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

Phase 2
17 Years
Not Enrolling
Spinal Cord Compression From Neoplasm Metastasis

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Trial Information

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

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

Comparisons: Patients randomised to receive either 16mg/24hr or 96mg/24hr dexamethasone.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Satisfactory recruitment

Outcome Time Frame:

Failure to accrue 30 patients in 15 months will initiate early closure of this study.

Principal Investigator

Peter Graham, FRANZCR

Investigator Role:

Study Chair

Investigator Affiliation:

St George Hospital


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

TROG 01.05



Start Date:

September 2001

Completion Date:

December 2003

Related Keywords:

  • Spinal Cord Compression From Neoplasm Metastasis
  • Radiotherapy
  • Dose fractionation
  • Neoplasms
  • Neoplasm Metastasis
  • Spinal Cord Compression