Clinical trial NCT00193869: SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).
Official title: A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Compression From Neoplasm Metastasis
Keywords: Radiotherapy
Dose fractionation
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
Collaborators: name: Cancer Council New South Wales
First posted: 2005-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Australia, to test web registration and randomisation and to compare different functional outcome measures.

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 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.

Eligibility criteria: 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

Primary outcomes:
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:
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)
timeFrame: Final analysis when all patients have been followed for 1 month
measure: Functional Improvement Score (FIS)within 2 weeks with reference to baseline
timeFrame: 2 weeks
measure: Pain
timeFrame: Final analysis when all patients have been followed for 1 month
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
Study officials:
affiliation: St George Hospital
name: Peter Graham, FRANZCR
role: STUDY_CHAIR
References:
citation: 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.