Brain MetastasesNCT03626818
The Impact of Neurocognitive Function in Patients With Multiple Brain Metastases Receiving Whole Brain Radiation Therapy
An observational study of Brain Metastases, run by Guangdong Association of Clinical Trials at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- Aug 2018to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple brain metastases will be referred through the department of Neurosurgery,Medical Oncology and Radiation-oncology at Guangdong General Hospital.
Who may be able to join
- Pathologically proven solid tumor malignancy.
- 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).
- Males or females aged ≥18 years, < 75 years.
- had an Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 to 2.
- A life expectancy of at least 3 months.
- Adequate organ function according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0
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- Subjects did not receive other treatments such as cytotoxic drugs, radiotherapy (non-brain metastases) or surgery within 2 weeks.
- Patients must have ability and general health that permits completion of the study requirements and required follow up.
- Patients must be willing to complete NCF and QOL assessments at pre-specified time points outlined in the protocol.
- Signed written informed consent
Who cannot join
- Prior radiation therapy to the brain.
- Radiologically or pathologically confirmed metastases in the spinal cord or meninges.
- Taking sedatives and hypnotics, phenytoin, carbamazepine, rifampin, and barbiturate.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, hepatic, renal, or metabolic disease).
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong General Hospital & Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080
Yi Pan, Dr.
Yi Pan, Dr.
About this study
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.
Read the 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) .
- Conditions
- Brain Metastases
- Keywords
- WBRT, NCT
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed recall deterioration rate(HVLT-R)
Measured: At 6 month
Secondary outcomes (6)
Change in delayed recall(HVLT-R)
Measured: At 6th week, 3rd, 9th, 12th month
Change in recall(HVLT-R)
Measured: At 6th week, 3rd, 6th, 9th, 12th month
Change score(MMSE)
Measured: At 6th week, 3rd, 6th, 9th, 12th month
Change score(QLQBN20)
Measured: At 6th week, 3rd, 6th, 9th, 12th month
Intracranial progression-free survival for patients with different Graded Prognostic Assessment scores
Measured: At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until Performance Status> 2 or intracranial tumor progression
Overall survival for patients with different GPA scores
Measured: At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until PS> 2 or intracranial tumor progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Pan, Dr., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626818
- Sponsor's protocol ID
- CTONG1703
- Status last verified
- Feb 2018
- First submitted
- 8 Aug 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Neurocognitive Function in Patients With Multiple Brain Metastases Receiving Whole Brain Radiation Therapy
- ClinicalTrials.gov ID
- NCT03626818
- Acronym / sponsor ID
- CTONG1703
- Conditions
- Brain Metastases
- Keywords
- WBRT, NCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple brain metastases will be referred through the department of Neurosurgery,Medical Oncology and Radiation-oncology at Guangdong General Hospital.
Key inclusion criteria (10 listed)
- Pathologically proven solid tumor malignancy.
- 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).
- Males or females aged ≥18 years, < 75 years.
- had an Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 to 2.
- A life expectancy of at least 3 months.
Key exclusion criteria (7 listed)
- Prior radiation therapy to the brain.
- Radiologically or pathologically confirmed metastases in the spinal cord or meninges.
- Taking sedatives and hypnotics, phenytoin, carbamazepine, rifampin, and barbiturate.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, hepatic, renal, or metabolic disease).
- Subjects suffered from dementia, mental illness and other serious cognitive dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delayed recall deterioration rate(HVLT-R)
Time frame: At 6 month
6 secondary outcomes
Change in delayed recall(HVLT-R)
Time frame: At 6th week, 3rd, 9th, 12th month
Change in recall(HVLT-R)
Time frame: At 6th week, 3rd, 6th, 9th, 12th month
Change score(MMSE)
Time frame: At 6th week, 3rd, 6th, 9th, 12th month
Change score(QLQBN20)
Time frame: At 6th week, 3rd, 6th, 9th, 12th month
Intracranial progression-free survival for patients with different Graded Prognostic Assessment scores
Time frame: At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until Performance Status> 2 or intracranial tumor progression
Overall survival for patients with different GPA scores
Time frame: At baseline,6th week, 3rd, 6th, 9th, 12th month, and every 6 months until PS> 2 or intracranial tumor progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Pan, Dr. principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases, run by Guangdong Association of Clinical Trials at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Pan, Dr. (0086-13719188887, panyiff01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed recall deterioration rate(HVLT-R) (time frame: At 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.