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

Sponsor

Trans Tasman Radiation Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00193869

Collaborator

Cancer Council New South Wales (Other)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Compression From Neoplasm Metastasis	Drug: Dexamethasone	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2001

Actual Study Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

Satisfactory recruitment [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. [28 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts 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