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

Affiliated Hospital to Academy of Military Medical Sciences

Status: Unknown

Conditions: Brain Metastases; Breast Cancer Metastatic

Treatments: Radiation: whole brain radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03002532

ky-2016-9-37

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Whole-brain radiotherapy (WBRT) group

Active Comparator group

Description:

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

Treatment:

Radiation: whole brain radiotherapy

Hippocampal-sparing WBRT (HS-WBRT) group

Experimental group

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.

Treatment:

Radiation: whole brain radiotherapy