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New study aims to reduce brain fog after radiation for skull tumors

NCT ID NCT05895344

Knowledge-focused Sponsor: Centre Francois Baclesse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at two types of radiation therapy for a slow-growing brain tumor near the cavernous sinus. Researchers want to see if proton therapy causes less long-term harm to thinking and memory than standard photon radiation. About 160 adults aged 18 to 70 will be followed for years after treatment. The goal is to find out which method better protects brain function over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Aug 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cavernous sinus meningioma Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cavernous sinus meningioma Cognitive impairment Photon radiotherapy Proton therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Grenoble-Alpes

    NOT_YET_RECRUITING

    Grenoble, France

  • Centre Antoine Lacassagne

    NOT_YET_RECRUITING

    Nice, France

  • Centre Francois Baclesse

    RECRUITING

    Caen, 14000, France

  • Centre Guillaume le Conquerant

    NOT_YET_RECRUITING

    Le Havre, France

  • Centre Léon Bérard

    NOT_YET_RECRUITING

    Lyon, France

  • Centre Paul Strauss

    NOT_YET_RECRUITING

    Strasbourg, France

  • Gustave Rousy

    NOT_YET_RECRUITING

    Villejuif, France

  • Hopital d'Instruction des Armées PERCY

    NOT_YET_RECRUITING

    Clamart, France

  • Hospices civils de Lyon

    NOT_YET_RECRUITING

    Lyon, France

  • Hôpital Pitié Salpétrière

    NOT_YET_RECRUITING

    Paris, France

  • IUCT

    RECRUITING

    Toulouse, France

  • Institut Curie

    RECRUITING

    Paris, France

  • Institut Curie

    NOT_YET_RECRUITING

    Saint-Cloud, France

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