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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00193869




Registration number
NCT00193869
Ethics application status
Date submitted
11/09/2005
Date registered
19/09/2005
Date last updated
10/05/2007

Titles & IDs
Public title
SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).
Scientific title
A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy
Secondary ID [1] 0 0
TROG 01.05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Compression From Neoplasm Metastasis 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Satisfactory recruitment
Timepoint [1] 0 0
Failure to accrue 30 patients in 15 months will initiate early closure of this study.
Primary outcome [2] 0 0
Acceptable steroid toxicity rate at 28 days with reference to baseline.
Timepoint [2] 0 0
28 days
Secondary outcome [1] 0 0
Ambulation rates at 1 month
Timepoint [1] 0 0
1 month
Secondary outcome [2] 0 0
Barthel Index
Timepoint [2] 0 0
Final analysis when all patients have been followed for 1 month
Secondary outcome [3] 0 0
Functional Independence (FIM)
Timepoint [3] 0 0
Final analysis when all patients have been followed for 1 month
Secondary outcome [4] 0 0
Functional Improvement Score (FIS)within 2 weeks with reference to baseline
Timepoint [4] 0 0
2 weeks
Secondary outcome [5] 0 0
Pain
Timepoint [5] 0 0
Final analysis when all patients have been followed for 1 month

Eligibility
Key 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
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2003
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Council New South Wales
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Graham, FRANZCR
Address 0 0
St George Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Graham PH, Capp A, Delaney G, Goozee G, Hickey B, ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00193869