Spinal Cord CompressionPhase 3NCT00968643
Spinal Cord Compression. ICORG 05-03, V6
A Phase 3 study testing radiation therapy in people with Spinal Cord Compression and Unspecified Adult Solid Tumor, Protocol Specific, run by Cancer Trials Ireland at 4 sites in Ireland.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 4 sitesIreland
- Study dates
- Jan 2006to May 2014
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed malignancy, excluding the following:
- Leukemia
- Myeloma
- Germ cell tumor
- Primary tumor of the spine or vertebral column
- Diagnosis of malignant spinal cord compression confirmed by MRI of the entire spine
- Deemed inoperable or unsuitable for neurosurgical intervention at the time of initial assessment
- No single bone metastasis with controlled primary site
PATIENT CHARACTERISTICS:
- Karnofsky performance status 30-100%
- No medical or psychiatric condition that, in the opinion of the investigator or research team, would contraindicate study participation
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the involved area of the spinal cord such that further treatment exceeds spinal cord tolerance
Trial locations and contacts
4 sites in 1 country.
Ireland4 sites
Cork University Hospital
Cork
Saint Luke's Radiation Oncology Network (SLRON)
Dublin, 6
Galway University Hospital
Galway
Whitfield Cancer Centre at Whitfield Clinic
Waterford
About this study
Official title: A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression.
PURPOSE: This randomized phase III trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression.
Read the detailed description
OBJECTIVES:
Primary
- To compare the response in patients with malignant spinal cord compression treated with single fraction (10 Gy) radiotherapy vs standard multiple fraction (20 Gy) radiotherapy.
- To compare the toxicity of these treatment regimens in these patients.
Secondary
- Examine the safety, practicability, and efficacy of treatment with a single 10 Gy fraction of radiotherapy in these patients.
- Analyze the initial neurological status, document the response to treatment, and calculate median survival of these patients.
- Perform an economic impact analysis comparing the two treatment arms.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
- Arm II: Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
Patients complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, at 5 weeks, and then every 3 months thereafter.
After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.
- Being tested
- radiation therapy
- Keywords
- spinal cord compression, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
Given in multiple fractions or as a single fraction
| Study group | Role | What they receive |
|---|---|---|
| Arm I (control) | Active comparator | Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy). Receives: Radiation: radiation therapy |
| Arm II | Experimental | Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy). Receives: Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
Measured: 5 weeks from date of randomisation
Secondary outcomes (5)
Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire
Measured: 5 weeks from date of randomisation
Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale
Measured: 1 week after completion of therapy
Pain control: assessed using a Visual Analogue Scale
Measured: Until death
Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause
Measured: Until death
Sphincter function: assessed using an 'In-House' Bladder Function Scale
Measured: Until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startJan 2006
- Primary completionMay 2014
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 CompressionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre Thirion, Principal investigator, St Luke's Radiation Oncology Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968643
- Sponsor's protocol ID
- 05-03 ICORG
- Other IDs
- ICORG-05-03, EU-20952
- Status last verified
- Aug 2014
- First submitted
- 28 Aug 2009
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thirion PG, Dunne MT, Kelly PJ, Flavin A, O'Sullivan JM, Hacking D, Sasiadek W, Small C, Pomeroy MM, Martin J, McArdle O, Parker I, O'Sullivan LS, Shannon AM, Clayton-Lea A, Collins CD, Stevenson MR, Alvarez-Iglesias A, Armstrong JG, Moriarty M. Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression. Br J Cancer. 2020 Apr;122(9):1315-1323. doi: 10.1038/s41416-020-0768-z. Epub 2020 Mar 11.
PubMed 32157242
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression
- ClinicalTrials.gov ID
- NCT00968643
- Acronym / sponsor ID
- 05-03 ICORG
- Keywords
- spinal cord compression, unspecified adult solid tumor, protocol specific
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Jan 2006
- Primary completion
- May 2014 (actual)
- First posted
- 31 Aug 2009 (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.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression.
PURPOSE: This randomized phase III trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression.
Detailed description
OBJECTIVES:
Primary
- To compare the response in patients with malignant spinal cord compression treated with single fraction (10 Gy) radiotherapy vs standard multiple fraction (20 Gy) radiotherapy.
- To compare the toxicity of these treatment regimens in these patients.
Secondary
- Examine the safety, practicability, and efficacy of treatment with a single 10 Gy fraction of radiotherapy in these patients.
- Analyze the initial neurological status, document the response to treatment, and calculate median survival of these patients.
- Perform an economic impact analysis comparing the two treatment arms.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
- Arm II: Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
Patients complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, at 5 weeks, and then every 3 months thereafter.
After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (control) | Active comparator | Radiation: radiation therapyPatients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy). |
| Arm II | Experimental | Radiation: radiation therapyPatients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| radiation therapyGiven in multiple fractions or as a single fraction | Radiation | Arm I (control), Arm II |
Primary outcome
Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
Time frame: 5 weeks from date of randomisation
5 secondary outcomes
Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire
Time frame: 5 weeks from date of randomisation
Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale
Time frame: 1 week after completion of therapy
Pain control: assessed using a Visual Analogue Scale
Time frame: Until death
Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause
Time frame: Until death
Sphincter function: assessed using an 'In-House' Bladder Function Scale
Time frame: Until death
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 31 Dec 2014.
- Derived from this study: PubMed 32157242Thirion PG, Dunne MT, Kelly PJ, Flavin A, O'Sullivan JM, Hacking D, Sasiadek W, Small C, Pomeroy MM, Martin J, McArdle O, Parker I, O'Sullivan LS, Shannon AM, Clayton-Lea A, Collins CD, Stevenson MR, Alvarez-Iglesias A, Armstrong JG, Moriarty M. Non-inferiority randomised phase 3 trial comparing two radiation schedules (single vs. five fractions) in malignant spinal cord compression. Br J Cancer. 2020 Apr;122(9):1315-1323. doi: 10.1038/s41416-020-0768-z. Epub 2020 Mar 11.
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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.
Pierre Thirion principal investigator
St Luke's Radiation Oncology Network
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation therapy in people with Spinal Cord Compression and Unspecified Adult Solid Tumor, Protocol Specific, run by Cancer Trials Ireland at 4 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ireland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale (time frame: 5 weeks from date of randomisation). 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 NCT00968643, 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 31 Dec 2014.