Main Menu
Main Menu
For newly-diagnosed patients with brain metastasis, whole brain radiation therapy (WBRT) probably remains a common palliative management even for those with oligometastatic brain disease. However, WBRT-related late sequelae, particularly a decline in neurocognitive functions (NCFs), are a major concern. More importantly, in patients with limited brain metastases and a fair/good performance status, sparing the radiosensitive and vulnerable structures which are responsible for essential NCFs during the WBRT course is one of the reasonable strategies to postpone and prevent the development of WBRT-induced neurocognitive impairments. Actually, radiation-related neurocognitive dysfunction is usually characterized as a decline involving learning and memory, in which the extremely radiosensitive hippocampus indeed plays a critical role. In addition to the neurocognitive preservation by virtue of sparing the radiosensitive structures like the hippocampus, durable intracranial tumor control critically depends on an escalated radiotherapeutic dose level which is adequate enough to eradicate gross metastatic brain lesions. Therefore, in order to achieve both hippocampal sparing and simultaneous integrated boost(s) to gross metastatic foci, a specialized WBRT technique, hippocampal avoidance during WBRT plus simultaneous integrated boost (SIB) will be adopted in this prospective study. Moreover, the dose-effect relationship would be analyzed in order to explore the correlation between the equivalent uniform dose (EUD) irradiating the hippocampus and the neurocognitive change/decline after the above WBRT course measured by objective neurocognitive test tools. Newly-diagnosed cancer patients harboring 1-3 gross metastatic lesions but still in fair/good performance statuses are potentially eligible. All recruited patients should receive baseline functional brain MRI examination and baseline neurobehavioral assessment. Treatment planning will be designed via the technique of volumetric-modulated arc therapy (VMAT) to achieve both hippocampal avoidance and simultaneous integrated boost(s) to gross metastatic lesions. Except for the above regions for which conformal avoidance or SIB is attempted, the prescribed dose to the remaining brain parenchyma will be consistently 3000 cGy in 12 fractions. Accordingly, a battery of neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal and 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 the WBRT course. This prospective cohort study aims to examine thoroughly the impact of a specialized WBRT technique, integrating both simultaneous integrated boost(s) delivered to gross metastatic foci and conformal hippocampal avoidance, on the status of NCF change/decline in patients with oligometastatic brain disease. It is anticipated that intracranial local control will be more sustainable and durable resulting from the escalated focal dose of SIBs. Ultimately, we also expect the dose-effect relationship will be clearly demonstrated after investigating the correlation between the hippocampal dosimetry and the status of NCF change/decline after receiving HA-WBRT plus SIB.
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 20 Years - 84 Years |
| Gender | All |
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03223675 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Chang Gung Memorial Hospital |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | Taiwan |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Brain Metastasis, Brain Metastases |
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
