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

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03002532
• Other study ID #: ky-2016-9-37
• Status: Recruiting
• Phase: N/A
• First received: December 20, 2016
• Last updated: December 21, 2016
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: December 2016
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Zheng Jiang
• Phone: 861066947017
• Email: keyan307[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Breast Cancer Metastatic
• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Radiation:
• whole brain radiotherapy

Locations

Country	Name	City	State
China	Affiliated Hospital of Academy of Military Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (2)

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 Sep 21. doi: 10.18632/oncotarget.12176. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurocognitive function	delayed recall using Hopkins Verbal Learning Test	1 years	No
Secondary	quality of life	Mini-Mental State Examination	2 years	No
Secondary	patient-reported quality of life	Spitzer Quality of Life Index	2 years	No
Secondary	time to intracranial progression		2 years	No
Secondary	overall survival after brain metastases		2.5 years	No