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

This study is currently recruiting participants.
Verified December 2016 by Affiliated Hospital to Academy of Military Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT03002532
First Posted: December 23, 2016
Last Update Posted: December 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences
  Purpose
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 Intervention
Breast Cancer Metastatic Brain Metastases Radiation: whole brain radiotherapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Affiliated Hospital to Academy of Military Medical Sciences:

Primary Outcome Measures:
  • neurocognitive function [ Time Frame: 1 years ]
    delayed recall using Hopkins Verbal Learning Test


Secondary Outcome Measures:
  • quality of life [ Time Frame: 2 years ]
    Mini-Mental State Examination

  • patient-reported quality of life [ Time Frame: 2 years ]
    Spitzer Quality of Life Index

  • time to intracranial progression [ Time Frame: 2 years ]
  • overall survival after brain metastases [ Time Frame: 2.5 years ]

Estimated Enrollment: 120
Study Start Date: August 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002532


Contacts
Contact: Zheng Jiang 861066947017 keyan307@163.com

Locations
China, Beijing
Affiliated Hospital of Academy of Military Medical Sciences Recruiting
Beijing, Beijing, China, 100071
Contact: Zheng Jiang    861066947017    keyan307@163.com   
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Investigators
Principal Investigator: Bing Sun, M.D. Affiliated Hospital of Academy of Military Medical Sciences
  More Information

Publications:
Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT03002532     History of Changes
Other Study ID Numbers: ky-2016-9-37
First Submitted: December 20, 2016
First Posted: December 23, 2016
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
Breast cancer
Brain metastasis
Whole brain radiotherapy
Hippocampal avoidance
Neurocognitive function
intracranial failure

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases