RecruitingPhase 2Phase 3NCT03534050

Neuropsychological and Oncological Outcomes in Grade 2 or 3 Glioma Patients Undergoing Postoperative Modern Radiotherapy

Neuropsychological and Oncological Outcomes in Grade 2 or 3 Glioma Patients Undergoing Postoperative Modern Radiotherapy - A Prospective Follow-up Study


Sponsor

Chang Gung Memorial Hospital

Enrollment

80 participants

Start Date

Aug 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 YearsMax Age: 84 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying how modern radiation therapy affects memory, thinking, and quality of life in patients with lower-grade brain tumors (grade 2 or 3 gliomas), to better understand and minimize cognitive side effects of treatment. **You may be eligible if...** - You have been diagnosed with a grade 2 or 3 brain glioma (a lower-grade brain tumor) - You have had surgery (either a full or partial removal or a biopsy) to confirm the diagnosis - You are recommended for radiation therapy because of high-risk features such as your age over 40 at surgery or incomplete tumor removal - You are in reasonably good health (ECOG score of 0–2 or Karnofsky score of at least 70%) **You may NOT be eligible if...** - Your tumor is the most aggressive grade (grade IV glioblastoma) or the most benign grade (grade I pilocytic astrocytoma) - Imaging suggests your tumor is the diffuse type called gliomatosis cerebri - You have previously received radiation to the brain for any reason Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONpostoperative adjuvant RT

Locations(1)

Chang Gung Memorial Hospital

Taoyuan, Taiwan

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NCT03534050


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