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

Not Applicable

• Conditions: Breast Cancer Metastatic; Brain Metastases
• Interventions: Radiation: whole brain radiotherapy

• Registration Number: NCT03002532
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Status Verified: 2016-12
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-21
• Last Update Submitted: 2016-12-21
• Study First Posted: 2016-12-23
• Last Update Posted: 2016-12-23
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hippocampal-sparing WBRT (HS-WBRT) group	whole brain radiotherapy	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.
Whole-brain radiotherapy (WBRT) group	whole brain radiotherapy	Conventional whole-brain radiotherapy for brain metastases from breast cancer with dose of 37.5 Gy in 15 fractions.

Primary Outcome Measures

Name	Time	Method
neurocognitive function	1 years	delayed recall using Hopkins Verbal Learning Test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Affiliated Hospital of Academy of Military Medical Sciences; 🇨🇳 Beijing, Beijing, China