Radiotherapy + Vertebroplasty for Spinal Metastases

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AHS Cancer Control Alberta

Disqualifiers: Primary bone tumors, Plasmacytoma, Cord compression, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1-3 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining vertebroplasty with radiotherapy can manage spinal metastases (cancer spread to the spine) more effectively than radiotherapy alone. Radiotherapy controls tumors but does not prevent fractures well, while vertebroplasty strengthens the spine and eases pain. By combining the two, researchers hope to relieve pain, stabilize the spine, and reduce the need for painkillers. The trial seeks participants with confirmed spinal metastases who experience significant pain in their thoracic or lumbar spine. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research shows that vertebroplasty is generally safe for patients with cancer that has spread to the spine. Studies have found that it can quickly ease pain and improve mobility. This procedure benefits those with spinal tumors by enhancing their quality of life. One study even noted a lower death rate for patients who received vertebral augmentation, including vertebroplasty.

Radiotherapy is a well-known treatment for cancer that has spread to the bones. While it effectively controls tumors in the area, it doesn't strengthen the spine or prevent fractures in weakened bones. Combining vertebroplasty with radiotherapy might provide better pain relief and spine support.

Overall, both vertebroplasty and radiotherapy are generally well-tolerated. Serious side effects are rare, but they can occur. Discussing potential risks and benefits with healthcare providers is important before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining vertebroplasty with radiotherapy for treating spinal metastases because this approach offers a unique blend of structural support and cancer control. Vertebroplasty stabilizes weakened bones by injecting a special cement into the spine, which can quickly relieve pain and prevent fractures. This is then followed by radiotherapy, which targets and shrinks cancer cells. While traditional treatments often focus on either pain management or tumor reduction separately, this combination aims to achieve both simultaneously, potentially improving quality of life more efficiently for patients.

What evidence suggests that combining vertebroplasty with radiotherapy could be effective for spinal metastases?

Research has shown that combining vertebroplasty with radiotherapy effectively relieves pain and improves daily life for patients with cancer that has spread to the spine. In this trial, one group of participants will receive vertebroplasty followed by radiotherapy, while another group will receive only radiotherapy. Studies indicate that vertebroplasty alone can relieve pain in up to 94% of patients, demonstrating a high success rate. While radiotherapy helps control the spread of cancer in the bones, it does not strengthen the spine or prevent fractures. Vertebroplasty, however, quickly reduces pain and improves function, making it a valuable addition to radiotherapy. Together, they are believed to stabilize the spine, relieve pain, and possibly reduce the need for pain medications. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with painful spinal metastases confirmed by imaging, who can perform daily activities (ECOG score 0-2 or Karnofsky ≥60%), and have a life expectancy over 6 months. It's not for those with certain conditions like plasmacytoma, prior radiotherapy in the same spine region, or spinal cord compression. Participants must be able to follow the study plan and use effective birth control if of childbearing potential.

Inclusion Criteria

I have painful spine cancer in my mid or lower back.

My cancer has spread to the bones in my spine, confirmed by scans.

I can take care of myself and perform daily activities.

Exclusion Criteria

Doctors believe you may have less than 6 months to live based on your health condition and a special calculation called the Linden model.

You have a broken bone that has been diagnosed by a doctor.

I have been diagnosed with a plasmacytoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either radiotherapy alone or vertebroplasty followed by radiotherapy

1-3 weeks

1-5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at 1, 3, 6, and 12 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Radiotherapy
• Vertebroplasty

Trial Overview The trial tests combining vertebroplasty (a procedure that stabilizes the spine) with radiotherapy against radiotherapy alone in patients with spinal metastases. The goal is to see if this combination provides better pain relief, prevents vertebral fractures, and reduces opioid need compared to just using radiotherapy.

How Is the Trial Designed?

