Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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…). 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre Francois Baclesse
RECRUITING
Caen
Hopital d'Instruction des Armées PERCY
NOT_YET_RECRUITING
Clamart
CHU Grenoble-Alpes
NOT_YET_RECRUITING
Grenoble
Centre Guillaume le Conquerant
NOT_YET_RECRUITING
Le Havre
Centre Léon Bérard
NOT_YET_RECRUITING
Lyon
Hospices civils de Lyon
NOT_YET_RECRUITING
Lyon
Centre Antoine Lacassagne
NOT_YET_RECRUITING
Nice
Hôpital Pitié Salpétrière
NOT_YET_RECRUITING
Paris
Institut Curie
RECRUITING
Paris
Institut Curie
NOT_YET_RECRUITING
Saint-cloud
Centre Paul Strauss
NOT_YET_RECRUITING
Strasbourg
IUCT
RECRUITING
Toulouse
Gustave Rousy
NOT_YET_RECRUITING
Villejuif
Contact Information
Primary
Jeanne RIVERAIN, MD
j.riverain@baclesse.unicancer.fr
+33 2 31 45 50 50
Backup
Jean-Michel GRELLARD
jm.grellard@baclesse.unicancer.fr
+33 2 31 45 50 50
Time Frame
Start Date: 2024-02-26
Estimated Completion Date: 2032-08
Participants
Target number of participants: 160
Treatments
Experimental: proton-therapy
Proton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions)
Active_comparator: photon radiotherapy
Intensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions)
Related Therapeutic Areas
Sponsors
Collaborators: National Cancer Institute, France
Leads: Centre Francois Baclesse

This content was sourced from clinicaltrials.gov