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

Sep 21, 2026

Uploaded by Theodora

Proton therapy (PRT) is assessed against conventional photon radiotherapy (XRT) for cavernous sinus benign meningioma using a randomized phase III study protocol. The rationale is PRT’s ballistic depth-dose profile, which is expected to spare healthy tissues and reduce long-term neurocognitive and functional toxicity. The trial targets five-year post-irradiation deterioration in cognitive, visual, hearing, neurological and endocrinological outcomes, addressing the current lack of prospective evidence in this patient population.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages9

Reading Time23 min

AccessFree to download

Background

Methods

Trial design and objectives

Eligibility and endpoints

Trial registration

Keywords

Background (disease and rationale)

Lesueur et al. BMC Cancer (2024) 24:1594 BMC Cancer [https://doi.org/10.1186/s12885-024-13353-9](https://doi.org/10.1186/s12885-024-13353-9) STUDY PROTOCOL Open Access Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COGPROTON-01) Paul Lesueur 1,2,3*, Benedicte Clarisse4, Justine Lequesne4, Idl ir Licaj4,5, Loic Feuvret6, Dinu Stefan 1, Damien Ricard7, Georges Noel8, Jacques Balosso 1, Marie Lange4, Aurel ie Capel4, Isabelle Durand-Zaleski9, Marie Castera4, Berenice Legrand4, Nicolas Goliot 1, Camille Hedou4, Jean Michel Grellard4 and Samuel Valable2 Abstract 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 formeningioma 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 *Correspondence: Paul Lesueur [paul.lesueur89@gmail.com](paul.lesueur89@gmail.com) Full list of author information is available at the end of the article © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creati](http://creati)[vecommons.org/l](vecommons.org/l)icenses/by-nc-nd/4.0/. Lesueur et al. BMC Cancer (2024) 24:1594 Pa

FAQs

Why is proton therapy expected to be beneficial compared with photon radiotherapy for meningioma patients?

Proton therapy offers a ballistic depth-dose distribution that reduces radiation exposure to healthy tissues versus photon therapy, with the goal of lowering long-term neurocognitive and functional toxicity.

What is the primary objective and timing of COG-PROTON-01?

The study aims to compare long-term cognitive and/or functional deterioration between fractionated proton therapy and photon radiotherapy, assessed five years after the end of irradiation.

How are the primary endpoints measured in the trial?

Primary endpoints are based on individual neurocognitive test scores grouped into five cognitive domains, along with visual, hearing, endocrinological and neurological evaluations five years after radiotherapy.

Sep 21, 2026

Uploaded by Theodora