NCT03002532

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

2 years

First QC Date

December 20, 2016

Last Update Submit

December 21, 2016

Conditions

Breast Cancer MetastaticBrain Metastases

Keywords

Breast cancerBrain metastasisWhole brain radiotherapyHippocampal avoidanceNeurocognitive functionintracranial failure

Outcome Measures

Primary Outcomes (1)

  • neurocognitive function

    delayed recall using Hopkins Verbal Learning Test

    1 years

Secondary Outcomes (4)

  • quality of life

    2 years

  • patient-reported quality of life

    2 years

  • time to intracranial progression

    2 years

  • overall survival after brain metastases

    2.5 years

Study Arms (2)

Whole-brain radiotherapy (WBRT) group

ACTIVE COMPARATOR

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

Radiation: whole brain radiotherapy

Hippocampal-sparing WBRT (HS-WBRT) group

EXPERIMENTAL

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

Interventions

whole brain radiotherapyRADIATION
Hippocampal-sparing WBRT (HS-WBRT) groupWhole-brain radiotherapy (WBRT) group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26674923RESULT

  • 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.

    PMID: 27659537RESULT

MeSH Terms

Conditions

Brain NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bing Sun, M.D.

    Affiliated Hospital of Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Jiang

CONTACT

861066947017keyan307@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 23, 2016

Study Start

August 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

December 23, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)