SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy

Conditions
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Spinal Cord Compression From Neoplasm Metastasis

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malignant spinal cord compression with at least one of pain, weakness, sensory disturbance or sphincter disturbance Histology not required if prior biopsy proven malignancy Any stage Age >16 years ECOG 1-3 prior to cord compression event Minimum power 1 of 5 point scale Must not be paraplegic Minimum expected survival 2 months Relevant minimum lab values Patients capable of childbearing using adequate contraception Written informed consent Exclusion Criteria: Prior radiotherapy to within vertebral±one level affected by cord compression Prior treatment for spinal cord compression at the current level Histology is lymphoma or myeloma Power less than 1 of 5 More than 12 hours after initiation of dexamethasone>4mg/24hr Pre-existing co-morbid conditions - peptic ulceration or cardiac failure Allergy to study medications Multilevel cord compression or meningeal carcinomatosis Pregnant or lactating

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dexamethasone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfactory recruitment |  | 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. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulation rates at 1 month |  | 1 month | 
| Barthel Index |  | Final analysis when all patients have been followed for 1 month | 
| Functional Independence (FIM) |  | Final analysis when all patients have been followed for 1 month | 
| Functional Improvement Score (FIS)within 2 weeks with reference to baseline |  | 2 weeks | 
| Pain |  | Final analysis when all patients have been followed for 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Dose fractionation