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- Heggebo, L. C., et al.
(författare)
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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
- 2023
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Ingår i: Bmj Open. - : BMJ. - 2044-6055. ; 13:3
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionThe 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 analysisPRO-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 disseminationTo implement proton therapy as part of standard of care for patients with IDH-mutated diffuse gliomas grade 2-3, it should be deemed safe. With its randomised controlled design testing proton versus photon therapy, PRO-GLIO will provide important information for this patient population concerning safety, cognition, fatigue and other quality of life parameters. As proton therapy is considerably more costly than its photon counterpart, cost-effectiveness will also be evaluated. PRO-GLIO is approved by ethical committees in Norway (Regional Committee for Medical & Health Research Ethics) and Sweden (The Swedish Ethical Review Authority) and patient inclusion has commenced. Trial results will be published in international peer-reviewed journals, relevant conferences, national and international meetings and expert forums.Trial registration numberClinicalTrials.gov Registry (NCT05190172).
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| 2. |
- Herique, A., et al.
(författare)
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Direct observations of asteroid interior and regolith structure : Science measurement requirements
- 2018
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Ingår i: Advances in Space Research. - : Elsevier BV. - 0273-1177 .- 1879-1948. ; 62:8, s. 2141-2162
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Tidskriftsartikel (refereegranskat)abstract
- Our knowledge of the internal structure of asteroids is, so far, indirect - relying entirely on inferences from remote sensing observations of the surface, and theoretical modeling of formation and evolution. What are the bulk properties of the regolith and deep interior? And what are the physical processes that shape asteroid internal structures? Is the composition and size distribution observed on the surface representative of the bulk? These questions are crucial to understand small bodies' history from accretion in the early Solar System to the present, and direct measurements are needed to answer these questions for the benefit of science as well as for planetary defense or exploration. Radar is one of the main instruments capable of sounding asteroids to characterize internal structure from sub-meter to global scale. In this paper, we review the science case for direct observation of the deep internal structure and regolith of a rocky asteroid of kilometer size or smaller. We establish the requirements and model dielectric properties of asteroids to outline a possible instrument suite, and highlight the capabilities of radar instrumentation to achieve these observations. We then review the expected science return including secondary objectives contributing to the determination of the gravitational field, the shape model, and the dynamical state. This work is largely inherited from MarcoPolo-R and AIDA/AIM studies.
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