Double-blinded randomised trial of prophylactic dexamethasone versus placebo in stereotactic radiotherapy to 1-5 brain metastases

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000329561

Acronym

Stereodex Trial

Enrollment

Registered

2015-04-10

Start date

2015-04-24

Completion date

2022-04-26

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Update This study aims to assess if dexamethasone influences the development of symptoms, if any during stereotactic radiotherapy (SRT) to brain metastases. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have 1-5 brain metastases with at least one lesion planned for SRT, and not on dexamethasone for at least 7 days prior to SRT. Study details: There are no clear guidelines on who would benefit from prophylactic (ie. as a precaution before any symptoms develop) dexamethasone during SRT to brain metastases. Some clinicians may choose to prescribe prophylactic dexamethasone to prevent or minimize any local swelling during radiotherapy. Others may not, as not all patients will develop symptoms. To evaluate this, we are randomising patients to having 4 mg oral dexamethasone (on days of SRT and 1 day after) or placebo. We are also studying the effect of treatment on patient’s quality of life. It is hypothesised that patients in the placebo arm may develop symptoms following SRT. The results of the study will guide clinicians whether prophylactic dexamethasone is beneficial in a selected group of patients having stereotactic radiation for brain metastases.

Interventions

Dexamethasone 4 mg orally daily on day(s) of stereotactic radiotherapy (SRT) and one day after (ie. 2 or 4 days, depending on duration of prescribed SRT) Instructions will be provided to participant on prescription. Verbal reinforcement will also be available during routine treatment reviews.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results