:
Agency:
University Hospital Heidelberg
Agency class:
Other
Collaborator:
Agency:
Technical University of Munich
Agency class:
Other
Collaborator:
Agency:
Insel Gruppe AG, University Hospital Bern
Agency class:
Other
Collaborator:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
University of California, San Francisco
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06273176
