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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Radiotherapy + Vertebroplasty for Spinal Metastases?

External beam radiotherapy is effective in managing bone metastases, providing pain relief and improving function, and is often used alongside other treatments like vertebroplasty. Vertebroplasty, a procedure to stabilize spinal bones, is commonly used with radiotherapy to enhance treatment outcomes for spinal metastases. ^{1 2 3 4 5}

Is the combination of radiotherapy and vertebroplasty safe for treating spinal metastases?

Radiotherapy and vertebroplasty are generally considered safe for treating spinal metastases, but they can have side effects. Radiotherapy may cause pain flare, skin irritation, and rare complications like vertebral fractures or nerve damage. Vertebroplasty provides pain relief and stabilization, but its safety is supported by case studies. ^{3 6 7 8 9}

How is the treatment of radiotherapy combined with vertebroplasty unique for spinal metastases?

This treatment is unique because it combines radiotherapy, which helps reduce pain and control tumor growth, with vertebroplasty, which stabilizes the spine and provides additional pain relief. This combination offers a more comprehensive approach by addressing both the tumor and the structural integrity of the spine, potentially improving quality of life and reducing recovery time compared to surgery. ^{3 6 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Mature Imaging-Based Outcomes Supporting Local Control for Complex Reirradiation Salvage Spine Stereotactic Body Radiotherapy. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The role of external beam radiotherapy in the management of bone metastases. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. France pubmed.ncbi.nlm.nih.gov

[Bone metastases radiotherapy: Multi-approaches literature review]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The role of vertebroplasty in metastatic spinal disease. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Conformal radiotherapy for vertebral bone metastasis]. [2017]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Fundamentals of Radiation Oncology for Treatment of Vertebral Metastases. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Kyphoplasty in combination with intraoperative radiotherapy. Technical and regulatory characteristics of a concept for treatment of vertebral metastases]. [2022]

11. United States 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. [2020]

12. India pubmed.ncbi.nlm.nih.gov

Use of C2 vertebroplasty and stereotactic radiosurgery for treatment of lytic metastasis of the odontoid process. [2020]