Group I: Vertebroplasty + Radiotherapy Experimental Treatment 2 Interventions

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)

Group II: Radiotherapy Active Control 1 Intervention

Radiotherapy dose: 20 Gy/5 fractions/1 week or 8 Gy/1 fraction (at the discretion of the Radiation Oncologist)

Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in United States as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Canada as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Japan as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in China as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Switzerland as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Cross Cancer Institute

Collaborator

Trials

62

Recruited

19,200+

Published Research Related to This Trial

The combination of intraoperative radiotherapy (IORT) and kyphoplasty provides a new treatment option for symptomatic vertebral metastases, specifically between vertebrae T3 and L5, enhancing the effectiveness of traditional methods.

This procedure involves administering an 8 Gy radiation dose during surgery, followed by kyphoplasty to stabilize the vertebra, potentially improving patient outcomes compared to existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Kyphoplasty in combination with intraoperative radiotherapy. Technical and regulatory characteristics of a concept for treatment of vertebral metastases]. Kayser, R., Ender, SA., Asse, E., et al.[2022]

In a study of 78 patients with asymptomatic high-risk bone metastases, prophylactic radiation therapy significantly reduced the occurrence of skeletal-related events (SRE) to just 1.6% compared to 29% in the standard of care group, indicating its efficacy in preventing complications.

Patients receiving radiation therapy also experienced fewer hospitalizations for SRE and had a longer overall survival rate, with a hazard ratio of 0.49, suggesting that this treatment may improve patient outcomes in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic Radiation Therapy Versus Standard of Care for Patients With High-Risk Asymptomatic Bone Metastases: A Multicenter, Randomized Phase II Clinical Trial. Gillespie, EF., Yang, JC., Mathis, NJ., et al.[2023]

Vertebroplasty is an effective adjuvant therapy for patients with metastatic spinal disease, providing additional stabilization and pain relief when used alongside radiotherapy and surgical management.

Case studies indicate that incorporating vertebroplasty into treatment plans can enhance patient outcomes, particularly in terms of vertebral stability and pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of vertebroplasty in metastatic spinal disease. Pilitsis, JG., Rengachary, SS.[2022]

A combined treatment approach of ablation, vertebroplasty, and radiotherapy for bone metastasis in the spine showed promising results in 12 lesions across 11 patients, with follow-up ranging from 6 to 48 months.

Patients experienced rapid and lasting relief from symptoms, with disease stability in the treated bone segments, suggesting that this method could be a viable curative option for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ablation, consolidation and radiotherapy for the management of metastatic lesions of the spine: impact on the quality of life in a mid-term clinical and diagnostic follow-up in a pilot study. Arrigoni, F., de Cataldo, C., Bruno, F., et al.[2020]

External beam radiotherapy effectively manages pain from bone metastases, including cases of spinal canal compression and pathological fractures, potentially preventing further complications.

Single-dose radiotherapy is a highly cost-effective palliative treatment option for patients with bone metastases, making it a practical choice for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of external beam radiotherapy in the management of bone metastases. Agarawal, JP., Swangsilpa, T., van der Linden, Y., et al.[2022]

Analgesic external beam radiation therapy is an effective standard treatment for managing pain from bone metastases and is crucial for preventing complications, especially after surgeries like vertebroplasty or kyphoplasty.

Advanced techniques like intensity-modulated radiotherapy and stereotactic radiotherapy may offer curative options for patients with oligometastatic disease, expanding treatment possibilities beyond just pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Conformal radiotherapy for vertebral bone metastasis]. Faivre, JC., Py, JF., Vogin, G., et al.[2017]

External beam radiation therapy is an effective treatment for relieving pain caused by bone metastases, and it is widely prescribed around the world.

Despite existing recommendations for palliative irradiation of bone metastases, there is still significant variability in how these practices are implemented internationally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bone metastases radiotherapy: Multi-approaches literature review]. Le Fèvre, C., Antoni, D., Thiéry, A., et al.[2018]

External beam radiation therapy (EBRT) is an effective and time-efficient treatment for managing painful bone metastases, and it should be included in the multidisciplinary care of most patients with this condition.

