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

December 21, 2016 updated by: Affiliated Hospital to Academy of Military Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Recruiting
        • Affiliated Hospital of Academy of Military Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Bing Sun, M.D., Affiliated Hospital of Academy of Military Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 21, 2016

First Posted (Estimate)

December 23, 2016

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ky-2016-9-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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