Comparing the long-term effects of proton therapy and photon radiotherapy on cognitive function in patients with cavernous sinus meningioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Francois Baclesse
  Caen, France Recruiting
• Institut Curie
  Paris, France Recruiting
• Iuct
  Toulouse, 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

Study contacts

• Study coordinator: Jeanne RIVERAIN, MD
• Email: j.riverain@baclesse.unicancer.fr
• Phone: +33 2 31 45 50 50

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.