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

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ClinicalTrials.gov Identifier: NCT03534050
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Glioma of Brain Radiation: postoperative adjuvant RT Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neuropsychological and Oncological Outcomes in Grade 2 or 3 Glioma Patients Undergoing Postoperative Modern Radiotherapy - A Prospective Follow-up Study
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : July 31, 2026
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: postoperative adjuvant RT
In this prospective observational study, all potentially eligible patients are clinically indicated for receiving postoperative adjuvant RT. Namely, partial cranial irradiation will be initiated within one month approximately after enrollment. Prescription dose will be 5000 - 6000 cGy in 25 - 30 fraction during 5 - 7 weeks.
Radiation: postoperative adjuvant RT



Primary Outcome Measures :
  1. The primary endpoint is delayed recall, as determined by the change/decline in verbal memory (WMS III- Word List score) from the baseline assessment to 4 months after the start 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 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.

  2. The primary endpoint is 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 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.


Secondary Outcome Measures :
  1. Overall survival time, indicated by the time from the date of recruitment to the date of expiring. [ Time Frame: up to 24 months ]
  2. The time from the date of recruitment to that of intracranial progression/failure noted on brain MRI or CT. [ Time Frame: up to 24 months ]
  3. The delayed recall will follow up until 24 months after the start of postoperative adjuvant RT. [ 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.



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Ages Eligible for Study:   20 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with infiltrative low-grade gliomas who have received craniotomy plus tumor removal or at least biopsy with pathologic conformation; brain radiation therapy is recommended owning to some high-risk features including subtotal resection (STR) or age at craniotomy older than 40 years old
  • Good performance status no worse than Eastern Cooperative Group (ECOG) of 2 or a general status of Karnofsky Score (KPS) at least 70 %

Exclusion Criteria:

  • A pathological diagnosis confirmed to be WHO grade IV glioma (i.e., glioblastoma multiforme) or grade I disease (i.e., pilocystic astrocytoma)
  • Radiographic evidence of gliomatosis cerebri
  • Prior cranial irradiation for any reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534050


Contacts
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Contact: Shinn-Yn Lin, M.D. +886-33281200 ext 7172 rt3126@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Shinn-Yn Lin, M.D.    +886-33281200 ext 7172    rt3126@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03534050    
Other Study ID Numbers: 104-9201B
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
Glioma
Low-Grade Glioma (LGG)
Neurobehavioral Assessments
Neurocognitive Functions (NCF)
Radiation Therapy (RT)
Hippocampus
Progression-Free Survival (PFS)
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue