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

63 Participants Needed

Trial Summary

What is the purpose of this trial?

The spread of cancer to the spine is referred to as spine metastasis. Spine metastases are a common complication of cancer and are frequently associated with significant back pain. This study is being done to help improve treatment for back pain caused by spinal metastases by comparing the effectiveness of two standard treatments. These two treatments include radiation therapy (RT) alone versus radiation therapy combined with radiofrequency ablation, with or without vertebral augmentation (PVA/RFA). In addition to RT or RT with PVA/RFA, will be continued with current pain medications.

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.

What data supports the idea that Radiation + Radiofrequency Ablation for Spinal Metastases is an effective treatment?

The available research shows that Radiation + Radiofrequency Ablation is effective for treating spinal metastases. Studies highlight that advanced radiation techniques, like stereotactic body radiotherapy (SBRT) and intensity-modulated radiotherapy (IMRT), improve the targeting of tumors and increase the dose of radiation safely. This leads to better control of the tumor and more pain relief compared to traditional methods. For example, one study found that increasing the radiation dose resulted in more pain relief for patients. These findings suggest that this treatment can be more effective than conventional radiation therapy alone. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Radiation + Radiofrequency Ablation for Spinal Metastases?

Research shows that advanced radiation therapies like stereotactic body radiation therapy (SBRT) and intensity-modulated radiotherapy (IMRT) can improve local tumor control and pain relief in spinal metastases by delivering precise, high-dose radiation. These methods enhance targeting accuracy and have been shown to be effective in managing skeletal metastases. ^{1 2 3 4 5}

What safety data is available for radiation and radiofrequency ablation treatment for spinal metastases?

The safety data for radiation and radiofrequency ablation treatment for spinal metastases includes several studies and reports. Stereotactic body radiation therapy (SBRT) using intensity-modulated radiotherapy (IMRT) is considered safe for treating spinal bone metastasis with good tumor control and pain response. Advanced radiotherapy techniques like IMRT and image-guided radiotherapy (IGRT) have been studied for their impact on toxicity, with some reports indicating low rates of gastrointestinal and genitourinary toxicities. Image-guided radiation therapy (IGRT) has been widely adopted in clinical practice, emphasizing quality and patient safety. Additionally, studies have shown no significant association between high-dose, hypofractionated IGRT and excessive wound complications in spinal metastasis treatment. ^{6 7 8 9 10}

Is the combination of radiation and radiofrequency ablation for spinal metastases generally safe for humans?

Research suggests that advanced radiation techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) are generally safe for treating spinal metastases, with a focus on minimizing side effects. However, there is a risk of wound complications, especially with higher doses, but no excessive complications were found in some studies. ^{6 7 8 9 10}

Is Radiation Therapy a promising treatment for spinal metastases?

Yes, Radiation Therapy is a promising treatment for spinal metastases. It uses advanced technology to deliver precise and high doses of radiation to tumors, improving control and reducing pain. This method is effective in targeting and managing spinal tumors. ^{1 3 6 10 11}

How is the treatment of Radiation + Radiofrequency Ablation for Spinal Metastases different from other treatments?

This treatment is unique because it combines radiation therapy, which uses high-energy rays to target and kill cancer cells, with radiofrequency ablation, a technique that uses heat to destroy cancer cells. The use of advanced technologies like stereotactic body radiation therapy (SBRT) and intensity-modulated radiotherapy (IMRT) allows for precise targeting of the tumor, potentially improving tumor control and reducing pain more effectively than conventional methods. ^{1 3 6 10 11}

Research Team

Rupesh R Kotecha, MD

Principal Investigator

Miami Cancer Institute (MCI) at Baptist Health South Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

References

1. England 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. [2023]

2. United States 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. [2022]

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

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

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

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

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

Safety and Efficacy of Dose-Escalated Radiation Therapy With a Simultaneous Integrated Boost for the Treatment of Spinal Metastases. [2023]

6. England 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]

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

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]

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

No association between excessive wound complications and preoperative high-dose, hypofractionated, image-guided radiation therapy for spine metastasis. [2022]

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

Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. [2022]

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

The integration of radiosurgery for the treatment of patients with metastatic spine diseases. [2014]