NCT00193869

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

May 10, 2007

Status Verified

May 1, 2007

First QC Date

September 11, 2005

Last Update Submit

May 8, 2007

Conditions

Spinal Cord Compression From Neoplasm Metastasis

Keywords

RadiotherapyDose fractionation

Outcome Measures

Primary Outcomes (2)

  • Satisfactory recruitment

    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.

    28 days

Secondary Outcomes (5)

  • Ambulation rates at 1 month

    1 month

  • Barthel Index

    Final analysis when all patients have been followed for 1 month

  • Functional Independence (FIM)

    Final analysis when all patients have been followed for 1 month

  • Functional Improvement Score (FIS)within 2 weeks with reference to baseline

    2 weeks

  • Pain

    Final analysis when all patients have been followed for 1 month

Interventions

DexamethasoneDRUG

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Related 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 Oncol (R Coll Radiol). 2006 Feb;18(1):70-6. doi: 10.1016/j.clon.2005.08.015.

    PMID: 16477923RESULT

Related Links

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Peter Graham, FRANZCR

    St George Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

September 1, 2001

Study Completion

December 1, 2003

Last Updated

May 10, 2007

Record last verified: 2007-05

Locations

AU(1)