Recent treatment guidelines have clarified the appropriate use of EBRT in the management of bone metastases, helping to standardize care and improve quality measures in radiotherapy departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of radiation therapy in controlling painful bone metastases. Lutz, S.[2021]

Approximately 70% of patients with bone metastases experience pain relief from palliative external beam radiotherapy, with some noticing improvement within 48 to 72 hours, although others may take up to 4 weeks for significant relief.

Treatment plans should be personalized based on individual patient factors, and external beam radiotherapy is particularly beneficial after surgeries for fractures to enhance recovery and reduce the need for additional surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General principles of external beam radiation therapy for skeletal metastases. Frassica, DA.[2018]

Spinal stereotactic body radiotherapy (SBRT) shows promising efficacy for patients with spinal metastases who have previously undergone conventional external beam radiation therapy (cEBRT), with a low local failure rate of 18% and actuarial rates of 7%, 14%, and 19% at 6, 12, and 24 months, respectively.

The treatment is considered safe, with a low risk of vertebral compression fractures (4%) and no observed cases of radiation myelopathy, making it a viable option for patients with extensive prior radiation history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mature Imaging-Based Outcomes Supporting Local Control for Complex Reirradiation Salvage Spine Stereotactic Body Radiotherapy. Detsky, JS., Nguyen, TK., Lee, Y., et al.[2021]

The combination of percutaneous vertebroplasty and stereotactic radiosurgery (SRS) offers early pain relief and effective tumor control for patients with spinal metastasis, avoiding the need for more invasive surgical procedures.

This treatment approach is particularly beneficial for patients without significant spinal instability or canal compromise, as it reduces morbidity and enhances the ability to start systemic cancer therapies sooner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of C2 vertebroplasty and stereotactic radiosurgery for treatment of lytic metastasis of the odontoid process. Hribar, CA., Bhowmick, DA.[2020]

Recent advancements in radiology and radiation oncology have significantly improved the ability to target and treat vertebral metastases, leading to better palliative relief and local control of spinal tumors.

Despite these improvements, radiation therapy can still cause various acute and delayed complications, such as pain flare and radiation myelopathy, highlighting the need for careful treatment planning and multidisciplinary collaboration to manage these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fundamentals of Radiation Oncology for Treatment of Vertebral Metastases. Gottumukkala, S., Srivastava, U., Brocklehurst, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5510125/

Effectiveness and safety of percutaneous vertebroplasty in ... Conclusion: Percutaneous vertebroplasty can relieve pain efficiently, improve the daily living ability, and significantly enhance the living quality of patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10811784/

A retrospective cohort study on the efficacy and safety of ... For spinal metastases with posterior wall defect, PVP combined with BFMCs was highly safe and can effectively relieve pain for patients.

3. ajronline.org ajronline.org/doi/10.2214/AJR.12.10497

Safety and Efficacy of Percutaneous Vertebroplasty and ... Our results of 94% pain relief or pain relief during follow-up were at the higher end of the reported range of 73–100% pain relief in patients with spinal ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0011384025001042

Clinical effectiveness of percutaneous vertebroplasty in ... The vertebroplasty group reported greater satisfaction with treatment, suggesting the procedure met expectations and improved overall well-being in patients.

5. cms.gov cms.gov/medicare-coverage-database/view/technology-assessments.aspx?taid=26&year=0&sortBy=title&bc=19

TA - Percutaneous Vertebroplasty For Vertebral Fractures ... Two studies showed significant decreases in analgesic use, and 4 studies showed improvements in either physical function or disability scale scores. One study ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0960977622000704

The role of percutaneous vertebral augmentation in ... These studies reported that PVP and PKP are both safe and effective in providing pain relief with spinal metastases [[43], [44], [45], [46], [47]]. For example, ...

7. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2020191294

Mortality Outcomes of Vertebral Augmentation ... In this meta-analysis, vertebral augmentation (with either vertebroplasty and/or balloon kyphoplasty) provided a 22% reduction in mortality ...