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

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT03002532

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Metastatic Brain Metastases	Radiation: whole brain radiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2017

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Whole-brain radiotherapy (WBRT) group Conventional whole-brain radiotherapy for brain metastases from breast cancer with dose of 37.5 Gy in 15 fractions.	Radiation: whole brain radiotherapy
Experimental: Hippocampal-sparing WBRT (HS-WBRT) group 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

Arm

Intervention/Treatment

Active Comparator: Whole-brain radiotherapy (WBRT) group

Conventional whole-brain radiotherapy for brain metastases from breast cancer with dose of 37.5 Gy in 15 fractions.

Radiation: whole brain radiotherapy

Experimental: Hippocampal-sparing WBRT (HS-WBRT) group

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

Outcome Measures

Primary Outcome Measures

neurocognitive function [1 years]
delayed recall using Hopkins Verbal Learning Test

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts 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.