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

This study has been completed.
Sponsor:
Collaborator:
Cancer Council New South Wales
Information provided by:
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00193869
First received: September 11, 2005
Last updated: May 8, 2007
Last verified: May 2007
  Purpose

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 Intervention Phase
Spinal Cord Compression From Neoplasm Metastasis
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Satisfactory recruitment [ Time Frame: 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. [ Time Frame: 28 days ]

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

Enrollment: 20
Study Start Date: September 2001
Study Completion Date: December 2003
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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193869

Locations
Australia, New South Wales
St George Hospital
Kogarah, New South Wales, Australia, 2217
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Cancer Council New South Wales
Investigators
Study Chair: Peter Graham, FRANZCR St George Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00193869     History of Changes
Other Study ID Numbers: TROG 01.05
Study First Received: September 11, 2005
Last Updated: May 8, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Radiotherapy
Dose fractionation

Additional relevant MeSH terms:
Neoplasm Metastasis
Spinal Cord Compression
Central Nervous System Diseases
Neoplasms
Neoplastic Processes
Nervous System Diseases
Pathologic Processes
Spinal Cord Diseases
Spinal Cord Injuries
Wounds and Injuries
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014