Study to assess the neurological and cognitive effects of using Hypofractionated Stereotactic Radiotherapy used to treat multiple (3-10) brain metastases.

Phase 2

• Conditions: eurocognitive impairment; Neurocognitive impairment; Cancer - Any cancer; Cancer - Brain

• Registration Number: ACTRN12615001202550
• Lead Sponsor: Icon Cancer Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-05
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Pathological evidence of a known non-haematological malignancy within 5 years of enrolment.
• Three to ten metastatic brain lesions or surgical cavities which correlate with the confirmed non-haematological malignancy.
• Total Planning Target Volume <15cc for single or three fraction treatment and <35cc for fractionated treatment (five fractions).
• Largest single Planning Target Volume of unresected disease <10cc
• Largest single Planning Target Volume of a resection cavity <15 cc
• Age >18years
• Participants 60 years of age or older must nominate a friend or relative whom will participate in the cognitive decline questionnaire sub-study.
• Must be sufficiently proficient in English to complete neuropsychology tests

Exclusion Criteria

• Cognitive impairment which may interfere with ability to participate in the neurocognitive assessments
• Untreated clinically significant hydrocephalus
• Haematological, Small cell, Germ Cell malignancy or unknown primary tumour
• Leptomeningeal disease
• Multiple new cranial nerve deficits in the absence of overt intracranial disease
• Prior cranial irradiation which would compromise safety if overlapped with protocol treatment
• Contra-indication for MRI and gadolinium contrast use:
o Participants with a known risk of poor renal function must have an estimated Glomerular Filtration Rate >50 millilitres per minute
o Known hypersensitivity to Gadolinium contrast
o Non-MRI compatible VP shunt/surgical apparatus
o Pacemaker/cardiac defibrillator not MRI compatible
• Contra-indications to steroid support (e.g. active peptic ulceration or previous steroid psychosis)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurocognitive functioning as measured by the Hopkins Verbal Learning Test (HVTL)[ Three months post-treatment, compared to baseline]