Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
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.
Conditions
This trial is treating people with 1-5 brain metastases
Eligibility
Inclusion
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
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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
William Buckland Radiotherapy Centre
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.
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