The Impact of Neurocognitive Function in Patients With Multiple Brain Metastases Receiving Whole Brain Radiation Therapy

Brain Metastases Clinical Trial

Official title:

The Impact of Neurocognitive Function in Patients With Multiple Brain Metastases Receiving Whole Brain Radiation Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03626818
• Other study ID #: CTONG1703
• Status: Not yet recruiting
• Start date: August 2018
• Est. completion date: June 2021

Study information

• Verified date: February 2018
• Source: Guangdong Association of Clinical Trials
• Contact: Yi Pan, Dr.
• Phone: 0086-13719188887
• Email: panyiff01[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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) .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: June 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
China	Guangdong General Hospital & Guangdong Academy of Medical Sciences	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed recall deterioration rate(HVLT-R)		At 6 month
Secondary	Change in delayed recall(HVLT-R)		At 6th week, 3rd, 9th, 12th month
Secondary	Change in recall(HVLT-R)		At 6th week, 3rd, 6th, 9th, 12th month
Secondary	Change score(MMSE)		At 6th week, 3rd, 6th, 9th, 12th month
Secondary	Change score(QLQBN20)		At 6th week, 3rd, 6th, 9th, 12th month
Secondary	Intracranial progression-free survival for patients with different Graded Prognostic Assessment scores		At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until Performance Status> 2 or intracranial tumor progression
Secondary	Overall survival for patients with different GPA scores		At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until PS> 2 or intracranial tumor progression