Repeat resection in recurrent glioblastoma (3rGBM) Trial: A randomized care trial.


Journal

Neuro-Chirurgie
ISSN: 1773-0619
Titre abrégé: Neurochirurgie
Pays: France
ID NLM: 0401057

Informations de publication

Date de publication:
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

262-266

Informations de copyright

Copyright © 2021 Elsevier Masson SAS. All rights reserved.

Auteurs

M Patel (M)

Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada.

K Au (K)

Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada.

J C Easaw (JC)

Department of Oncology, Faculty of Medicine, Cross Cancer Institute, 11560 University Ave, University of Alberta, T6G 1Z2, Alberta, Edmonton, Canada.

F G Davis (FG)

School of Public Health, University of Alberta, T6G 2R3, Alberta, Edmonton, Canada.

K Young (K)

Department of Oncology, Faculty of Medicine, Cross Cancer Institute, 11560 University Ave, University of Alberta, T6G 1Z2, Alberta, Edmonton, Canada.

V Mehta (V)

Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada.

G N Bowden (GN)

Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada.

M B Keough (MB)

Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada.

T Sankar (T)

Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada.

F Scholtes (F)

Departments of Neuroanatomy and Neurosurgery, University of Liège and CHU Liège, Liège, Belgium.

M Chagnon (M)

Department of Mathematics and Statistics, Pavillon André-Aisenstadt (AA-5190), 2920, chemin de la Tour, H3T 1J4, Montreal, Quebec, Canada.

G L'Espérance (G)

Dying with Dignity Canada, and Division of Neurosurgery, Department of Surgery, Université de Montréal, Montréal, Canada.

Y Yuan (Y)

School of Public Health, University of Alberta, T6G 2R3, Alberta, Edmonton, Canada.

G Gevry (G)

Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), 1000 St-Denis street, room D03.5462B, H2X 0C1, Montreal, Quebec, Canada.

J Raymond (J)

Department of Radiology, Centre Hospitalier de l'Université de Montréal (CHUM), 1000 St-Denis street, room D03.5462B, H2X 0C1, Montreal, Quebec, Canada.

T E Darsaut (TE)

Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada. Electronic address: tdarsaut@ualberta.ca.

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Classifications MeSH