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SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).

Primary Purpose

Spinal Cord Compression From Neoplasm Metastasis

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Trans Tasman Radiation Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Compression From Neoplasm Metastasis focused on measuring Radiotherapy, Dose fractionation

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St George Hospital

Outcomes

Primary Outcome Measures

Satisfactory recruitment
Acceptable steroid toxicity rate at 28 days with reference to baseline.

Secondary Outcome Measures

Ambulation rates at 1 month
Barthel Index
Functional Independence (FIM)
Functional Improvement Score (FIS)within 2 weeks with reference to baseline
Pain

Full Information

First Posted
September 11, 2005
Last Updated
May 8, 2007
Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
Cancer Council New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT00193869
Brief Title
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

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
Cancer Council New South Wales

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Compression From Neoplasm Metastasis
Keywords
Radiotherapy, Dose fractionation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
Satisfactory recruitment
Time Frame
Failure to accrue 30 patients in 15 months will initiate early closure of this study.
Title
Acceptable steroid toxicity rate at 28 days with reference to baseline.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Ambulation rates at 1 month
Time Frame
1 month
Title
Barthel Index
Time Frame
Final analysis when all patients have been followed for 1 month
Title
Functional Independence (FIM)
Time Frame
Final analysis when all patients have been followed for 1 month
Title
Functional Improvement Score (FIS)within 2 weeks with reference to baseline
Time Frame
2 weeks
Title
Pain
Time Frame
Final analysis when all patients have been followed for 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Graham, FRANZCR
Organizational Affiliation
St George Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
16477923
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.
Results Reference
result
Links:
URL
http://www.trog.com.au
Description
Click here for more information about this study on the TROG official website

Learn more about this trial

SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).

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