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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Proton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions)
Intensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions)
Centre Francois Baclesse
Caen, France
RECRUITINGHopital d'Instruction des Armées PERCY
Clamart, France
NOT_YET_RECRUITINGCHU Grenoble-Alpes
Grenoble, France
NOT_YET_RECRUITINGCentre Guillaume le Conquerant
Le Havre, France
NOT_YET_RECRUITINGCentre Léon Bérard
Lyon, France
NOT_YET_RECRUITINGHospices civils de Lyon
Lyon, France
NOT_YET_RECRUITINGCentre Antoine Lacassagne
Nice, France
NOT_YET_RECRUITINGHôpital Pitié Salpétrière
Paris, France
NOT_YET_RECRUITINGInstitut Curie
Paris, France
RECRUITINGInstitut Curie
Saint-Cloud, France
NOT_YET_RECRUITING...and 3 more locations
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)
Time frame: 5 years
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