Spinal MetastasesPhase 2NCT01290562
Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases (Spine SBRT)
A Phase 2 study testing Stereotactic Body Radiotherapy (SBRT) in people with Spinal Metastases, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Patients with new or recurrent spine metastases are currently treated with low doses of radiation delivered in up to ten treatments (wide-field radiation therapy). Stererotactic body radiotherapy (SBRT) is a technique in which high doses of radiation targeted precisely to the metastases to be treated are administered… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to 27 Apr 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solitary or oligometastatic spine disease (maximum 5 sites of metastases), or bone only metastatic disease (regardless of the number) in otherwise high performance status patients, or patients with diffuse metastatic disease where the patient survival is expected to be at least 6 months
- Maximum of 2 consecutive spinal segments involved by tumor for treatment otherwise a maximum of 3 sites within the spine to be treated in a single session
- Previously irradiated: up to one course where the maximum BED previously delivered is no more than 100 Gy2 (50 Gy2/2) and >5 month interval from prior radiation to planned SBRT (Cohort 2) or first part of cohort 3
- Karnofsky Performance Status >60
- Had an MRI or CT documented spinal tumor and MRI of full spine no more than 8 weeks prior to SBRT (if patients cannot have a MRI then a CT myelogram is required)
- Had a histological confirmation of neoplastic disease
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- Expected to have survival of > 3 months regardless of the number of metastases
- Able to lie still and in a supine position on the treatment couch for up to 1 hour
- Age >18
- Adequate Bowel or urinary function
Who cannot join
- A Pacemaker such that MRI cannot be performed or the treatment cannot be delivered safely
- Scleroderma or connective tissue disease as a contra-indication to radiotherapy
- Unable to lie supine (i.e. tolerate treatment)
- Previously treated with any radionuclides within 30 days prior to SBRT
- Had external beam radiotherapy to the same area less than 5 months prior to SBRT and/or a course of radiation previously delivered >100 Gy2 (50 Gy2/2)
- Significant or progressive neurologic deficit
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- Malignant epidural spinal cord compression or cauda equina syndrome
- Spine instability, or neurological deficit resulting from bony compression of neural structures
- Receiving chemotherapy for at least 1 week prior to SBRT and chemotherapy for one week following SBRT
- Expected patient survival < 3 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A University of Toronto Phase II Study to Determine Efficacy of Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases
Patients with new or recurrent spine metastases are currently treated with low doses of radiation delivered in up to ten treatments (wide-field radiation therapy). Stererotactic body radiotherapy (SBRT) is a technique in which high doses of radiation targeted precisely to the metastases to be treated are administered in a small number of sessions, thus reducing the radiation damage to the surrounding tissue and areas of the spine.
The purpose of this study is to evaluate the efficacy of spine SBRT as an alternative to conventional radiation for patients with no prior radiation, prior radiation, and in the post-operative patient
Read the detailed description
Spine SBRT is currently being practiced as an alternative to conventional wide-field radiation in the up-front management of spinal metastases, in the re-irradiation scenario, and in the post-operative setting. This study proposes to treat patients with a uniform spine SBRT approach, and collect prospective outcome data as a basis for future randomized trial design. Preliminary evaluation of our technique has yielded acceptable accuracy in treatment delivery as compared to the literature, and our practice follows current standards in major university hospitals performing this technique. Furthermore, preliminary data also suggest efficacy and safety for patients treated with SBRT for spinal metastases in a previously radiated field. However, well defined prospective outcomes are lacking in this patient group.
There a 3 cohorts for this study each with a target accrual of 30 patients. Cohort 1: patients with spinal metastases and no prior radiation.
Cohort 2: patients with spinal metastases with a history of previous radiation to the affected spinal segment.
Cohort 3: post-operative patients with spinal metastases with or without a history of previous radiation to the affected spinal segment.
All patients will be treated with either 20-24 Gy in one fraction (recommended) or 20-24 Gy in two fractions, or 20-24 Gy in three fractions. There is also and optional imaging component of this study.
The purpose of the study is to determine the efficacy of spine SBRT in select groups of patients using image based and symptom based local control criteria
- Conditions
- Spinal Metastases
- Being tested
- Stereotactic Body Radiotherapy (SBRT)
- Keywords
- SBRT, spinal Metastases, Paraspinal Metastases, spinal Metastases and SBRT, Paraspinal Metastases and SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy (SBRT)Radiation
One or more high dose(s) of radiation to treat the tumour.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | Cohort 1: Patients with spinal metastases and no prior radiation Cohort 2: Patients with spinal metastases in a previously radiated field Cohort 3: Post-operative patients with spinal metastases Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of spine SBRT in select groups of patients using image based and symptom based local control criteria
Measured: 5 years
Secondary outcomes (5)
To determine prospective pain and functional outcome data using the Brief Pain Inventory questionnaire
Measured: 5 years
To prospectively document quality of life outcomes for patients post-SBRT using the validated EORTC QLQ - BM22 and C-15 PAL
Measured: 5 years
To determine pain flare prospective data by using the Pain Diary for first 10 days after radiation.
