Clinical trial NCT03002532: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Metastatic
Brain Metastases
Keywords: Breast cancer
Brain metastasis
Whole brain radiotherapy
Hippocampal avoidance
Neurocognitive function
intracranial failure
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: neurocognitive function
timeFrame: 1 years
Secondary outcomes:
measure: quality of life
timeFrame: 2 years
measure: patient-reported quality of life
timeFrame: 2 years
measure: time to intracranial progression
timeFrame: 2 years
measure: overall survival after brain metastases
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Hospital of Academy of Military Medical Sciences
state: Beijing
Study officials:
affiliation: Affiliated Hospital of Academy of Military Medical Sciences
name: Bing Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.