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Clinical Trials/ACTRN12615000329561
ACTRN12615000329561Active, not recruitingPhase 2

Double-blinded randomised trial of prophylactic dexamethasone versus placebo in stereotactic radiotherapy to 1-5 brain metastases, assessing symptomatology and quality of life.

William Buckland Radiotherapy Centre0 sites64 target enrollmentStarted: April 10, 2015Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Enrollment
64

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Prevention
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to o limit (—)
Sex
All

Inclusion Criteria

  • 1Number of brain metastases – 1-5 brain metastases (as defined on the MRI brain); at least one lesion planned for SRT
  • 2Non-primary brain tumour
  • 3ECOG performance status 0-2
  • 4Expected life expectancy of >6 months
  • 5Not on dexamethasone for at least 7 days preceding treatment
  • 6Willing or able to complete questionnaires by themselves
  • 7Willing to be contacted by the study investigators in first 30 days following treatment for follow up

Exclusion Criteria

  • 1More than 5 untreated brain metastases
  • 2Leptomeningeal metastases
  • 3Contraindications or comorbidities which may be seriously affected by dexamethasone – uncontrolled diabetes, previous psychosis secondary to dexamethasone
  • 4Inability to complete MRI
  • 5Planned cytotoxic chemotherapy during SRT
  • 6Other tumour types – primary germ cell tumour, small cell carcinoma, haematological malignancies
  • 7Brain metastases unsuitable for SRT (eg: located <2 mm of the optic chiasm)
  • 8Pregnant or lactating women
  • 9Men or women of childbearing potential who are unwilling to employ adequate contraception throughout study

Investigators

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