SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).
The study aimed to pilot the viability of a full scale randomised comparison of 2 steroid doses in malignant spinal cord compression, to establish safety of high dose dexamethasone in this setting in Australia, to test web registration and randomisation and to compare different functional outcome measures.
Spinal Cord Compression From Neoplasm Metastasis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy|
- Satisfactory recruitment [ Time Frame: Failure to accrue 30 patients in 15 months will initiate early closure of this study. ]
- Acceptable steroid toxicity rate at 28 days with reference to baseline. [ Time Frame: 28 days ]
- Ambulation rates at 1 month [ Time Frame: 1 month ]
- Barthel Index [ Time Frame: Final analysis when all patients have been followed for 1 month ]
- Functional Independence (FIM) [ Time Frame: Final analysis when all patients have been followed for 1 month ]
- Functional Improvement Score (FIS)within 2 weeks with reference to baseline [ Time Frame: 2 weeks ]
- Pain [ Time Frame: Final analysis when all patients have been followed for 1 month ]
|Study Start Date:||September 2001|
|Study Completion Date:||December 2003|
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 rates.
Comparisons: Patients randomised to receive either 16mg/24hr or 96mg/24hr dexamethasone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193869
|Australia, New South Wales|
|St George Hospital|
|Kogarah, New South Wales, Australia, 2217|
|Study Chair:||Peter Graham, FRANZCR||St George Hospital|