Cavernous Sinus MeningiomaCOG-PROTON-01NCT05895344
Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma: An Open-label Randomized 1:1 Phase III Study
A study testing Proton-therapy and Photon radiotherapy in people with Cavernous Sinus Meningioma and Proton-therapy, run by Centre Francois Baclesse at 13 sites in France.
Trial summary
Cavernous sinus meningiomas are close to optic nerve, pituitary gland, cranial nerve, and hippocampi. The doses delivered to these structures are crucial and radiotherapy of cavernous sinus meningiomas exposes patients to late secondary effects (pituitary deficit, nerve palsy, cognitive impairment…). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cavernous Sinus Meningioma, Proton-therapy, Photon Radiotherapy
- What is being tested?
- Proton-therapy and Photon radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 13 sitesFrance
- Study dates
- 26 Feb 2024to Aug 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Recruiting
Centre Francois Baclesse
Caen, 14000
Jeanne RIVERAIN, MD, 33 2 31 45 50 50, j.riverain@baclesse.unicancer.fr
Jeanne RIVERAIN, MD
- Not yet recruiting
Hopital d'Instruction des Armées PERCY
Clamart
Damien RICARD, PhD
Damien RICARD, PhD
- Not yet recruiting
CHU Grenoble-Alpes
Grenoble
Alexandre, MD
Alexandre LEBOUCHER, MD
- Not yet recruiting
Centre Guillaume le Conquerant
Le Havre
Paul LESUEUR, MD, 33 2 35 13 66 13, p.lesueur@cglc.fr
Paul LESUEUR, MD
- Not yet recruiting
Centre Léon Bérard
Lyon
Marie-Pierre SUNYACH, PhD
- Not yet recruiting
Hospices civils de Lyon
Lyon
Loic FEUVRET, MD
- Not yet recruiting
Centre Antoine Lacassagne
Nice
Pierre-Yves BONDIAU, PhD
Pierre-Yves BONDIAU, PhD
- Not yet recruiting
Hôpital Pitié Salpétrière
Paris
Julian JACOB, MD
Julian JACOB, MD
- Recruiting
Institut Curie
Paris
Emmanuel JOUGLAR, MD
Emmanuel JOUGLAR, MD
- Not yet recruiting
Institut Curie
Saint-Cloud
Maxime LOO, MD
Maxime LOO, MD
- Not yet recruiting
Centre Paul Strauss
Strasbourg
Georges NOEL, PhD, 33 3 68 76 73 76, g.noel@icans.eu
Georges NOEL, PhD
- Recruiting
IUCT
Toulouse
Justine ATTAL, MD
Justine ATTAL, MD
- Not yet recruiting
Gustave Rousy
Villejuif
Noura SELLAMI, MD, 33142115542, noura.sellami@gustaveroussy.fr
Noura SELLAMI, MD
About this study
Official title: Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma
Cavernous sinus meningiomas are close to optic nerve, pituitary gland, cranial nerve, and hippocampi.
The doses delivered to these structures are crucial and radiotherapy of cavernous sinus meningiomas exposes patients to late secondary effects (pituitary deficit, nerve palsy, cognitive impairment…). In 2012, Gondi reported that a dose given to 40% of the bilateral hippocampi greater than 7.3 Gy is associated with long-term impairment in list-learning delayed recall after FSRT for benign or low-grade adult brain tumors.
Read more
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.
In this context, a randomized prospective study, evaluating long-term toxicity of these two irradiation modalities (Proton Therapy (PRT) and photon radiotherapy (XRT)) seems crucial to further assess proton-therapy indication for these patients.
Although literature reports excellent outcomes for intracranial meningioma patients treated by proton-therapy, none of the eight retrospective studies found in the literature used an accurate and full evaluation of long-term toxicity
- Being tested
- Proton-therapy, Photon radiotherapy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton-therapyRadiation
Proton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions)
Photon radiotherapyRadiation
Intensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions)
| Study group | Role | What they receive |
|---|---|---|
| proton-therapy | Experimental | Proton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions) Receives: Radiation: Proton-therapy |
| photon radiotherapy | Active comparator | Intensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions) Receives: Radiation: Photon radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional deterioration evaluated by individual neurocognitive test scores
Neurocognitive deterioration defined as the occurrence of cognitive impairment (a total of 5 impaired z-scores (17 z-scores for 6 different tests)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start26 Feb 2024
- Primary completionFeb 2032 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cavernous Sinus MeningiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter prospective comparative phase 3 randomized 1:1 trial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895344
- Sponsor's protocol ID
- 2023-A00401-44
- Acronym
- COG-PROTON-01
- Status last verified
- Sep 2025
- First submitted
- 31 May 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lesueur P, Clarisse B, Lequesne J, Licaj I, Feuvret L, Stefan D, Ricard D, Noel G, Balosso J, Lange M, Capel A, Durand-Zaleski I, Castera M, Legrand B, Goliot N, Hedou C, Grellard JM, Valable S. 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. 2024 Dec 30;24(1):1594. doi: 10.1186/s12885-024-13353-9.
PubMed 39736544
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma
- ClinicalTrials.gov ID
- NCT05895344
- Acronym / sponsor ID
- COG-PROTON-01 / 2023-A00401-44
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- Feb 2032 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cavernous sinus meningiomas are close to optic nerve, pituitary gland, cranial nerve, and hippocampi.
The doses delivered to these structures are crucial and radiotherapy of cavernous sinus meningiomas exposes patients to late secondary effects (pituitary deficit, nerve palsy, cognitive impairment…). In 2012, Gondi reported that a dose given to 40% of the bilateral hippocampi greater than 7.3 Gy is associated with long-term impairment in list-learning delayed recall after FSRT for benign or low-grade adult brain tumors.
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.
In this context, a randomized prospective study, evaluating long-term toxicity of these two irradiation modalities (Proton Therapy (PRT) and photon radiotherapy (XRT)) seems crucial to further assess proton-therapy indication for these patients.
Although literature reports excellent outcomes for intracranial meningioma patients treated by proton-therapy, none of the eight retrospective studies found in the literature used an accurate and full evaluation of long-term toxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter prospective comparative phase 3 randomized 1:1 trial
| Arm | Type | Receives |
|---|---|---|
| proton-therapy | Experimental | Radiation: Proton-therapyProton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions) |
| photon radiotherapy | Active comparator | Radiation: Photon radiotherapyIntensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton-therapyProton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions) | Radiation | proton-therapy |
| Photon radiotherapyIntensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions) | Radiation | photon radiotherapy |
Primary outcome
functional deterioration evaluated by individual neurocognitive test scores
Time frame: 5 years
Neurocognitive deterioration defined as the occurrence of cognitive impairment (a total of 5 impaired z-scores (17 z-scores for 6 different tests)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Derived from this study: PubMed 39736544Lesueur P, Clarisse B, Lequesne J, Licaj I, Feuvret L, Stefan D, Ricard D, Noel G, Balosso J, Lange M, Capel A, Durand-Zaleski I, Castera M, Legrand B, Goliot N, Hedou C, Grellard JM, Valable S. 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. 2024 Dec 30;24(1):1594. doi: 10.1186/s12885-024-13353-9.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton-therapy and Photon radiotherapy in people with Cavernous Sinus Meningioma and Proton-therapy, run by Centre Francois Baclesse at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanne RIVERAIN, MD (+33 2 31 45 50 50, j.riverain@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional deterioration evaluated by individual neurocognitive test scores (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05895344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.