Repeat resection in recurrent glioblastoma (3rGBM) Trial: A randomized care trial.
Care trial
Obstacles to RCTs
Randomized controlled trial
Recurrent Glioblastoma
Journal
Neuro-Chirurgie
ISSN: 1773-0619
Titre abrégé: Neurochirurgie
Pays: France
ID NLM: 0401057
Informations de publication
Date de publication:
Apr 2022
Apr 2022
Historique:
received:
02
08
2021
revised:
30
08
2021
accepted:
04
09
2021
pubmed:
18
9
2021
medline:
6
5
2022
entrez:
17
9
2021
Statut:
ppublish
Résumé
The prognosis for patients with recurrent glioblastoma (GBM) is dismal, and the question of repeat surgery at time of recurrence is common. Re-operation in the management of these patients remains controversial, as there is no randomized evidence of benefit. An all-inclusive pragmatic care trial is needed to evaluate the role of repeat resection. 3rGBM is a multicenter, pragmatic, prospective, parallel-group randomized care trial, with 1:1 allocation to repeat resection or standard care with no repeat resection. To test the hypothesis that repeat resection can improve overall survival by at least 3 months (from 6 to 9 months), 250 adult patients with prior resection of pathology-proven glioblastoma for whom the attending surgeon believes repeat resection may improve quality survival will be enrolled. A surrogate measure of quality of life, the number of days outside of hospital/nursing/palliative care facility, will also be compared. Centers are invited to participate without financial compensation and without contracts. Clinicians may apply to local authorities to approve an investigator-led in-house trial, using a common protocol, web-based randomization platform, and simple standardized case report forms. The 3rGBM trial is a modern transparent care research framework with no additional risks, tests, or visits other than what patients would encounter in normal care. The burden of proof remains on repeat surgical management of recurrent GBM, because this management has yet to be shown beneficial. The trial is designed to help patients and surgeons manage the uncertainty regarding optimal care. http://www. gov. Unique identifier: NCT04838782.
Sections du résumé
BACKGROUND
BACKGROUND
The prognosis for patients with recurrent glioblastoma (GBM) is dismal, and the question of repeat surgery at time of recurrence is common. Re-operation in the management of these patients remains controversial, as there is no randomized evidence of benefit. An all-inclusive pragmatic care trial is needed to evaluate the role of repeat resection.
METHODS
METHODS
3rGBM is a multicenter, pragmatic, prospective, parallel-group randomized care trial, with 1:1 allocation to repeat resection or standard care with no repeat resection. To test the hypothesis that repeat resection can improve overall survival by at least 3 months (from 6 to 9 months), 250 adult patients with prior resection of pathology-proven glioblastoma for whom the attending surgeon believes repeat resection may improve quality survival will be enrolled. A surrogate measure of quality of life, the number of days outside of hospital/nursing/palliative care facility, will also be compared. Centers are invited to participate without financial compensation and without contracts. Clinicians may apply to local authorities to approve an investigator-led in-house trial, using a common protocol, web-based randomization platform, and simple standardized case report forms.
DISCUSSION
CONCLUSIONS
The 3rGBM trial is a modern transparent care research framework with no additional risks, tests, or visits other than what patients would encounter in normal care. The burden of proof remains on repeat surgical management of recurrent GBM, because this management has yet to be shown beneficial. The trial is designed to help patients and surgeons manage the uncertainty regarding optimal care.
CLINICAL TRIAL REGISTRATION
BACKGROUND
http://www.
CLINICALTRIALS
RESULTS
gov. Unique identifier: NCT04838782.
Identifiants
pubmed: 34534565
pii: S0028-3770(21)00204-6
doi: 10.1016/j.neuchi.2021.09.001
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04838782']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
262-266Informations de copyright
Copyright © 2021 Elsevier Masson SAS. All rights reserved.