Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
Location status: Recruiting
NCT Number: NCT03534050
Background: Infiltrative low grade gliomas (LGGs) are the most common primary central nervous system malignancies excluding the highest grade glioma, glioblastoma multiforme. Craniotomy with maximal safe tumor resection is endeavored to achieve longer survivals in LGG patients. Unfortunately, due to the infiltrative nature of gliomas and the frequent tumor location in eloquent areas, gross total resection is usually not applicable. According to National Comprehensive Cancer Network 2015 guidelines, postoperative adjuvant radiation therapy (RT) is recommended for most adult patients with low-grade infiltrative LGGs in order to enhance local control and prolong progression-free survival (PFS), except those who are no older than 40 years of age and in whom maximal safe resection is not feasible. However, brain irradiation-related neurocognitive function (NCF) sequelae are potentially and indeed a concern which should not be ignored. In terms of the time course of cranial irradiation-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline principally involve impairments of episodic memory, which has been significantly associated with functions of the hippocampus. This study thus aims to investigate the impact of partial brain irradiation with using contemporary radiotherapeutic techniques on neurocognitive performances, intracranial local control, and progression-free survival in patients with intracranial high-risk grade 2 or 3 gliomas.
Methods: Patients with intracranial high-risk low-grade or grade 3 gliomas will be enrolled to this study once postoperative adjuvant RT is recommended. All eligible and recruited patients should receive baseline functional brain MRI examination and baseline neurobehavioral assessment. Subsequently, partial cranial irradiation will be initiated within one month approximately after enrollment. Brain RT dose will be 5000 - 6000 cGy in 25 - 30 fraction during 5 - 7 weeks. Accordingly, a battery of neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal & non-verbal memory, working memory, and psychomotor speed), is used to evaluate neurobehavioral functions for our registered patients. The primary outcome measure is delayed recall, as determined by the change/decline in verbal memory or non-verbal memory from the baseline assessment to 4 months after the start of postoperative adjuvant RT.
Interested in participating?
Request Info20 year–84 year
All sexes
Interventional
Phase 2 / Phase 3
Taoyuan, 333, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 months after the start of postoperative adjuvant RT
Neurocognitive assessment: including memory, executive functions, and psychomotor speed. This neurocognitive outcome was delayed recall, as determined by the change/decline in verbal memory [Wechsler Memory Scale - 3rd edition (WMS III) - Word List score] from the baseline assessment to 4 months after the start of the course of postoperative adjuvant RT.
Time frame: 4 months after the start of postoperative adjuvant RT
Neurocognitive assessment: including memory, executive functions, and psychomotor speed. This neurocognitive outcome was delayed recall, as determined by the change/decline in non-verbal memory (WMS III- Visual Reproduction score) from the baseline assessment to 4 months after the start of the course of postoperative adjuvant RT.
Time frame: up to 24 months
Time frame: up to 24 months
Time frame: up to 24 months
The follow-up of neurocognitive assessment will be administered at 8 months, 12 months, 18 months and up to 24 months after the start of postoperative adjuvant RT.
Contact information is provided by the study sponsor or research team.
Chang Gung Memorial Hospital
Other
Neuropsychological and Oncological Outcomes in Grade 2 or 3 Glioma Patients Undergoing Postoperative Modern Radiotherapy - A Prospective Follow-up Study
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