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

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Collaborator: Cancer Council New South Wales
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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