Radiation + Radiofrequency Ablation for Spinal Metastases

Overseen By Rupesh R Kotecha, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baptist Health South Florida

Must not be taking: Chemotherapy

Disqualifiers: Myeloma, Lymphoma, Non-ambulatory, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines treatments for back pain caused by cancer that has spread to the spine. Researchers compare the effects of radiation therapy alone to a combination of radiation therapy and radiofrequency ablation, a procedure that uses heat to destroy cancer cells. This study may suit individuals experiencing significant back pain due to spinal metastases identified through imaging tests. Participants must continue their current pain medications during the trial. As an unphased trial, this study offers a unique opportunity to explore innovative treatment combinations for managing back pain from spinal metastases.

Do I have to stop taking my current medications for the trial?

No, you can continue taking your current pain medications during the trial.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, it mentions that you will continue with your current pain medications during the study.

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

Research shows that both radiotherapy and radiofrequency ablation (RFA) are safe options for treating cancer spread to the spine.

Studies have found radiotherapy to be both effective and safe. Specifically, stereotactic body radiation therapy (SBRT) relieves pain in 80% to 100% of patients, often within two weeks. Importantly, this treatment does not increase the risk of spine fractures, a common concern with spine treatments.

Radiofrequency ablation, often combined with a procedure to strengthen the spine, also has a good safety record. Research reported that RFA significantly reduces pain and controls tumors well, with a low complication rate of 3%. Serious complications were rare, and any temporary issues usually resolved on their own.

Both treatments have demonstrated promising safety results, making them well-tolerated options for those with painful cancer spread to the spine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining radiation therapy with radiofrequency ablation for spinal metastases because it may offer enhanced effectiveness compared to standard radiation therapy alone. The radiofrequency ablation technique uses heat to destroy cancer cells, potentially leading to more aggressive tumor reduction. This combination approach not only targets the tumor directly but also supports vertebral structure through vertebral augmentation, which might improve pain relief and quality of life for patients. By integrating these treatments, there's potential for a more comprehensive attack on the cancer and better overall patient outcomes.

What evidence suggests that this trial's treatments could be effective for spinal metastases?

Research has shown that radiotherapy, one of the treatments in this trial, effectively relieves pain for many patients with cancer spread to the spine, easing pain for 80% to 100% of patients within two weeks. Another treatment option, radiofrequency ablation (RFA), significantly reduces pain and effectively controls the tumor, with a low chance of regrowth. One study found that combining RFA with a procedure to strengthen the spine was safe and helped manage pain in patients with cancer spread to the spine. Both treatments in this trial help control cancer in the spine and reduce discomfort. ^{1 2 3 6 7}

Who Is on the Research Team?

Rupesh R Kotecha, MD

Principal Investigator

Miami Cancer Institute (MCI) at Baptist Health South Florida

Are You a Good Fit for This Trial?

This trial is for adults with cancer that has spread to the spine, causing significant back pain. They must have a certain level of physical ability (Zubrod Performance Status 0-3), not be pregnant, agree to use birth control if applicable, and have a specific level of back pain despite medication. Excluded are those with certain cancers like myeloma or lymphoma, non-walkers, prior radiation on the spine area, or needing immediate surgery.

Inclusion Criteria

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

My pain score is 5 or higher for the area where I need treatment.

Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria

I need pain relief for more than 2 areas of my spine.

My neurological condition is worsening quickly.

I have had radiation treatment on my spine before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either radiation therapy alone or radiation therapy combined with radiofrequency ablation and/or vertebral augmentation

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Radiation Therapy
• Radiofrequency Ablation (RFA)

Trial Overview The study compares two treatments for spinal metastases-related back pain: Radiation Therapy alone versus Radiation Therapy combined with Radiofrequency Ablation and possibly Vertebral Augmentation. The goal is to see which treatment better alleviates pain while patients continue their usual pain medications.

How Is the Trial Designed?

Group I: Radiotherapy plus radiofrequency ablation Experimental Treatment 2 Interventions

Radiotherapy plus radiofrequency ablation / vertebral augmentation(Combination therapy)

Group II: Radiotherapy Experimental Treatment 1 Intervention

Radiotherapy alone

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

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Published Research Related to This Trial

Image-guided stereotactic body radiation therapy (SBRT) is an effective treatment for pain control in patients with vertebral oligometastasis, potentially offering better outcomes than conventional external-beam radiation therapy.

SBRT allows for the delivery of high doses of radiation with minimal toxicity, which may improve local tumor control, especially in tumors that are typically resistant to radiation, although more research is needed to understand long-term effects on normal tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond the conventional role of external-beam radiation therapy for skeletal metastases: new technologies and stereotactic directions. Yu, HH., Hoffe, SE.[2017]

Radiosurgery is increasingly recommended as a primary treatment for spinal metastasis due to its ability to deliver precise and higher doses of radiation directly to tumors.

