Journal Article

Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COG-PROTON-01)

Stefan, Dinu, PHRC-K 20–110, Hôpital d'instruction des Armées Percy ; Service de Santé des Armées, Lange, Marie, INCa-DGOS_15471, Valable, Samuel, The Arctic University of Norway [Tromsø, Norway] (UiT), Legrand, Berenice, Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques (CRESS (U1153 / UMR_A 1125)) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Castera, Marie, Noel, Georges, Service de recherche clinique [Centre François Baclesse] ; Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC) ; Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Clarisse, Benedicte, Balosso, Jacques, Ricard, Damien, Hospices Civils de Lyon (HCL), Imagerie et Stratégies Thérapeutiques pour les Cancers et Tis

2024

Overview

Background Proton therapy (PRT) is an innovative radiotherapeutic modality for the treatment of cancer with unique ballistic properties. The depth-dose distribution of a proton beam reduces exposure of healthy tissues to radiations, compared with photon-therapy (XRT). To date, only few indications for proton-therapy, like pediatric cancers, chordomas, or intra-ocular neoplasms, are reimbursed by Health systems. There is no published or recruiting prospective study evaluating the impact of proton-therapy or conventional irradiation on neurocognitive function for meningioma patients. Notably, long-term cognitive or ocular impact of these modern irradiation schemes remains poorly known. Yet, these patients had a long life-expectancy, and are at risk of developing long-term sequelae. Thus, according to its ballistic advantage, an improvement of patient functional outcomes and a reduction of neurocognitive long-term toxicity are expected if tissue sparing proton-therapy is used .Randomized trial seems crucial to further assess proton-therapy indication for patients with cavernous sinus meningioma.Methods COG-PROTON-01 is the first worldwide randomized phase III prospective study evaluating long-term toxicity of these two irradiation modalities (PRT and XRT)for the treatment of cavernous sinus meningioma. Primary objective is to compare long-term cognitive and/or functional (visual, hearing, neurological and/or endocrinological) deterioration between patients treated by fractionated proton-therapy (PRT) or photon radiotherapy (XRT), 5 years after the end of irradiation. The primary endpoint is based on the individual neurocognitive test scores (grouped into five cognitive domains: attention, executive functioning, verbal memory, working memory, information processing speed) and on visual, hearing, endocrinological and neurological evaluations, five years after radiotherapy. Eligible patients with low-grade cavernous sinus meningioma will be 1:1 randomised, with stratification on age, sex, MoCA score. Overall, the inclusion of 160 patients is planned (80 in each arm). To be considered as positive, asumming that 47% of patients will not develop long-term cognitive disabilities deficits after XRT radiotherapy, thus at least 70% of the patients treated with PRT should not develop functional impairment. First inclusions started on September 2023 (NCT05895344 ).Trial registration The study was registered on clinicaltrials.gov on June 8, 2023 with the following number: NCT05895344

• Publisher: CCSD,BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Biomedical and Life Sciences / Biomedicine / Brain cancer / Cancer Research / Care and treatment / Cavernous Sinus - pathology / Clinical outcomes / Cognition / Cognitive ability / Complications / Dosimetry / Executive function / Female / Glioma / Health Promotion and Disease Prevention / Humans / Information processing / Irradiation / Language / Life Sciences / Life span / Male / Medicine/Public Health / Memory / Meningeal Neoplasms - radiotherapy / Meningioma / Meningioma - radiotherapy / Middle Aged / Neurological disorders / Oncology / Patients / Pediatrics / Pituitary gland / Prospective Studies / Proton beam radiotherapy / Proton Therapy - adverse effects / Proton Therapy - methods / Protontherapy / Quality of life / Radiation therapy / Randomized Controlled Trials as Topic / Sinuses / Skull base / Study Protocol / Surgical Oncology / Testing / Toxicity / Tumors
• ISBN: 9780013892793, 0013892797