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

Phase 2

Active, not recruiting

• Conditions: Brain metastases; Cancer - Any cancer

• Registration Number: ACTRN12615000329561
• Lead Sponsor: William Buckland Radiotherapy Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-10
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes or development of symptoms post-stereotactic radiotherapy (SRT) to brain metastases <br><br>Instrument: MD Anderson Symptom Inventory - Brain Tumor questionnaire: mean Symptom Severity and Symptom Interference subscales[On the first day of SRT (pre-treatment) and days 1, 2, and 7 post-treatment]

Secondary Outcome Measures

Name	Time	Method
Rate of initiation of dexamethasone <br><br>Assessed by the proportion of patients in each treatment arm who required initiation of dexamethasone[First 30 days following commencement of stereotactic radiotherapy ];Predictive factors for initiation of dexamethasone<br><br>Pre-determined factors would be evaluated for association with initiation of dexamethasone.<br>(factors: planned target volume, extent of oedema, number of treated brain metastases, presence of midline shift, presence of impingment of ventricles, tumour location, symptom score pre-treatment, V12 Gy)[First 30 days following commencement of stereotactic radiotherapy to brain metastases];Health-related quality of life<br><br>Instrument: EORTC QLQ-C30 and Brain Cancer Module BN-20; raw scores transformed to scaled scores ranging 0-100[Baseline, Day 7 post-treatment, and 3- and 6- month follow up]