Spinal Cord Compression From Neoplasm MetastasisPhase 2NCT00193869
SuperDEX Trial (Comparison of Two Doses of Dexamethasone for Malignant Spinal Cord Compression Treated by Radiotherapy).
A Phase 2 study testing Dexamethasone in people with Spinal Cord Compression From Neoplasm Metastasis, run by Trans Tasman Radiation Oncology Group at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Spinal Cord Compression From Neoplasm Metastasis
- What is being tested?
- Dexamethasone
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2001to Dec 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- Minimum expected survival 2 months
- Relevant minimum lab values
- Patients capable of childbearing using adequate contraception
- Written informed consent
Who cannot join
- 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
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- Allergy to study medications
- Multilevel cord compression or meningeal carcinomatosis
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy
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.
Read the 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.
- Being tested
- Dexamethasone
- Keywords
- Radiotherapy, Dose fractionation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfactory recruitment
Measured: 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.
Measured: 28 days
Secondary outcomes (5)
Ambulation rates at 1 month
Measured: 1 month
Barthel Index
Measured: Final analysis when all patients have been followed for 1 month
Functional Independence (FIM)
Measured: Final analysis when all patients have been followed for 1 month
Functional Improvement Score (FIS)within 2 weeks with reference to baseline
Measured: 2 weeks
Pain
Measured: Final analysis when all patients have been followed for 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2001
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Compression From Neoplasm MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Council New South Wales
- Investigators
- Peter Graham, FRANZCR, Study chair, St. George's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193869
- Sponsor's protocol ID
- TROG 01.05
- Status last verified
- May 2007
- First submitted
- 11 Sep 2005
- Last updated
- 10 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16477923
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy
- ClinicalTrials.gov ID
- NCT00193869
- Acronym / sponsor ID
- TROG 01.05
- Keywords
- Radiotherapy, Dose fractionation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- Cancer Council New South Wales
- Study start
- Sep 2001
- Study completion
- Dec 2003 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone | Drug | – |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2007.
- Results publication: PubMed 16477923Graham 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.
- Click here for more information about this study on the TROG official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Graham, FRANZCR study chair
St. George's Hospital, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone in people with Spinal Cord Compression From Neoplasm Metastasis, run by Trans Tasman Radiation Oncology Group at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfactory recruitment (time frame: Failure to accrue 30 patients in 15 months will initiate early closure of this study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00193869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2007.