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

Spinal Cord Compression From Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193869
• Other study ID #: TROG 01.05
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2005
• Last updated: May 8, 2007
• Start date: September 2001
• Est. completion date: December 2003

Study information

• Verified date: May 2007
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Cord Compression
• Spinal Cord Compression From Neoplasm Metastasis

Intervention

Drug:
• Dexamethasone

Locations

Country	Name	City	State
Australia	St George Hospital	Kogarah	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)	Cancer Council New South Wales

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Graham PH, Capp A, Delaney G, Goozee G, Hickey B, Turner S, Browne L, Milross C, Wirth A. A pilot randomised comparison of dexamethasone 96 mg vs 16 mg per day for malignant spinal-cord compression treated by radiotherapy: TROG 01.05 Superdex study. Clin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfactory recruitment		Failure to accrue 30 patients in 15 months will initiate early closure of this study.
Primary	Acceptable steroid toxicity rate at 28 days with reference to baseline.		28 days
Secondary	Ambulation rates at 1 month		1 month
Secondary	Barthel Index		Final analysis when all patients have been followed for 1 month
Secondary	Functional Independence (FIM)		Final analysis when all patients have been followed for 1 month
Secondary	Functional Improvement Score (FIS)within 2 weeks with reference to baseline		2 weeks
Secondary	Pain		Final analysis when all patients have been followed for 1 month

External Links

•   Click here for more information about this study on the TROG official website