SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).
NCT ID: NCT00193869
Last Updated: 2007-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2001-09-30
2003-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Dexamethasone
Eligibility Criteria
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Inclusion Criteria
* 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 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
17 Years
ALL
No
Sponsors
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Trans Tasman Radiation Oncology Group
OTHER
Cancer Council New South Wales
OTHER
Principal Investigators
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Peter Graham, FRANZCR
Role: STUDY_CHAIR
St George Hospital
Locations
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St George Hospital
Kogarah, New South Wales, Australia
Countries
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References
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Graham PH, Capp A, Delaney G, Goozee G, Hickey B, Turner S, Browne L, Milross C, Wirth A. A pilot randomised comparison of dexamethasone 96 mg vs 16 mg per day for malignant spinal-cord compression treated by radiotherapy: TROG 01.05 Superdex study. Clin Oncol (R Coll Radiol). 2006 Feb;18(1):70-6. doi: 10.1016/j.clon.2005.08.015.
Related Links
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Click here for more information about this study on the TROG official website
Other Identifiers
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TROG 01.05
Identifier Type: -
Identifier Source: org_study_id