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

May 8, 2007 updated by: Trans Tasman Radiation Oncology Group

A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Satisfactory recruitment
Time Frame: Failure to accrue 30 patients in 15 months will initiate early closure of this study.
Failure to accrue 30 patients in 15 months will initiate early closure of this study.
Acceptable steroid toxicity rate at 28 days with reference to baseline.
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Ambulation rates at 1 month
Time Frame: 1 month
1 month
Barthel Index
Time Frame: Final analysis when all patients have been followed for 1 month
Final analysis when all patients have been followed for 1 month
Functional Independence (FIM)
Time Frame: Final analysis when all patients have been followed for 1 month
Final analysis when all patients have been followed for 1 month
Functional Improvement Score (FIS)within 2 weeks with reference to baseline
Time Frame: 2 weeks
2 weeks
Pain
Time Frame: Final analysis when all patients have been followed for 1 month
Final analysis when all patients have been followed for 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trans Tasman Radiation Oncology Group

Collaborators

Cancer Council New South Wales

Investigators

  • Study Chair: Peter Graham, FRANZCR, St George Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

May 10, 2007

Last Update Submitted That Met QC Criteria

May 8, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROG 01.05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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