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

• Register: ANZCTR
• Last refreshed on: 9 August 2022
• Main ID: ACTRN12615000329561
• Date of registration: 10/04/2015
• Prospective Registration: Yes
• Primary sponsor: William Buckland Radiotherapy Centre
• Public title: Double-blinded randomised trial of prophylactic dexamethasone versus placebo in stereotactic radiotherapy to 1-5 brain metastases
• Scientific title: Double-blinded randomised trial of prophylactic dexamethasone versus placebo in stereotactic radiotherapy to 1-5 brain metastases, assessing symptomatology and quality of life.
• Date of first enrolment: 24/04/2015
• Target sample size: 64
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12615000329561.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Dr Jeremy Ruben

• Name: Dr Jeremy Ruben

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Any cancer

Brain metastases;
Brain metastases

Intervention(s)

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.

Primary Outcome(s)

Changes or development of symptoms post-stereotactic radiotherapy (SRT) to brain metastases

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(s)

Rate of initiation of dexamethasone

Assessed by the proportion of patients in each treatment arm who required initiation of dexamethasone[First 30 days following commencement of stereotactic radiotherapy ]

Health-related quality of life

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]

Predictive factors for initiation of dexamethasone

Pre-determined factors would be evaluated for association with initiation of dexamethasone.
(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]

Secondary ID(s)

Nil

Source(s) of Monetary Support

William Buckland Radiotherapy Centre

Ethics review

Status: Approved
Approval date: 06/03/2015
Contact:

Alfred Health Ethics Committee

Status: Not approved
Approval date:
Contact:

Princess Alexandra Hospital Ethics Committee

Results

• Date Posted: 28/07/2022