When combined with minimally invasive surgery to reduce tumor load, this advanced radiation therapy offers improved local control of tumors compared to traditional external beam radiation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The integration of radiosurgery for the treatment of patients with metastatic spine diseases. Sharan, AD., Szulc, A., Krystal, J., et al.[2014]

This study is a randomized controlled trial involving 60 patients with spinal bone metastases, comparing the effectiveness of single-fraction intensity-modulated radiation therapy (1 × 24 Gy) versus fractionated radiation therapy (10 × 3 Gy) for pain relief.

The primary goal is to assess pain relief at 3 months post-treatment, along with secondary outcomes including quality of life and local tumor control, highlighting the potential of SBRT as a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial. Rief, H., Katayama, S., Bruckner, T., et al.[2018]

In a study of 165 patients undergoing spine surgery for metastasis, those receiving high-dose hypofractionated image-guided radiation therapy (IGRT) had a lower rate of wound complications (6%) compared to those receiving conventional radiation therapy (XRT) (17%), although the difference was not statistically significant.

The findings suggest that IGRT, which treats fewer vertebral bodies, may lead to better wound healing outcomes, and higher doses per fraction may be associated with a lower risk of complications, indicating a potential benefit of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No association between excessive wound complications and preoperative high-dose, hypofractionated, image-guided radiation therapy for spine metastasis. Keam, J., Bilsky, MH., Laufer, I., 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]

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]

This study involves 120 patients with spinal bone metastases receiving stereotactic body radiation therapy (SBRT) with different fractionation schedules to evaluate local tumor control and safety.

The trial aims to compare the effectiveness of SBRT with and without simultaneous integrated boost (SIB) in improving tumor targeting and patient outcomes, including pain relief and quality of life, over a follow-up period of three to six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial. Sprave, T., Welte, SE., Bruckner, T., et al.[2023]

In a study comparing two radiotherapy regimens for spinal metastases, the dose-escalation group receiving 60-66 Gy showed significantly better pain relief outcomes after one and three months compared to the 30-Gy group, with complete pain relief rates of 73.69% and 41.38%, respectively.

The dose-escalation regimen not only improved pain relief but also demonstrated a trend towards longer overall survival and lower acute radiation toxicities, while no late radiation toxicities were observed in either group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose escalation by image-guided intensity-modulated radiotherapy leads to an increase in pain relief for spinal metastases: a comparison study with a regimen of 30 Gy in 10 fractions. He, J., Xiao, J., Peng, X., et al.[2022]

In a study of 421 patients undergoing salvage radiotherapy (SRT) after prostate surgery, the use of advanced techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) significantly reduced the incidence of late gastrointestinal (GI) toxicities to 4.8%.

However, increasing the radiation dose to 68 Gy or more was linked to a higher risk of genitourinary (GU) toxicities, indicating that while advanced techniques can help minimize some side effects, higher doses may still pose risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. Tomita, N., Uchiyama, K., Mizuno, T., et al.[2021]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

In a study of 58 patients with spinal metastases treated with intensity modulated radiation therapy using a simultaneous integrated boost (SSIB), 82% of those who reported pain before treatment experienced significant pain relief after therapy, indicating high efficacy in pain management.

The treatment demonstrated a local control rate of 88% at one year and 74% at two years, with limited acute toxicities, suggesting that SSIB is a safe and effective option for patients with spine metastases who cannot undergo stereotactic radiosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Dose-Escalated Radiation Therapy With a Simultaneous Integrated Boost for the Treatment of Spinal Metastases. Florez, MA., De, B., Cavazos, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10950794/

Combination radiofrequency ablation and vertebral cement ... Significant reduction in numerical pain scores. Effective local tumor control with low rates of tumor progression. Good safety profile with ...

2. jtss.org jtss.org/articles/is-radiofrequency-ablation-in-conjunction-with-vertebral-augmentation-an-effective-option-in-painful-spinal-metastasis/jtss.galenos.2021.22932

IS RADIOFREQUENCY ABLATION IN CONJUNCTION ... In this study, we retrospectively evaluated the efficacy and safety of RFA in conjunction with vertebral augmentation in pain palliation in painful spinal ...

3. mdpi.com mdpi.com/1718-7729/31/9/401

Exploring the Efficacy of Combining Radiofrequency ... Radiographic local tumor control rates were 89% (41/46) at 3 months, 74% (26/35) at 6 months, and 70% (21/30) at 1 year post treatment. The ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S187887502200434X

Radiofrequency Ablation and Augmentation in the ... This retrospective study included 41 patients with metastatic spinal tumors. There were 19 women and 22 men with a mean age of 67 years (range, 45–87 years) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8571892/

What is the effectiveness of radiofrequency ablation in ... Low quality evidence has proven RFA to be safe and effective in reducing pain and disability, especially in the short-term.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38510810/

Combination radiofrequency ablation and vertebral cement ... The findings of this meta-analysis reveal that the implementation of RFA in conjunction with VCA for the treatment of spinal metastatic ...

7. ajronline.org ajronline.org/doi/10.2214/AJR.20.23494?doi=10.2214/AJR.20.23494

Complications of Percutaneous Radiofrequency Ablation of ... CONCLUSION. Radiofrequency ablation of spinal osseous metastases is safe with a 3.0% rate of complications. The spinal column is the most common ...