Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193869
Status:
COMPLETED
Last Update Posted:
2007-05-10
First Post:
2005-09-11
Brief Title:
SuperDEX Trial Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Trans Tasman Radiation Oncology Group
Study Overview
Official Title:
A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 per 100000 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 mg24 hr and the main concern for implementing higher doses was the toxicity profile reported in the few small randomised comparisons available at the timeIn 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 16mg24hr or 96mg24hr dexamethasone
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 mg24 hr and the main concern for implementing higher doses was the toxicity profile reported in the few small randomised comparisons available at the timeIn 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 16mg24hr or 96mg24hr dexamethasone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None