Spinal MetastasesPhase 2NCT04242589
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
A Phase 2 study testing Radiotherapy and Vertebropladty in people with Spinal Metastases, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Since patients with spinal metastases are living longer, durable palliation with long-term tumor control are becoming increasingly important. EBRT results in durable local control of bone metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- Radiotherapy and Vertebropladty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 3 Mar 2021to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
- Patients must be 18 years of age or older
- Spinal vertebral metastases confirmed by CT, MRI or bone scan.
- Patients with painful (VAS of at least ≥ 2) vertebral spinal metastases in the thoracic and /or lumbar spine (not cervical).
- Patients must be willing and able to comply with schedule visits, treatment plan, tests and other study procedures
- Life expectancy > 6 months. Life expectancy will be evaluated by the study investigator both clinically and by using Linden model. Patient should be in the group B or C of the Linden model.
Show all 13Show fewer
- Patients with an ECOG score 0-2 or Karnofsky performance status of ≥ 60% will be eligible for enrolment (see appendix 1).
- No prior EBRT to the target +/-1 vertebral body level
- Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause
- Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard) .
- Females must not breastfeed during study treatment.
- Male patients should agree to not donate sperm during study treatment.
- Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration
Who cannot join
- Patient cannot provide consent
- Prior radiotherapy to the target +/-1 vertebral body level
- Life expectancy < 6 months (assessed both clinically and using Linden model)
- Karnofsky performance status of < 60%
- Primary bone tumors
- Plasmacytoma
Show all 9Show fewer
- Communicated fracture
- Associated Impending cord compression or spinal cord compression
- Epidural involvement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized Trial of Combined Radiotherapy and Vertebroplasty to Improve the Quality of Life of Patients With Painful Metastatic Localized Spinal Lesions
Since patients with spinal metastases are living longer, durable palliation with long-term tumor control are becoming increasingly important.
EBRT results in durable local control of bone metastasis. However, about 25 % of patients with spinal metastases only achieved complete pain relief following EBRT for a median duration of less than 4 months. This could be partly due to spinal instability. In addition, almost half of the patients who receive EBRT will subsequently develop VCFs . Hence, RT does not stabilize the spine secondary to VCFs and is not effective in preventing imminent VCFs. Vertebroplasty has rapidly reduced pain and improved function in patients with VCFs. However, vertebroplasty does not provide local tumor control similar to EBRT.
It is theorized that combining vertebroplasty with EBRT will stabilize the spine, relieve the pain, prevent imminent VCFs and minimize or avoid the need for opioids. It is hypothesized that combining a spine stabilization procedure such as vertebroplasty with RT will be the most effective management for patients with spinal metastases than RT alone for patients with spinal metastases. Combined vertebroplasty and radiotherapy is not a standard treatment option at present. This study is designed to quantify the advantage of adding vertebroplasty to radiotherapy for patients with spinal metastases. If the study is proven to be significant, it could become the standard of care for patients with spinal metastases.
- Conditions
- Spinal Metastases
- Being tested
- Radiotherapy, Vertebropladty
- Keywords
- Vertebroplasty, Vertebral Compression Fracture, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called External Beam Radiation Therapy
External beam radiation therapy is a type of radiation therapy used for cancer treatment. A machine is used to aim high-energy rays from outside the body into tumor
VertebropladtyProcedure or surgery
Vertebroplasty is a procedure for stabilizing compression fractures in the spine. Bone cement is injected into vertebrae that have cracked or broken. The cement hardens, stabilizing the fractures and supporting your spine.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Active comparator | Radiotherapy dose: 20 Gy/5 fractions/1 week or 8 Gy/1 fraction (at the discretion of the Radiation Oncologist) Receives: Radiation: Radiotherapy |
| Vertebroplasty + Radiotherapy | Experimental | Vertebroplasty followed by radiotherapy within 2-3 weeks
Radiotherapy dose: 20 Gy/5 fractions/1 week or 8 Gy/1 fraction (at the discretion of the Radiation Oncologist) Receives: Radiation: Radiotherapy; Procedure: Vertebropladty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Pain Score based on the Visual Analog Scale
The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the visual analogue Scale (VAS) without concurrent increase in opioids.
Measured: 1,3,6 and 12 months post treatment
Improvement in Pain Score based on the Brief Pain Inventory
The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the Brief Pain Inventory (BPI) without concurrent increase in opioids.
Measured: 1,3,6 and 12 months post treatment
Secondary outcomes (4)
Changes in back-specific physical functioning
The improvement in back-specific physical functioning is evaluated by the change in Roland-Morris disability questionnaire (RDQ) score.
Measured: 1,3,6 and 12 months post treatment
Incidence of vertebral compression fractures post treatment.
The incidence of vertebral compression fractures will be evaluated by standing lateral spine radiographs of the thoracic and lumbar vertebrae.
Measured: Baseline, 6 months and 12 months
Prospectively quantify pain response using the Visual Analog Scale
Pain response will be assessed by VAS and evaluated using a patient diary based on the International Bone Metastases Working Party Criteria. Based on intake of analgesics, the daily oral morphine equivalent dose (OMED) will be calculated.
Measured: 1,3,6 and 12 months post treatment
Prospectively quantify pain response using the Brief Pain Inventory.
