Vertebroplasty + SBRT for Spinal Cancer Pain Management

Recruiting at 3 trial locations

Overseen By Fidaa Al-Shakfa, M.sc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Pregnancy, Myeloma, Lymphoma, Plasmacytoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 month

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding vertebroplasty (a procedure where bone cement is injected to stabilize a spine fracture) to the usual stereotactic body radiation therapy (SBRT, a type of precise radiation treatment) can better manage pain and prevent fractures in people with spinal cancer. The researchers aim to determine if this combination can preserve spine stability and reduce pain more effectively than SBRT alone. Suitable candidates have cancer that has spread to the spine, experience significant pain, and are eligible for SBRT. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve future treatment options for spinal cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that vertebroplasty is generally well-tolerated and can help reduce pain for people with spinal tumors. This procedure is considered safe and has a good track record of improving the quality of life for patients with spinal issues.

Studies have found that Stereotactic Body Radiation Therapy (SBRT) is also a safe treatment for cancer that has spread to the spine. It effectively targets tumors while minimizing damage to nearby healthy tissues. Serious side effects are rare, though some patients might experience mild skin irritation.

Overall, both treatments are usually well-tolerated and have effectively managed pain in patients with spinal conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Vertebroplasty + SBRT approach because it combines two techniques to potentially enhance pain management in spinal cancer patients. Typically, Stereotactic Body Radiation Therapy (SBRT) is the go-to treatment, as it precisely targets cancerous cells with high-dose radiation. However, adding vertebroplasty, which involves stabilizing the spine with a special cement, might provide immediate pain relief and improve spine stability. This combination could offer a more comprehensive solution, addressing both pain and structural concerns, which isn't usually achieved with SBRT alone.

What evidence suggests that vertebroplasty combined with SBRT could be effective for spinal cancer pain management?

Research shows that stereotactic body radiation therapy (SBRT) effectively treats cancer that has spread to the spine. It relieves pain and controls tumor growth. Studies have demonstrated that SBRT can target cancer cells with strong radiation doses while protecting nearby healthy tissues. In this trial, one group of participants will receive SBRT alone, the standard of care. Another group will receive a combination of vertebroplasty and SBRT. Vertebroplasty stabilizes the spine, and when combined with SBRT, it may provide better and faster pain relief. This combination aims to enhance spine stability and reduce pain more effectively than SBRT alone. Early findings suggest this approach could lead to fewer spine fractures and improved quality of life for patients with spinal cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Véronique Freire, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for adults with cancer-related spinal pain, unstable spine lesions, and confirmed spinal metastases from T5 to L5. They must be able to handle radiation therapy, have a decent performance status (Karnofsky >60), and can't have more than 3 consecutive affected spine levels. Excluded are those with infections, MRI contraindications, prior treatments at the same site, large lesions or coagulation issues, severe neurological symptoms, certain cancer types like myeloma or lymphoma, pregnant/breastfeeding women or very short life expectancy.

Inclusion Criteria

My cancer diagnosis was confirmed through tissue examination.

Less than 3 consecutive levels reached

I can care for myself but may not be able to do active work.

Exclusion Criteria

Pregnancy or breastfeeding

Estimated survival of less than 6 months

I cannot or will not undergo SBRT treatment or vertebroplasty.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT) or SBRT alone

1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy
• Vertebroplasty

Trial Overview The study tests if adding vertebroplasty (a procedure that stabilizes the spine) before standard stereotactic body radiation therapy (SBRT) provides better early pain relief for patients with painful spinal bone metastases compared to SBRT alone.

How Is the Trial Designed?

Group I: V-SBRT Experimental Treatment 1 Intervention

Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)

Group II: SBRT Experimental Treatment 1 Intervention

SBRT is the actual standard of care.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

Cyberknife stereotactic ablative radiotherapy (SABR) demonstrated a 71.6% objective response rate in 53 patients with unresectable hepatocellular carcinoma (HCC), indicating its efficacy as a salvage treatment when other therapies failed.

The median survival time for patients treated with SABR was 20 months, with 1- and 2-year overall survival rates of 70.1% and 45.4%, respectively, suggesting that while SABR is effective, there is a need to address issues like out-field recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. Lo, CH., Huang, WY., Lee, MS., et al.[2022]

In a study of 85 patients with spine metastases treated with stereotactic ablative radiation therapy (SABR), the treatment demonstrated a 74.1% overall survival rate at two years and a 72.3% local control rate, indicating its efficacy in managing spinal metastases.

SABR was associated with significant pain relief, as 83.3% of patients with pre-treatment pain experienced a complete response, and the treatment showed a favorable safety profile with no severe toxicities reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for spinal metastases: experience at a single Brazilian institution. Marta, GN., de Arruda, FF., Miranda, FA., et al.[2023]

Stereotactic body radiation therapy (SBRT) provides better pain relief compared to external beam radiation therapy (EBRT) for patients with painful vertebral bone metastases, but it is more expensive, resulting in a cost-effectiveness ratio of $124,552 per quality-adjusted life year (QALY) gained.

