Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COG-PROTON-01)
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 indi...
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2024-12-01
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| Online Access: | https://doi.org/10.1186/s12885-024-13353-9 |
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| author | Paul Lesueur Benedicte Clarisse Justine Lequesne Idlir Licaj Loic Feuvret Dinu Stefan Damien Ricard Georges Noel Jacques Balosso Marie Lange Aurelie Capel Isabelle Durand-Zaleski Marie Castera Berenice Legrand Nicolas Goliot Camille Hedou Jean Michel Grellard Samuel Valable |
| author_facet | Paul Lesueur Benedicte Clarisse Justine Lequesne Idlir Licaj Loic Feuvret Dinu Stefan Damien Ricard Georges Noel Jacques Balosso Marie Lange Aurelie Capel Isabelle Durand-Zaleski Marie Castera Berenice Legrand Nicolas Goliot Camille Hedou Jean Michel Grellard Samuel Valable |
| author_sort | Paul Lesueur |
| collection | DOAJ |
| description | 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 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: NCT 05895344. |
| format | Article |
| id | doaj-art-5711174e262746d995baaa456c80ae8f |
| institution | Kabale University |
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| language | English |
| publishDate | 2024-12-01 |
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| series | BMC Cancer |
| spelling | doaj-art-5711174e262746d995baaa456c80ae8f2025-01-05T12:33:15ZengBMCBMC Cancer1471-24072024-12-012411910.1186/s12885-024-13353-9Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COG-PROTON-01)Paul Lesueur0Benedicte Clarisse1Justine Lequesne2Idlir Licaj3Loic Feuvret4Dinu Stefan5Damien Ricard6Georges Noel7Jacques Balosso8Marie Lange9Aurelie Capel10Isabelle Durand-Zaleski11Marie Castera12Berenice Legrand13Nicolas Goliot14Camille Hedou15Jean Michel Grellard16Samuel Valable17Department of Radiation Oncology, François Baclesse CenterDepartment of Clinical Research, François Baclesse CenterDepartment of Clinical Research, François Baclesse CenterDepartment of Clinical Research, François Baclesse CenterDepartment of Radiation Oncology, Hospices civils de LyonDepartment of Radiation Oncology, François Baclesse CenterDepartment of neurology, Hôpital d’Instruction des Armées Percy, Service de Santé des ArméesDepartment of Radiation Oncology, ICANS (Cancerology Institute of Strasbourg-Europe)Department of Radiation Oncology, François Baclesse CenterDepartment of Clinical Research, François Baclesse CenterDepartment of Clinical Research, François Baclesse CenterUniversité de Paris, CRESS, INSERM, INRA, URCEco, AP-HP, Hôpital de l’Hôtel DieuDepartment of Clinical Research, François Baclesse CenterDepartment of Clinical Research, François Baclesse CenterDepartment of Radiation Oncology, François Baclesse CenterDepartment of Clinical Research, François Baclesse CenterDepartment of Clinical Research, François Baclesse CenterISTCT UMR 6030-CNRS, Université de Caen-NormandieAbstract 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: NCT 05895344.https://doi.org/10.1186/s12885-024-13353-9MeningiomaSkull baseProtontherapyCognitionIrradiation |
| spellingShingle | Paul Lesueur Benedicte Clarisse Justine Lequesne Idlir Licaj Loic Feuvret Dinu Stefan Damien Ricard Georges Noel Jacques Balosso Marie Lange Aurelie Capel Isabelle Durand-Zaleski Marie Castera Berenice Legrand Nicolas Goliot Camille Hedou Jean Michel Grellard Samuel Valable Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COG-PROTON-01) BMC Cancer Meningioma Skull base Protontherapy Cognition Irradiation |
| title | Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COG-PROTON-01) |
| title_full | Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COG-PROTON-01) |
| title_fullStr | Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COG-PROTON-01) |
| title_full_unstemmed | Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COG-PROTON-01) |
| title_short | Proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma, a randomized controlled phase III study protocol (COG-PROTON-01) |
| title_sort | proton therapy versus conventional radiotherapy for the treatment of cavernous sinus benign meningioma a randomized controlled phase iii study protocol cog proton 01 |
| topic | Meningioma Skull base Protontherapy Cognition Irradiation |
| url | https://doi.org/10.1186/s12885-024-13353-9 |
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