Pilot study of Hippocampal Avoidance Technique for Whole Brain Radiotherapy in stage IV breast cancer with brain metastases

Not Applicable

• Conditions: Breast Cancer; Brain Metastases; Cancer - Breast; Cancer - Brain

• Registration Number: ACTRN12617000138381
• Lead Sponsor: Genesis Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-25
• Study Completion: 2019-01-01
• Last Update Posted: 28 January 2019

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

1)Signed informed consent
2)Pathologically proven diagnosis of breast cancer
3)Stage IV disease with brain metastases which are outside of a 5 mm margin around either hippocampus
4)Stable or responsive extracranial disease as assessed by the patient’s medical oncologist
5)ECOG 0-2
6)Suitable for treatment with WBRT
7)Non-pregnant women aged over 18 years
8)Patients able to sufficiently cooperate with the proposed study requirements
9)Brain metastases that have previously been managed with surgical resection or stereotactic radiosurgery are permitted

Exclusion Criteria

1)Life expectancy anticipated to be equal to or less than 12 weeks
2)Brain metastases within a 5mm margin of either hippocampus
3)Leptomeningeal disease
4)Pregnant women or women of child bearing age who do not wish to use contraception during radiotherapy treatment
5)Patients with significant psychological or psychiatric comorbidity
6)All cytotoxic chemotherapy must be withheld from 21 days before starting HAT WBRT, during HAT WBRT delivery and for 30 days after delivery of HAT WBRT

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be neurocognitive function as assessed by the Hopkins Verbal Learning Test revised - Delayed Recall (HVLT DR).[12 months after the completion of radiotherapy]