Clinical trial NCT03626818: The Impact of Neurocognitive Function in Patients With Multiple Brain Metastases Receiving Whole Brain Radiation Therapy
Official title: The Impact of Neurocognitive Function in Patients With Multiple Brain Metastases Receiving Whole Brain Radiation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Metastases
Keywords: WBRT
NCT
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multiple brain metastases will be referred through the department of Neurosurgery,Medical Oncology and Radiation-oncology at Guangdong General Hospital.

Brief summary: Brain metastases (BM), occurring in 10-30% of adult cancer patients, are an important cause of morbidity and mortality.The prognosis of patients with BM is generally poor, with a median survival time of 2-6 months. Whole-brain radiation therapy (WBRT) has been advocated as the primary treatment for metastatic brain cancer. WBRT injures small cerebral vasculature and neuropil,effects linked to imaging-defined white matter changes. However, information on the neurocognitive function(NCF) impact of WBRT in BM patients is also limited.This study aims to explore and evaluate the impact of NCF in patients with multiple brain metastases receiving WBRT.

Detailed description: Brain metastases (BM), occurring in 10-30% of adult cancer patients, are an important cause of morbidity and mortality.The prognosis of patients with BM is generally poor, with a median survival time of 2-6 months. Whole-brain radiation therapy (WBRT) has been advocated as the primary treatment for metastatic brain cancer. WBRT injures small cerebral vasculature and neuropil,effects linked to imaging-defined white matter changes. However, information on the neurocognitive function(NCF) impact of WBRT in BM patients is also limited.This study aims to explore and evaluate the impact of NCF in patients with multiple brain metastases receiving WBRT.All patients were assessed at each visit for NCF according to the Hopkins Verbal Learning Test-Revised(HVLT-R),Mini-Mental Status Examination(MMSE) and Quality Of Life measurements(QOL,Questionnaire-QLQC30) .

Eligibility criteria: Inclusion Criteria:

1. Pathologically proven solid tumor malignancy.
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:

1. Prior radiation therapy to the brain.
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

Primary outcomes:
measure: Delayed recall deterioration rate(HVLT-R)
timeFrame: At 6 month
Secondary outcomes:
measure: Change in delayed recall(HVLT-R)
timeFrame: At 6th week, 3rd, 9th, 12th month
measure: Change in recall(HVLT-R)
timeFrame: At 6th week, 3rd, 6th, 9th, 12th month
measure: Change score(MMSE)
timeFrame: At 6th week, 3rd, 6th, 9th, 12th month
measure: Change score(QLQBN20)
timeFrame: At 6th week, 3rd, 6th, 9th, 12th month
measure: Intracranial progression-free survival for patients with different Graded Prognostic Assessment scores
timeFrame: At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until Performance Status> 2 or intracranial tumor progression
measure: Overall survival for patients with different GPA scores
timeFrame: At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until PS> 2 or intracranial tumor progression
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital & Guangdong Academy of Medical Sciences
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yi Pan, Dr.
role: PRINCIPAL_INVESTIGATOR
References: