Thermal Ablation and Radiosurgery for Spinal Metastases

Overseen By Jing Li, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Radiosensitive tumors, Recent radiation, Pregnancy, 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

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two treatments, thermal ablation and stereotactic radiosurgery, for patients whose cancer has spread to the spine and may compress the spinal cord. Thermal ablation uses a laser to heat and shrink the tumor by destroying its cells. Stereotactic radiosurgery delivers a high dose of radiation precisely to the tumor while sparing healthy tissue. The trial seeks participants with solid tumors, such as lung, breast, or prostate cancer, who have spine involvement and no surgical options. Participants should have tumors in the middle or upper back (T2-T12) and be able to undergo MRI and lie flat for treatment. As a Phase 2 trial, this 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 trial coordinators or your doctor.

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

Research has shown that stereotactic radiosurgery safely treats cancer that has spread to the spine. Studies indicate it effectively reduces pain and controls tumor growth with few side effects. One study found it safe and effective even for patients who had previous radiation treatments.

Regarding thermal ablation, research suggests it is well-tolerated. A review found that radiofrequency ablation, a type of thermal ablation, has a low complication rate of about 3%, indicating it is generally safe for patients with spinal metastases. Both treatments provide pain relief and control tumor growth with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using thermal ablation and stereotactic radiosurgery (SSRS) for treating spinal metastases because of their precision and potential to minimize damage to healthy tissues. Thermal ablation uses heat to directly target and destroy cancer cells, which can be beneficial for patients who cannot undergo traditional surgery. SSRS, on the other hand, delivers high doses of radiation with pinpoint accuracy, reducing the risk of harming nearby spinal structures. Together, these treatments offer a non-invasive alternative to conventional surgery and radiation, potentially leading to fewer side effects and quicker recovery times for patients.

What evidence suggests that thermal ablation and stereotactic radiosurgery could be effective for spinal metastases?

Research has shown that thermal ablation, a treatment using heat to shrink tumors, effectively reduces pain in patients with cancer that has spread to the spine. Studies have found that 85% of patients experience significant pain relief, and 90% achieve good local tumor control three months after the procedure. Additionally, stereotactic radiosurgery, a precise type of radiation therapy, effectively controls tumors and relieves pain. It accurately targets spinal tumors while protecting healthy tissue, making it a safe and effective option for spine cancer. In this trial, participants will undergo both thermal ablation and stereotactic radiosurgery, potentially enhancing their effectiveness in treating spinal cancer that could press on the spinal cord. ^{2 5 6 7 8}

Who Is on the Research Team?

Jing Li

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with certain types of cancer that has spread to the spine, risking spinal cord compression. Eligible patients have a life expectancy over 3 months, can't be pregnant, and must agree to use contraception. They should not have had recent radiation or surgery at the same spine level and must be able to lie flat for treatment.

Inclusion Criteria

You have no more than 3 areas in your spine with cancer spread that need radiation treatment.

Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see Exclusion Criteria), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors.

You have good muscle strength in the affected body parts, scoring at least 4 out of 5 on a strength scale.

Exclusion Criteria

Pregnancy (because radiation has the potential for teratogenic or abortifacient effects).

The abnormal areas are not located between the second and twelfth bones of your spine.

You have severe compression on your spinal cord, causing acute problems with movement and strength in your limbs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up at 1, 3, 6, 9, and 12 months, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Radiosurgery
• Thermal Ablation Therapy

Trial Overview The study tests combining thermal ablation (using heat to destroy tumor cells) with stereotactic radiosurgery (targeted high-dose radiation sparing healthy tissue) in treating spinal metastases that could compress the spinal cord.

How Is the Trial Designed?

Group I: Treatment (thermal ablation, SSRS) Experimental Treatment 5 Interventions

Patients undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.

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

Approved in European Union as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in United States as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas
• Liver tumors
• Lung tumors
• Spinal cord tumors

Approved in Canada as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in Japan as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in China as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in Switzerland as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Stereotactic body radiation therapy (SBRT) is an effective and safe treatment for spinal bone metastasis, enhancing local control and improving patients' quality of life.

Key factors influencing treatment decisions include life expectancy, fracture risk, localization and size of metastases, and nerve compression, highlighting the need for further studies to identify which patients will benefit most from SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Treatment of Spinal Bone Metastasis. Cihan, YB.[2019]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

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]

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]

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 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 ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352806/

Stereotactic Radiosurgery in Metastatic Spine Disease—A ... This study highlights SRS as a safe and effective technique for managing spinal metastases. It offers good pain control and tumor control with minimal ...

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

Efficacy and safety of SBRT for spine metastases The currently available data including 5 randomized trials of SBRT for spine metastases confirm that spine SBRT is an effective therapy for ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1879850025002206

Long-Term Outcomes After Reirradiation With Spine ... Stereotactic body radiation therapy (SBRT) for spinal metastases is a safe, effective, and cost-effective treatment. As cancer incidence and ...

4. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00155-0/fulltext

Oncologic and Functional Outcomes After Stereotactic ... Pain response at 3 and 6 months post-SBRT was complete in 45.4% and 55.7%, partial in 26.9% and 13.1%, stable in 24.1% and 27.9%, and worse in ...

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

Spine Stereotactic Body Radiotherapy: Indications ... On the other hand, spine SBRT literature has reported complete response rates as high as 46% to 92%. Therefore, the data does suggest that while cEBRT may be ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2803269/

Clinical Results of Cyberknife® Radiosurgery for Spinal ... Cyberknife radiosurgery is clinically effective and safe for spinal metastases. It is true even in previously irradiated patients.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0167814023898632

Efficacy and safety of SBRT for spine metastases: A ... Based on this systematic review, SBRT for vertebral metastases achieved high rates of pain response with a pooled overall response rate of 83 %, and a 36 % ...

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2803769

Stereotactic Radiosurgery vs Conventional Radiotherapy ... Radiosurgery was not found to be superior to in terms of pain response at 3 months and, in fact, worse pain response was observed compared with conventional ...