CompletedPhase 2

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

Australia20 participantsStarted 2001-09

Plain-language 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.

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Satisfactory recruitment

Timeframe: 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.

Timeframe: 28 days

Trial details

NCT IDNCT00193869

SponsorTrans Tasman Radiation Oncology Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Spinal Cord Compression From Neoplasm Metastasis trials