Back to resultsHippocampal-sparing Whole Brain Radiotherapy for Brain Metastases From Breast Cancer
Primary Purpose
Breast Cancer Metastatic, Brain Metastases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
whole brain radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Metastatic focused on measuring Breast cancer, Brain metastasis, Whole brain radiotherapy, Hippocampal avoidance, Neurocognitive function, intracranial failure
Eligibility 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.
Sites / Locations
- Affiliated Hospital of Academy of Military Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Whole-brain radiotherapy (WBRT) group
Hippocampal-sparing WBRT (HS-WBRT) group
Arm Description
Conventional whole-brain radiotherapy for brain metastases from breast cancer with dose of 37.5 Gy in 15 fractions.
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.
Outcomes
Primary Outcome Measures
neurocognitive function
delayed recall using Hopkins Verbal Learning Test
Secondary Outcome Measures
quality of life
Mini-Mental State Examination
patient-reported quality of life
Spitzer Quality of Life Index
time to intracranial progression
overall survival after brain metastases
Full Information
NCT ID
NCT03002532
First Posted
December 20, 2016
Last Updated
December 21, 2016
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03002532
Brief Title
Hippocampal-sparing Whole Brain Radiotherapy for Brain Metastases From Breast Cancer
Official Title
Whole Brain Irradiation With Hippocampal Sparing for Brain Metastases From Breast Cancer: Neurocognitive Function and Prognosis Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Metastatic, Brain Metastases
Keywords
Breast cancer, Brain metastasis, Whole brain radiotherapy, Hippocampal avoidance, Neurocognitive function, intracranial failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whole-brain radiotherapy (WBRT) group
Arm Type
Active Comparator
Arm Description
Conventional whole-brain radiotherapy for brain metastases from breast cancer with dose of 37.5 Gy in 15 fractions.
Arm Title
Hippocampal-sparing WBRT (HS-WBRT) group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
whole brain radiotherapy
Primary Outcome Measure Information:
Title
neurocognitive function
Description
delayed recall using Hopkins Verbal Learning Test
Time Frame
1 years
Secondary Outcome Measure Information:
Title
quality of life
Description
Mini-Mental State Examination
Time Frame
2 years
Title
patient-reported quality of life
Description
Spitzer Quality of Life Index
Time Frame
2 years
Title
time to intracranial progression
Time Frame
2 years
Title
overall survival after brain metastases
Time Frame
2.5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Jiang
Phone
861066947017
Email
keyan307@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Sun, M.D.
Organizational Affiliation
Affiliated Hospital of Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Academy of Military Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Jiang
Phone
861066947017
Email
keyan307@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26674923
Citation
Sun B, Huang Z, Wu S, Shen G, Cha L, Meng X, Ding L, Wang J, Song S. Incidence and relapse risk of intracranial metastases within the perihippocampal region in 314 patients with breast cancer. Radiother Oncol. 2016 Jan;118(1):181-6. doi: 10.1016/j.radonc.2015.11.010. Epub 2015 Dec 7.
Results Reference
result
PubMed Identifier
27659537
Citation
Sun B, Huang Z, Wu S, Ding L, Shen G, Cha L, Wang J, Song S. Cystic brain metastasis is associated with poor prognosis in patients with advanced breast cancer. Oncotarget. 2016 Nov 8;7(45):74006-74014. doi: 10.18632/oncotarget.12176.
Results Reference
result
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Hippocampal-sparing Whole Brain Radiotherapy for Brain Metastases From Breast Cancer
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