Pain response will be assessed by BPI and evaluated using a patient diary based on the International Bone Metastases Working Party Criteria. Based on intake of analgesics, the daily oral morphine equivalent dose (OMED) will be calculated.
Measured: 1,3,6 and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start3 Mar 2021
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242589
- Sponsor's protocol ID
- IIT-0008
- Status last verified
- Nov 2026
- First submitted
- 21 Jan 2020
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of Combined Radiotherapy and Vertebroplasty to Improve the Quality of Life of Patients With Painful Metastatic Localized Spinal Lesions
- ClinicalTrials.gov ID
- NCT04242589
- Acronym / sponsor ID
- IIT-0008
- Conditions
- Spinal Metastases
- Keywords
- Vertebroplasty, Vertebral Compression Fracture, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 Jan 2020 (actual)
- 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.
Since patients with spinal metastases are living longer, durable palliation with long-term tumor control are becoming increasingly important.
EBRT results in durable local control of bone metastasis. However, about 25 % of patients with spinal metastases only achieved complete pain relief following EBRT for a median duration of less than 4 months. This could be partly due to spinal instability. In addition, almost half of the patients who receive EBRT will subsequently develop VCFs . Hence, RT does not stabilize the spine secondary to VCFs and is not effective in preventing imminent VCFs. Vertebroplasty has rapidly reduced pain and improved function in patients with VCFs. However, vertebroplasty does not provide local tumor control similar to EBRT.
It is theorized that combining vertebroplasty with EBRT will stabilize the spine, relieve the pain, prevent imminent VCFs and minimize or avoid the need for opioids. It is hypothesized that combining a spine stabilization procedure such as vertebroplasty with RT will be the most effective management for patients with spinal metastases than RT alone for patients with spinal metastases. Combined vertebroplasty and radiotherapy is not a standard treatment option at present. This study is designed to quantify the advantage of adding vertebroplasty to radiotherapy for patients with spinal metastases. If the study is proven to be significant, it could become the standard of care for patients with spinal metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Active comparator | Radiation: RadiotherapyRadiotherapy dose: 20 Gy/5 fractions/1 week or 8 Gy/1 fraction (at the discretion of the Radiation Oncologist) |
| Vertebroplasty + Radiotherapy | Experimental | Radiation: Radiotherapy, Procedure: VertebropladtyVertebroplasty followed by radiotherapy within 2-3 weeks Radiotherapy dose: 20 Gy/5 fractions/1 week or 8 Gy/1 fraction (at the discretion of the Radiation Oncologist) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
- Patients must be 18 years of age or older
- Spinal vertebral metastases confirmed by CT, MRI or bone scan.
- Patients with painful (VAS of at least ≥ 2) vertebral spinal metastases in the thoracic and /or lumbar spine (not cervical).
- Patients must be willing and able to comply with schedule visits, treatment plan, tests and other study procedures
Key exclusion criteria (9 listed)
- Patient cannot provide consent
- Prior radiotherapy to the target +/-1 vertebral body level
- Life expectancy < 6 months (assessed both clinically and using Linden model)
- Karnofsky performance status of < 60%
- Primary bone tumors
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 |
|---|---|---|
| RadiotherapyAlso: External Beam Radiation TherapyExternal beam radiation therapy is a type of radiation therapy used for cancer treatment. A machine is used to aim high-energy rays from outside the body into tumor | Radiation | Radiotherapy, Vertebroplasty + Radiotherapy |
| VertebropladtyVertebroplasty is a procedure for stabilizing compression fractures in the spine. Bone cement is injected into vertebrae that have cracked or broken. The cement hardens, stabilizing the fractures and supporting your spine. | Procedure or surgery | Vertebroplasty + Radiotherapy |
Primary outcome
Improvement in Pain Score based on the Visual Analog Scale
Time frame: 1,3,6 and 12 months post treatment
The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the visual analogue Scale (VAS) without concurrent increase in opioids.
Improvement in Pain Score based on the Brief Pain Inventory
Time frame: 1,3,6 and 12 months post treatment
The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the Brief Pain Inventory (BPI) without concurrent increase in opioids.
4 secondary outcomes
Changes in back-specific physical functioning
Time frame: 1,3,6 and 12 months post treatment
Incidence of vertebral compression fractures post treatment.
Time frame: Baseline, 6 months and 12 months
Prospectively quantify pain response using the Visual Analog Scale
Time frame: 1,3,6 and 12 months post treatment
Prospectively quantify pain response using the Brief Pain Inventory.
Time frame: 1,3,6 and 12 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Related trials for Spinal Metastases
Active, not recruitingPhase 2
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
Spinal Metastases
RecruitingObservational study
Spine Oncology Registry
Spine Tumor, Spine Metastases
RecruitingPhase 2
Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease
Chest Wall Tumor, Breast Cancer
Recruiting
The Effect of Radiotherapy After Separation Surgery for Spinal Metastases
Spinal Metastases, Spinal Tumor
Recruiting
Efficacy and Safety of Stereotactic Body Radiation Therapy for Spinal Metastases With Bilsky Grade 1c-3
Stereotactic Body Radiation Therapy (SBRT), Spinal Metastases
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Radiotherapy and Vertebropladty in people with Spinal Metastases, run by AHS Cancer Control Alberta 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 13 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Improvement in Pain Score based on the Visual Analog Scale (time frame: 1,3,6 and 12 months post treatment). 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?
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 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.