跳至主要内容
临床试验/NCT05895344
NCT05895344招募中不适用

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

Centre Francois Baclesse20 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
20
主要终点
functional deterioration evaluated by individual neurocognitive test scores

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

photon radiotherapy

Active Comparator

Intensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions)

干预措施: Photon radiotherapy (Radiation)

proton-therapy

Experimental

Proton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions)

干预措施: Proton-therapy (Radiation)

结局指标

主要结局

functional deterioration evaluated by individual neurocognitive test scores

时间窗: 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)

次要结局

未报告次要终点

研究者

发起方
Centre Francois Baclesse
申办方类型
Other
责任方
Sponsor

研究点 (20)

Loading locations...

相似试验