A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy
Malignant spinal cord compression (MSCC) is an uncommon condition with an estimated annual
incidence of 2.5 per 100,000. It is a dreaded complication of malignancy because of the
severe impact paralysis and sphincter disturbance has on quality and duration of survival.
Rat models have demonstrated the effectiveness of high doses of steroids. Only three
randomised controlled trials (RCTs) have been published. The first compared radiotherapy to
laminectomy plus radiotherapy in a series of 29 patients and failed to show any significant
differences The widespread commonly used dose of Dexamethasone in Australia at that time
was 16 mg/24 hr and the main concern for implementing higher doses was the toxicity profile
reported in the few small randomised comparisons available at the time.In view of the
conflict between standard Australian practice versus published (overseas) guidelines, a
randomised comparison was proposed in Australia. This study was a pilot study initiated to
determine the viability of a large trial, to pilot the use of web technology for trial
conduct and to determine clinically useful outcome measures apart from simple ambulation
Comparisons: Patients randomised to receive either 16mg/24hr or 96mg/24hr dexamethasone.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Failure to accrue 30 patients in 15 months will initiate early closure of this study.
Peter Graham, FRANZCR
St George Hospital
Australia: Department of Health and Ageing Therapeutic Goods Administration