Investigating survival, quality of life and cognition in PROton versus photon therapy for IDH-mutated diffuse grade 2 and 3 GLIOmas (PRO-GLIO): a randomised controlled trial in Norway and Sweden
Introduction
The use of proton therapy increases globally despite a lack of randomised controlled trials demonstrating its efficacy and safety. Proton therapy enables sparing of non-neoplastic tissue from radiation. This is principally beneficial and holds promise of reduced long-term side effects. However, the sparing of seemingly non-cancerous tissue is not necessarily positive for isocitrate dehydrogenase (IDH)-mutated diffuse gliomas grade 2–3, which have a diffuse growth pattern. With their relatively good prognosis, yet incurable nature, therapy needs to be delicately balanced to achieve a maximal survival benefit combined with an optimised quality of life.
Methods and analysis
PRO-GLIO (PROton versus photon therapy in IDH-mutated diffuse grade 2 and 3 GLIOmas) is an open-label, multicentre, randomised phase III non-inferiority study. 224 patients aged 18–65 years with IDH-mutated diffuse gliomas grade 2–3 from Norway and Sweden will be randomised 1:1 to radiotherapy delivered with protons (experimental arm) or photons (standard arm). First intervention-free survival at 2 years is the primary endpoint. Key secondary endpoints are fatigue and cognitive impairment, both at 2 years. Additional secondary outcomes include several survival measures, health-related quality of life parameters and health economy endpoints.
Ethics and dissemination
To implement proton therapy as part of standard of care for patients with IDH-mutated diffuse gliomas grade 2&nda...
Source: BMJ Open - Category: General Medicine Authors: Heggebo, L. C., Borgen, I. M. H., Rylander, H., Kiserud, C., Nordenmark, T. H., Hellebust, T. P., Evensen, M. E., Gustavsson, M., Ramberg, C., Sprauten, M., Magelssen, H., Blakstad, H., Moorthy, J., Andersson, K., Raunert, I., Henry, T., Moe, C., Granlund Tags: Open access, Oncology Source Type: research
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