The Impact of Neurocognitive Function in Patients With Multiple Brain Metastases Receiving Whole Brain Radiation Therapy
NCT ID: NCT03626818
Last Updated: 2018-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
125 participants
OBSERVATIONAL
2018-08-31
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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NCF group
The patients have received 10 daily fractions of 3 Gy WBRT. Following WBRT treatment, subjects were assessed at each visit for NCT according to the Hopkins Verbal Learning Test-Revised(HVLT-R),Mini-Mental Status Examination(MMSE) and Quality Of Life measurements(QOL,Questionnaire-QLQC30).These tests was administered by trained and certified nurses or clinical research associates at baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until PS\> 2 or intracranial tumor progression.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Brain MRI within 1 month of enrolment, at least three metastatic lesions in the brain (of which at least one had to be measurable according to Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1).
3. Males or females aged ≥18 years, \< 75 years.
4. had an Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 to 2.
5. A life expectancy of at least 3 months.
6. Adequate organ function according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0
7. Subjects did not receive other treatments such as cytotoxic drugs, radiotherapy (non-brain metastases) or surgery within 2 weeks.
8. Patients must have ability and general health that permits completion of the study requirements and required follow up.
9. Patients must be willing to complete NCF and QOL assessments at pre-specified time points outlined in the protocol.
10. Signed written informed consent
Exclusion Criteria
2. Radiologically or pathologically confirmed metastases in the spinal cord or meninges.
3. Taking sedatives and hypnotics, phenytoin, carbamazepine, rifampin, and barbiturate.
4. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, hepatic, renal, or metabolic disease).
5. Subjects suffered from dementia, mental illness and other serious cognitive dysfunction.
6.The patient's brain radiation dose needs to be increased. 7.Inability to comply with protocol or study procedures. 8.A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
9.Pregnant female. 10.Breast-feeding
18 Years
75 Years
ALL
No
Sponsors
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Guangdong Association of Clinical Trials
OTHER
Responsible Party
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Principal Investigators
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Yi Pan, Dr.
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
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Guangdong General Hospital & Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Yi Pan, Dr.
Role: primary
Other Identifiers
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CTONG1703
Identifier Type: -
Identifier Source: org_study_id
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