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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer Metastatic, Brain Metastases

Intervention / Treatment
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* Radiation: whole brain radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whole-brain radiotherapy (WBRT) group<br>Conventional whole-brain radiotherapy for brain metastases from breast cancer with dose of 37.5 Gy in 15 fractions. | Radiation: whole brain radiotherapy<br> <br> |
| Experimental: Hippocampal-sparing WBRT (HS-WBRT) group<br>Hippocampal-sparing whole brain radiotherapy is performed using modern intensity-modulated radiotherapy (IMRT) technique to avoid conformally the hippocampal neural stem-cell structure during WBRT. Prescription dose is 37.5 Gy in 15 fractions. | Radiation: whole brain radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurocognitive function | delayed recall using Hopkins Verbal Learning Test | 1 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Brain metastasis, Whole brain radiotherapy, Hippocampal avoidance, Neurocognitive function, intracranial failure