Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Dexamethasone

Treatment: Drugs: Dexamethasone
Intervention code [1] 0 0
Treatment: Drugs
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00193869
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00193869