SBRT may become cost-effective if patients have a median survival of 11 months or more, suggesting that it could be a better option for patients expected to live longer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of single fraction of stereotactic body radiation therapy compared with single fraction of external beam radiation therapy for palliation of vertebral bone metastases. Kim, H., Rajagopalan, MS., Beriwal, S., et al.[2022]

In a study of 93 patients with prostate cancer receiving stereotactic body radiotherapy (SBRT) for spinal metastases, local control rates were very high, with 99% at 1 year and 95% at 2 years for hormone-sensitive prostate cancer (HSPC), but lower for castrate-resistant prostate cancer (CRPC) at 94% and 78%, respectively.

The overall survival rates were significantly better for patients with HSPC, at 98% and 95% at 1 and 2 years, compared to 79% and 65% for those with CRPC, indicating that hormone sensitivity impacts both local control and survival outcomes after SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. Abugharib, A., Zeng, KL., Tseng, CL., et al.[2022]

In a study of 29 patients with spine metastases, combining single-fraction stereotactic ablative radiation therapy (SABR) with immediate prophylactic vertebroplasty resulted in a significant pain response improvement at 3 months (95% vs. 51% with conventional radiation therapy).

The treatment was well tolerated, with a 90% freedom from vertebral compression fractures (VCFs) at 1 year, indicating that this approach not only alleviates pain but also maintains structural stability in the spine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 2 Clinical Trial of SABR Followed by Immediate Vertebroplasty for Spine Metastases. Wardak, Z., Bland, R., Ahn, C., et al.[2019]

Stereotactic body radiotherapy (SBRT) using a regimen of 24 Gy in 2 fractions has shown high efficacy for treating spinal metastases, with 1-year local control rates between 83-93.9% and low rates of treatment-related complications, such as plexopathy and radiculopathy under 5%.

This SBRT regimen is not only effective for initial treatment but also feasible for reirradiation of previously treated spine metastases, maintaining local control rates of 72-86%, making it a strong option for patients with challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. Nguyen, EK., Ruschin, M., Zhang, B., et al.[2023]

In a study of 20 patients with spine bone metastases treated with stereotactic radio-therapy (SBRT), 74% experienced complete pain relief at three months, indicating a strong analgesic response.

The treatment was well-tolerated, with no severe toxicity (Grade 3 or higher) reported, suggesting that SBRT is a safe and effective option for pain management in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy (SBRT) for pain management in spine bone metastases]. Jara O, N., Solé P, C., Solé Z, S.[2020]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

Stereotactic body radiation therapy (SBRT) significantly reduces the risk of local failure and the need for reirradiation in patients with spinal metastases compared to conventional external beam radiation therapy (cEBRT), with local failure rates at 24 months being 14.8% for SBRT versus 35.6% for cEBRT (P < .001).

While SBRT has a lower reirradiation rate (2.2% at 1 year) compared to cEBRT (15.8% at 1 year), it is associated with a higher incidence of grade 3 vertebral compression fractures, indicating a need for careful monitoring of this adverse effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mature Local Control and Reirradiation Rates Comparing Spine Stereotactic Body Radiation Therapy With Conventional Palliative External Beam Radiation Therapy. Zeng, KL., Myrehaug, S., Soliman, H., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301619301531

A Phase 2 Clinical Trial of SABR Followed by Immediate ... This prospective clinical trial showed that the addition of prophylactic vertebroplasty with spine SABR can offer a significantly improved pain response.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5415159/

Spine Stereotactic Body Radiotherapy: Indications ... Spine SBRT is a highly effective treatment that is capable of delivering ablative doses to the target while sparing the critical organs-at-risk.

3. withpower.com withpower.com/trial/phase-spine-metastases-6-2022-728ac

Vertebroplasty + SBRT for Spinal Cancer Pain Management Research shows that stereotactic body radiation therapy (SBRT) is highly effective for treating spinal metastases, providing better pain relief and local ...

4. evtoday.com evtoday.com/articles/2020-oct/vertebral-augmentation-and-ablation-in-cancer-patients-with-spine-metastases

Vertebral Augmentation and Ablation in Cancer Patients ... On the other hand, the pain relief with ablation and vertebral augmentation is often much more rapid. Stereotactic radiation modalities are also associated with ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2788575

Predictive Score for Vertebral Compression Fracture After ... Stereotactic body radiation therapy is commonly used to manage spinal metastasis, with high rates of tumor control (80%-90%) and low rates of ...

6. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)89863-2/fulltext

Efficacy and safety of SBRT for spine metastases In this study, we summarize the available evidence for stereotactic body radiotherapy (SBRT) in the treatment of spinal metastases. Materials ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06078813

Spine SABR - Dose-escalated Stereotactic Ablative Body ... This study will look at treatment for patients that have already been diagnosed with cancer, but develop a new tumor(s) in the spine.

8. cancer.gov cancer.gov/news-events/cancer-currents-blog/2020/radiation-sbrt-painful-spinal-metastases

Radiation to Treat Painful Spinal Metastases - NCI A type of precise, high-dose radiation therapy may be a highly effective way to relieve that pain.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0167814023898085/pdf

Systematic Review Stereotactic body radiation therapy ... Adverse events were similar, except for any grade radiation dermatitis, which was significantly lower in SBRT arm (RR 0.17, 95% CI 0.03–0.96, P = 0.04).