[en] 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: 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: 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: http://www.
CLINICALTRIALS: gov. Unique identifier: NCT04838782.
Disciplines :
Surgery Neurology Oncology
Author, co-author :
Patel, M; Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada
Au, K; Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada
Easaw, J C; Department of Oncology, Faculty of Medicine, Cross Cancer Institute, 11560 University Ave, University of Alberta, T6G 1Z2, Alberta, Edmonton, Canada
Davis, F G; School of Public Health, University of Alberta, T6G 2R3, Alberta, Edmonton, Canada
Young, K; Department of Oncology, Faculty of Medicine, Cross Cancer Institute, 11560 University Ave, University of Alberta, T6G 1Z2, Alberta, Edmonton, Canada
Mehta, V; Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada
Bowden, G N; Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada
Keough, M B; Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada
Sankar, T; Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, 8440 112St NW, T6G 2B7, Alberta, Edmonton, Canada
Scholtes, Félix ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Neuro-anatomie ; Centre Hospitalier Universitaire de Liège - CHU > > Service de neurochirurgie
Chagnon, M; Department of Mathematics and Statistics, Pavillon André-Aisenstadt (AA-5190), 2920, chemin de la Tour, H3T 1J4, Montreal, Quebec, Canada
L'Espérance, G; Dying with Dignity Canada, and Division of Neurosurgery, Department of Surgery, Université de Montréal, Montréal, Canada
Yuan, Y; School of Public Health, University of Alberta, T6G 2R3, Alberta, Edmonton, Canada
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
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
Darsaut, T E; 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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