Comparing the long-term effects of proton therapy and photon radiotherapy on cognitive function in patients with cavernous sinus meningioma
Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma
This study is testing whether proton therapy or photon radiotherapy is better at protecting brain function and improving quality of life for patients with cavernous sinus meningioma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Centre Francois Baclesse Academic / other |
| Locations | 13 sites (Caen and 12 other locations) |
| Trial ID | NCT05895344 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the long-term cognitive and functional impacts of proton therapy versus modern fractionated radiotherapy in patients diagnosed with cavernous sinus meningioma. The study will involve a randomized 1:1 allocation of participants to receive either treatment, focusing on the potential neurocognitive outcomes associated with each approach. Given the proximity of these tumors to critical brain structures, the trial seeks to determine which treatment minimizes cognitive impairment and improves overall patient quality of life. The study is particularly relevant as there is currently no published data on the neurocognitive effects of these modern irradiation techniques in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 with a histologically proven Grade I cavernous sinus meningioma larger than 3 centimeters.
Not a fit: Patients with known genetic mutations predisposing them to meningiomas or those with a performance status greater than 1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that minimize cognitive impairment in patients with cavernous sinus meningioma.
How similar studies have performed: While there is limited published data on the neurocognitive effects of proton therapy versus photon therapy in this specific context, the approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cavernous sinus meningioma for which clinical target volume is larger than 3 centimeters * Anterior skull base meningioma, invading by contiguity the cavernous sinus can be included * Histologic proven Grade I meningioma * Meningioma for which biopsy is not safely achievable and for which growing and imaging criteria are in favour of grade I meningioma can be included * Age \>18 years and ≤70 years * Indication of irradiation validated by a pluridisciplinary meeting * Adjuvant or exclusive irradiation is allowed. * Use of conventional fractionation: 1.8Gy (RBE)/fraction * Signed informed consent form * WHO Performance status equal to 0 or 1 * Patient affiliated to the French social health insurance * MoCA score ≥ cut-off of GRECOGVASC normative data (Roussel, 2016, cf annexe 1) * Patient whose neuropsychological abilities allow to follow the requirements of the protocol Exclusion Criteria: * Patient with mutation in a known predisposition gene (NF-2, SMARCE-1…) * Cerebrovascular pathology, presence of other tumors of the nervous system, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease and other dementias, organic psychosis (other than dementia), schizophrenia, and neurodegenerative disease * Radiosurgery, hypofractionated regimen * Other localization than cavernous sinus * Histologic proven Grade II or III meningioma * Patient with unadjusted antiepileptic drug * Contraindication to MRI * Patient with a history of brain irradiation * Patient with a history of cancer in the last five years (excluding skin baso-cellular carcinoma) * Pregnant/breastfeeding woman * Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study * Participation in a therapeutic trial for less than 30 days * Patient deprived of freedom or under guardianship
Where this trial is running
Caen and 12 other locations
- Centre Francois Baclesse — Caen, France (Recruiting)
- Hopital d'Instruction des Armées PERCY — Clamart, France (Not_yet_recruiting)
- CHU Grenoble-Alpes — Grenoble, France (Not_yet_recruiting)
- Centre Guillaume le Conquerant — Le Havre, France (Not_yet_recruiting)
- Centre Léon Bérard — Lyon, France (Not_yet_recruiting)
- Hospices civils de Lyon — Lyon, France (Not_yet_recruiting)
- Centre Antoine Lacassagne — Nice, France (Not_yet_recruiting)
- Hôpital Pitié Salpétrière — Paris, France (Not_yet_recruiting)
- Institut Curie — Paris, France (Recruiting)
- Institut Curie — Saint-Cloud, France (Not_yet_recruiting)
- Centre Paul Strauss — Strasbourg, France (Not_yet_recruiting)
- Iuct — Toulouse, France (Recruiting)
- Gustave Rousy — Villejuif, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Jeanne RIVERAIN, MD
- Email: j.riverain@baclesse.unicancer.fr
- Phone: +33 2 31 45 50 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.