Behaviors and Mental Disorders

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Cognitive Dysfunction

Meningioma

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

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)

Proton-therapy

Photon radiotherapy

Paul LESUEUR, MD

Jean-Michel GRELLARD

Damien RICARD, PhD

Pierre-Yves BONDIAU, PhD

Emmanuel JOUGLAR, MD

Georges NOEL, PhD

Justine ATTAL, MD

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

Multicenter prospective comparative phase 3 randomized 1:1 trial

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

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

Neurocognitive deterioration defined as the occurrence of cognitive impairment (a total of 5 impaired z-scores (17 z-scores for 6 different tests)

National Cancer Institute, France

Centre Francois Baclesse

Gland and Hormone Related Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Patients with:

- meningioma of the cavernous sinus for which radiotherapy is planned

Or

- a pituitary adenoma for which radiotherapy is planned

Patients will answer several questionnaires one and two years after irradiation treatment end.

Evaluation of autobiographical memory

Olivier BRANCHARD

Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes.

However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus.

The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.

Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for who radiotherapy is indicated will be recruited.

Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes. However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus, as specified in Nadel and Moscovitch model, the Multiple Trace Theory.

Autobiographical memory impairment issue is fundamental for identity construction. Prevent those impairments is important to quality of life improvement after such treatments.

The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.

A pilot study was conducted with 10 patients affected by left cavernous sinus meningioma divided in two groups: the first one with untreated patients and the second one with patients who received cavernous sinus irradiation between 2 and 5 years before pilot study. This study indicated autobiographical memory deterioration in two groups and a worsening in treated group. Study limits did not allow us to draw conclusions. That is why, sample size will be extended and patients with cavernous sinus meningioma or pituitary adenoma will be recruited because of proximity between cavernous sinus, pituitary gland and hippocampus. Investigators wish to recruit 30 patients with cavernous sinus and meningioma.

Investigators hope for confirm our results from pilot study.

Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory

Patient could request investigator an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004).

University Hospital, Bordeaux

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT05895344	Cavernous Sinus... Proton-therapy Photon Radiothe... Cognitive Impai...	Proton-therapy Photon radiothe...	18 Years - 60 Years	Centre Francois Baclesse
Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory	NCT02750371	Cavernous Sinus... Pituitary Adeno...	Evaluation of a...	35 Years - 65 Years	University Hospital, Bordeaux
Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory	NCT02750371	Cavernous Sinus... Pituitary Adeno...	Evaluation of a...	35 Years - 65 Years	University Hospital, Bordeaux
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	NCT05895344	Cavernous Sinus... Proton-therapy Photon Radiothe... Cognitive Impai...	Proton-therapy Photon radiothe...	18 Years - 60 Years	Centre Francois Baclesse

Spots Global Cancer Trial Database for cavernous sinus meningioma