Measured: 5 years
To prospectively evaluate neurologic outcomes using the ASIA questionnaire
Measured: 5 years
To evaluate acute and late toxicity of RT using NCIC Common Toxicity Criteria v. 3.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2015
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Cho, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290562
- Sponsor's protocol ID
- UHN REB 10-0540-C
- Status last verified
- May 2017
- First submitted
- 3 Feb 2011
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A University of Toronto Phase II Study to Determine Efficacy of Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases
- ClinicalTrials.gov ID
- NCT01290562
- Acronym / sponsor ID
- UHN REB 10-0540-C
- Conditions
- Spinal Metastases
- Keywords
- SBRT, spinal Metastases, Paraspinal Metastases, spinal Metastases and SBRT, Paraspinal Metastases and SBRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 7 Feb 2011 (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.
Patients with new or recurrent spine metastases are currently treated with low doses of radiation delivered in up to ten treatments (wide-field radiation therapy). Stererotactic body radiotherapy (SBRT) is a technique in which high doses of radiation targeted precisely to the metastases to be treated are administered in a small number of sessions, thus reducing the radiation damage to the surrounding tissue and areas of the spine.
The purpose of this study is to evaluate the efficacy of spine SBRT as an alternative to conventional radiation for patients with no prior radiation, prior radiation, and in the post-operative patient
Detailed description
Spine SBRT is currently being practiced as an alternative to conventional wide-field radiation in the up-front management of spinal metastases, in the re-irradiation scenario, and in the post-operative setting. This study proposes to treat patients with a uniform spine SBRT approach, and collect prospective outcome data as a basis for future randomized trial design. Preliminary evaluation of our technique has yielded acceptable accuracy in treatment delivery as compared to the literature, and our practice follows current standards in major university hospitals performing this technique. Furthermore, preliminary data also suggest efficacy and safety for patients treated with SBRT for spinal metastases in a previously radiated field. However, well defined prospective outcomes are lacking in this patient group.
There a 3 cohorts for this study each with a target accrual of 30 patients. Cohort 1: patients with spinal metastases and no prior radiation.
Cohort 2: patients with spinal metastases with a history of previous radiation to the affected spinal segment.
Cohort 3: post-operative patients with spinal metastases with or without a history of previous radiation to the affected spinal segment.
All patients will be treated with either 20-24 Gy in one fraction (recommended) or 20-24 Gy in two fractions, or 20-24 Gy in three fractions. There is also and optional imaging component of this study.
The purpose of the study is to determine the efficacy of spine SBRT in select groups of patients using image based and symptom based local control criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT)Cohort 1: Patients with spinal metastases and no prior radiation Cohort 2: Patients with spinal metastases in a previously radiated field Cohort 3: Post-operative patients with spinal metastases |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Solitary or oligometastatic spine disease (maximum 5 sites of metastases), or bone only metastatic disease (regardless of the number) in otherwise high performance status patients, or patients with diffuse metastatic disease where the patient survival is expected to be at least 6 months
- Maximum of 2 consecutive spinal segments involved by tumor for treatment otherwise a maximum of 3 sites within the spine to be treated in a single session
- Previously irradiated: up to one course where the maximum BED previously delivered is no more than 100 Gy2 (50 Gy2/2) and >5 month interval from prior radiation to planned SBRT (Cohort 2) or first part of cohort 3
- Karnofsky Performance Status >60
- Had an MRI or CT documented spinal tumor and MRI of full spine no more than 8 weeks prior to SBRT (if patients cannot have a MRI then a CT myelogram is required)
Key exclusion criteria (10 listed)
- A Pacemaker such that MRI cannot be performed or the treatment cannot be delivered safely
- Scleroderma or connective tissue disease as a contra-indication to radiotherapy
- Unable to lie supine (i.e. tolerate treatment)
- Previously treated with any radionuclides within 30 days prior to SBRT
- Had external beam radiotherapy to the same area less than 5 months prior to SBRT and/or a course of radiation previously delivered >100 Gy2 (50 Gy2/2)
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 |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT)One or more high dose(s) of radiation to treat the tumour. | Radiation | Stereotactic Body Radiotherapy (SBRT) |
Primary outcome
To determine the efficacy of spine SBRT in select groups of patients using image based and symptom based local control criteria
Time frame: 5 years
5 secondary outcomes
To determine prospective pain and functional outcome data using the Brief Pain Inventory questionnaire
Time frame: 5 years
To prospectively document quality of life outcomes for patients post-SBRT using the validated EORTC QLQ - BM22 and C-15 PAL
Time frame: 5 years
To determine pain flare prospective data by using the Pain Diary for first 10 days after radiation.
Time frame: 5 years
To prospectively evaluate neurologic outcomes using the ASIA questionnaire
Time frame: 5 years
To evaluate acute and late toxicity of RT using NCIC Common Toxicity Criteria v. 3.0
Time frame: 5 years
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 3 May 2017.
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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.
John Cho, MD principal investigator
University Health Network, Princess Margaret Hospital
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 Stereotactic Body Radiotherapy (SBRT) in people with Spinal Metastases, run by University Health Network, Toronto at 1 site in Canada.
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 10 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 3 May 2017. 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 Canada. 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?
To determine the efficacy of spine SBRT in select groups of patients using image based and symptom based local control criteria (time frame: 5 years). 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 3 May 2017.