Hippocampal-sparing Whole Brain Radiotherapy for Brain Metastases From Breast Cancer

Whole Brain Irradiation With Hippocampal Sparing for Brain Metastases From Breast Cancer: Neurocognitive Function and Prognosis Analysis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03002532

Enrollment

120

Registered

2016-12-23

Start date

2015-08-31

Completion date

2017-08-31

Last updated

2016-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Metastatic, Brain Metastases

Keywords

Breast cancer, Brain metastasis, Whole brain radiotherapy, Hippocampal avoidance, Neurocognitive function, intracranial failure

Brief summary

Based on evidence that radiation-induced damage to the hippocampus plays a considerable role in neurocognitive decline after cranial irradiation, hippocampal-sparing whole brain radiation therapy (HS-WBRT) has been proposed. This study will investigate the neurocognitive function and prognosis between HS-WBRT and conventional WBRT for the treatment of brain metastases from breast cancer.

Interventions

RADIATIONwhole brain radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Female patients with advanced breast cancer who is confirmed historically. * New developing brain metastases (BM) is confirmed by gadolinium contrast-enhanced magnetic resonance imaging (MRI), with or without clinical symptoms and pathology, and without a history of BM treatment. * At least 2 BM lesions with the diameter of the largest lesion \< 40 mm is eligible. And the distance from the border of a mass to the hippocampal margin should be more than 15 mm. * The Eastern Cooperative Oncology Group (ECOG) is from 0 to 2, and the expected life expectancy is ≥3 months.

Exclusion criteria

* Concurrent chemoradiation. * Patient who had received cranial irradiation previously. * Patient who are enrolled in other clinical trial at the same time. * Patient who has severe co-morbidity or infection.

Design outcomes

Primary

Measure	Time frame	Description
neurocognitive function	1 years	delayed recall using Hopkins Verbal Learning Test

Secondary

Measure	Time frame	Description
quality of life	2 years	Mini-Mental State Examination
patient-reported quality of life	2 years	Spitzer Quality of Life Index
time to intracranial progression	2 years	—
overall survival after brain metastases	2.5 years	—

Countries

China

Contacts

Primary ContactZheng Jiang

keyan307@163.com861066947017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026