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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II clinical trial studies how well thermal ablation and spine stereotactic radiosurgery work in treating patients with cancer that has spread to the spine (spine metastases) and is at risk for compressing the spinal cord. Thermal ablation uses a laser to heat tumor tissue and helps to shrink the tumor by destroying tumor cells. Stereotactic radiosurgery delivers a large dose of radiation in a short time precisely to the tumor, sparing healthy surrounding tissue. Combining thermal ablation with stereotactic radiosurgery may be a better way to control cancer that has spread to the spine and is at risk for compressing the spinal cord.

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.

What data supports the effectiveness of the treatment for spinal metastases?

Research shows that stereotactic body radiation therapy (SBRT) is effective for treating spinal metastases, improving pain relief and local control compared to conventional radiation therapy. It also has lower retreatment rates and is considered safe, enhancing patients' quality of life. ^{1 2 3 4 5}

Is the treatment of spinal metastases with stereotactic radiosurgery and thermal ablation generally safe for humans?

Stereotactic radiosurgery, including methods like CyberKnife and SABR, has been used for treating spinal metastases and other conditions, showing promising results in controlling tumors. However, some serious complications have been reported, so strategies to reduce these risks are important to ensure safety. ^{1 4 6 7 8}

How is the treatment of spinal metastases with Stereotactic Radiosurgery and Thermal Ablation Therapy different from other treatments?

This treatment is unique because it uses precise, high-dose radiation (Stereotactic Radiosurgery) to target spinal metastases, which can improve pain control and reduce the need for retreatment compared to traditional radiation. It combines this with Thermal Ablation Therapy, which uses heat to destroy cancer cells, offering a novel approach for patients with good prognoses. ^{1 3 4 5 6}

Research Team

Jing Li

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for spinal metastases: experience at a single Brazilian institution. [2023]

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

Mature Local Control and Reirradiation Rates Comparing Spine Stereotactic Body Radiation Therapy With Conventional Palliative External Beam Radiation Therapy. [2022]

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

Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. [2023]

4. 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]

5. Thailand pubmed.ncbi.nlm.nih.gov

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

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical results of cyberknife(r) radiosurgery for spinal metastases. [2021]

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

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]

8. Switzerland 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. [2020]