Clinical trial · Interventional
SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).
A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy
NCT00193869CI-TRIAL-00000723completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spinal Cord Compression From Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Satisfactory recruitment
- timeFrame
- Failure to accrue 30 patients in 15 months will initiate early closure of this study.
- measure
- Acceptable steroid toxicity rate at 28 days with reference to baseline.
- timeFrame
- 28 days
Secondary outcomes (5)
- measure
- Ambulation rates at 1 month
- timeFrame
- 1 month
- measure
- Barthel Index
- timeFrame
- Final analysis when all patients have been followed for 1 month
- measure
- Functional Independence (FIM)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTGraham 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. PMID 16477923