Spinal Cord CompressionNCT00727584
Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression
A study testing radiation therapy in people with Spinal Cord Compression and Unspecified Adult Solid Tumor, Protocol Specific, run by Cancer Research UK at 4 sites in United Kingdom.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic 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
- 100 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Nov 2007to Aug 2009
- Phase
- Interventional
- 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 or cytologically confirmed malignant disease
- Proven diagnosis of metastatic spinal cord compression on MRI or CT scan
- Single site of compression OR multiple sites that can be treated within a single radiation treatment field
- No patient for whom surgery or chemotherapy treatment is more appropriate
- No multiple myeloma as primary cancer
PATIENT CHARACTERISTICS:
- Life expectancy > 1 month
- Not pregnant
- Willing and able to complete assessment forms
- Able to give informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Christie Hospital
Manchester, M20 6UX
Cancer Research UK and University College London Cancer Trials Centre
Northwood, England, HA6 2RN
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
About this study
Official title: SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression.
PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.
Read the detailed description
OBJECTIVES:
- To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression.
- To determine the feasibility of conducting this study in the United Kingdom.
OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease [spinal metastases only vs spinal and non-bony metastases]). Patients are randomized to 1 of 2 treatment arms.
- Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
- Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.
- 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
Patients undergo external beam radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (multi-fraction radiotherapy) | Active comparator | Patients undergo 5 fractions of 20 Gy external-beam radiotherapy. Receives: Radiation: radiation therapy |
| Arm II (single-fraction radiotherapy) | Experimental | Patients undergo 1 fraction of 8 Gy external beam radiotherapy. Receives: Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient accrual per center over a 12-month period
Secondary outcomes (9)
Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
Quality of life as measured by the EORTC QLQ-C30 questionnaire at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Further treatment
Overall survival at 3, 6, and 12 months
Total number of days spent in hospital
Preferred place of care
Number of patients eligible but not randomized and reasons for non-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionFeb 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Peter J. Hoskin, MD, Principal investigator, Mount Vernon Cancer Centre at Mount Vernon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727584
- Sponsor's protocol ID
- CDR0000599886
- Other IDs
- CRUK-UCL-BRD-07-010, CRUK-SCORAD, ISRCTN97555949, EU-20863
- Status last verified
- Jun 2009
- First submitted
- 1 Aug 2008
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
- ClinicalTrials.gov ID
- NCT00727584
- Acronym / sponsor ID
- CDR0000599886
- Keywords
- spinal cord compression, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Aug 2008 (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 regimen is more effective in treating metastatic spinal cord compression.
PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.
Detailed description
OBJECTIVES:
- To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression.
- To determine the feasibility of conducting this study in the United Kingdom.
OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease [spinal metastases only vs spinal and non-bony metastases]). Patients are randomized to 1 of 2 treatment arms.
- Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
- Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (multi-fraction radiotherapy) | Active comparator | Radiation: radiation therapyPatients undergo 5 fractions of 20 Gy external-beam radiotherapy. |
| Arm II (single-fraction radiotherapy) | Experimental | Radiation: radiation therapyPatients undergo 1 fraction of 8 Gy external beam radiotherapy. |
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 therapyPatients undergo external beam radiotherapy | Radiation | Arm I (multi-fraction radiotherapy), Arm II (single-fraction radiotherapy) |
Primary outcome
Patient accrual per center over a 12-month period
9 secondary outcomes
Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
Quality of life as measured by the EORTC QLQ-C30 questionnaire at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Further treatment
Overall survival at 3, 6, and 12 months
Total number of days spent in hospital
Preferred place of care
Number of patients eligible but not randomized and reasons for non-randomization
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 26 Aug 2013.
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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 J. Hoskin, MD principal investigator
Mount Vernon Cancer Centre at Mount Vernon Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiation therapy in people with Spinal Cord Compression and Unspecified Adult Solid Tumor, Protocol Specific, run by Cancer Research UK at 4 sites in United Kingdom.
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 26 Aug 2013. 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 United Kingdom. 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.
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?
Patient accrual per center over a 12-month period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2013.