Montag, 29. April 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
RECMAP

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

Rekrutierend

NCT-Nummer:
NCT06273176

Studienbeginn:
Januar 2023

Letztes Update:
22.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms, Glioblastoma, Brain Neoplasms, Astrocytoma, Recurrence

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Erasmus Medical Center

Collaborator:
Haaglanden Medical Centre, Universitaire Ziekenhuizen KU Leuven, University Hospital Heidelberg, Technical University of Munich, Insel Gruppe AG, University Hospital Bern, Massachusetts General Hospital, University of California, San Francisco,

Studienleiter

Jasper Gerritsen, MD PhD
Principal Investigator
Erasmus Medical Center

Kontakt

Studienlocations
(3 von 8)

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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)

2. Neurological morbidity at 6 weeks (Time Frame - 6 weeks postoperatively):
NIHSS deterioration of 1 point or more at 6 weeks after surgery

Secondary outcome:

1. Overall survival (Time Frame - Up to 5 years postoperatively):
Time from diagnosis to death from any cause.

2. Progression-free survival (Time Frame - Up to 5 years postoperatively):
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

3. Onco-functional outcome (OFO) (Time Frame - 6 weeks postoperatively):
According to the OFO classification, consisting of the combination of presence/absence of functional deterioration with gross-total resection

4. Serious Adverse Events (Time Frame - 6 weeks postoperatively):
Serious Adverse Events within 6 weeks postoperatively

5. Neurological morbidity at 3 months (Time Frame - 3 months postoperatively):
NIHSS deterioration of 1 point or more at 3 months after surgery

6. Neurological morbidity at 6 months (Time Frame - 6 months postoperatively):
NIHSS deterioration of 1 point or more at 6 months after surgery

7. Overall functioning at 6 weeks (Time Frame - 6 weeks postoperatively):
KPS deterioration at 6 weeks after surgery

8. Overall functioning at 3 months (Time Frame - 6 months postoperatively):
KPS deterioration at 3 months after surgery

9. Overall functioning at 6 months (Time Frame - 6 months postoperatively):
KPS deterioration at 6 months after surgery

10. Quality of life at 6 weeks (EORTC QLQ C30) (Time Frame - 6 weeks postoperatively):
Quality of life as assessed by the EORTC QLQ C30 questionnaire

11. Quality of life at 3 months (EORTC QLQ C30) (Time Frame - 3 months postoperatively):
Quality of life as assessed by the EORTC QLQ C30 questionnaire

12. 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

13. Quality of life at 6 weeks (EORTC QLQ BN20) (Time Frame - 6 weeks postoperatively):
Quality of life as assessed by the EORTC QLQ BN20 questionnaire

14. Quality of life at 3 months (EORTC QLQ BN20) (Time Frame - 3 months postoperatively):
Quality of life as assessed by the EORTC QLQ BN20 questionnaire

15. 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

16. Quality of life at 6 weeks (EQ-5D) (Time Frame - 6 weeks postoperatively):
Quality of life as assessed by the EQ-5D questionnaire

17. Quality of life at 3 months (EQ-5D) (Time Frame - 3 months postoperatively):
Quality of life as assessed by the EQ-5D questionnaire

18. Quality of life at 6 months (EQ-5D) (Time Frame - 6 months postoperatively):
Quality of life as assessed by the EQ-5D questionnaire

Studien-Arme

  • 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

Geprüfte Regime

  • Awake mapping under local anesthesia (Awake craniotomy):
    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.
  • Asleep mapping under general anesthesia (Asleep motor mapping / Continous dynamic mapping / Evoked potentials / ):
    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.
  • 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.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

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

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.