Status:
COMPLETED
SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Cancer Council New South Wales
Conditions:
Spinal Cord Compression From Neoplasm Metastasis
Eligibility:
All Genders
17+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 paralys...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00193869
Start Date
September 1 2001
End Date
December 1 2003
Last Update
May 10 2007
Active Locations (1)
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1
St George Hospital
Kogarah, New South Wales, Australia, 2217