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

Trans Tasman Radiation Oncology Group

Status and phase

Completed

Phase 2

Conditions

Spinal Cord Compression From Neoplasm Metastasis

Treatments

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT00193869

TROG 01.05

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

17+ years old

Volunteers

No 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