Memory Preservation of Hippocampal Avoidance Whole Brain Radiotherapy
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|ClinicalTrials.gov Identifier: NCT03247127|
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases Neurocognitive Function||Radiation: Hippocampal avoidance whole brain radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Hippocampal avoidance -whole brain radiotherapy(HA-WBRT), which delivers radiation to whole brain and moreover, to reduce mean dose to hippocampal neural stem-cell compartment to minimize the neurocognitive function impairment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Memory Preservation Study of Whole Brain Radiotherapy With Hippocampal Avoidance for Patients With Brain Metastases|
|Actual Study Start Date :||March 27, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Patients with brain metastases outside a 5-mm margin around either hippocampus and are eligible to this study will receive hippocampal avoidance whole brain radiotherapy 30 gray (Gy) in 10 fractions. The primary endpoint is Wechsler Memory Scale (Chinese) and cognitive abilities screening instrument (CASI) at 4 months.
Radiation: Hippocampal avoidance whole brain radiotherapy
Planning target volume(PTV) for whole brain is Whole brain parenchyma plus2mm margin excluding metastases and HA region, 30Gy in 10 fractions will be delivered to PTVwhole brain. Bilateral Hippocampus will be contoured according to Radiation Therapy Oncology Group 0933 and hippocampal avoidance region is Hippocampi + 5mm margin. According to Radiation Therapy Oncology Group 0933 trial, dose to 100% of the hippocampus could not exceed 9 Gy, and maximal hippocampal dose could not exceed 16 Gy; dose to 100% of the hippocampus exceeding 10 Gy
- Changes of Memory immediate recall and delayed recall [ Time Frame: From baseline to 4 months after RT complete, tests are performed at baseline before radiotherapy begins, 2 months after radiotherapy complete and 4 months after radiotherapy complete. ]The memory battery is using Wechsler Memory Scale (Chinese), including Logical Memory I & II, Word Lists Ⅰ & II, Faces Ⅰ and spatial span.
- Changes of general cognitive function [ Time Frame: From baseline to 4 months after RT complete, tests are performed at baseline before radiotherapy begins, 2 months after radiotherapy complete and 4 months after radiotherapy complete. ]General cognitive function are tested using cognitive abilities screening instrument, CASI for screening and to test cognitive function as a whole.
- Changes of Quality of life [ Time Frame: From baseline to 4 months after RT complete, the participants are requested to fill in the questionnaire of quality of life at baseline before radiotherapy begins, and 2 months after radiotherapy complete and 4 months after radiotherapy complete. ]Quality of life are assessed using The Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247127
|Contact: Pen-Tzu Fang, MD||886-7-3121101 ext firstname.lastname@example.org|
|Kaohsiung, Taiwan, 80660|
|Contact: Fang Pen-Tzu, MD 886-7-3121101 ext 7158 email@example.com|
|Principal Investigator:||Pen-Tzu Fang, MD||Department of Radiation Oncology, Kaohsiung Medical University Hospital|