Cryoablation + SBRT for Bone Metastasis Pain

Overseen By Rahul A. Sheth, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pregnancy, Active infection, Cardiac arrhythmia, others

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

Compensation: Varies

Number of Visits: 10

Duration: 1-2 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining cryoablation (a procedure that freezes and kills cancer cells) with stereotactic body radiation therapy (a targeted radiation treatment) can relieve pain more effectively than radiation alone for patients with cancer that has spread to their bones. Bone metastases often cause significant pain, and current treatments may not always provide enough relief. The trial includes patients with cancer that has spread to their bones, causing significant pain, and who haven't received certain prior treatments on the target area. Participants must have a specific type of cancer and significant pain from a bone tumor. As an unphased study, this trial offers patients the opportunity to explore innovative pain relief options for bone metastases.

Will I have to stop taking my current medications?

If you are taking antiplatelet or anticoagulation medications, you may need to stop them 48 hours before the procedure, unless the study doctor decides otherwise. Other standard treatments like chemotherapy, immunotherapy, or targeted therapy are allowed.

What prior data suggests that cryoablation combined with stereotactic body radiation therapy is safe for treating bone metastasis pain?

Research has shown that cryoablation safely treats pain from cancer that has spread to the bones. In one study, only 2% of patients experienced a major issue, specifically an infection at the treatment site. Most patients found the procedure simple and experienced quick, lasting pain relief.

For stereotactic body radiation therapy (SBRT), studies indicate it is both effective and safe, often providing better pain relief than traditional radiation methods. SBRT is known for controlling pain and the disease without major side effects. Overall, both cryoablation and SBRT are considered safe options for treating pain from bone metastases. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining cryoablation with stereotactic body radiation therapy (SBRT) for bone metastasis pain because it offers a potentially powerful one-two punch. Unlike standard treatments like conventional radiation or pain medications, this approach uses cryoablation to freeze and destroy tumor tissue directly, possibly offering immediate relief. Following this, SBRT delivers highly focused radiation, which can target any remaining cancerous cells with precision, minimizing damage to surrounding healthy tissue. This combination could lead to quicker and longer-lasting pain relief compared to conventional methods.

What evidence suggests that cryoablation combined with SBRT could be effective for pain relief from bone metastases?

Studies have shown that combining cryoablation with stereotactic body radiation therapy (SBRT) effectively relieves pain from cancer that has spread to the bones. In this trial, participants in Arm B will receive both cryoablation and SBRT, which may offer better pain relief than SBRT alone. Cryoablation freezes and kills cancer cells, and research indicates that it not only alleviates pain but also controls tumor growth with few complications. This combination targets cancer more precisely, potentially providing better outcomes for patients with painful bone metastases. Meanwhile, participants in Arm A will receive SBRT alone. The trial aims to enhance pain relief compared to using radiation therapy by itself. ^{6 7 8 9 10}

Who Is on the Research Team?

Rahul A Sheth, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer patients with painful bone metastases from specific cancers like renal, urothelial, prostate, sarcoma, thyroid, colorectal carcinoma and melanoma. Participants must have a pain score of at least 4/10 on the BPI scale for the affected bone area and a life expectancy of 3+ months. They should be able to stop antiplatelet or anticoagulation meds before procedures if needed.

Inclusion Criteria

Your blood clotting test (INR) should be less than 1.5 within 6 weeks of screening.

You are expected to live for at least 3 more months.

My cancer can be treated with freezing and targeted radiation, as approved by the study leaders.

Exclusion Criteria

My cancer has spread to my spine or skull.

I am not on any experimental drugs but may be on standard cancer treatments.

I have a confirmed fracture at the cancer site that cannot be stabilized with a minimally invasive procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo stereotactic body radiation therapy for 1 fraction or cryoablation followed by stereotactic body radiation therapy within 10 days

1-2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for safety, pain response, and local tumor control

24 weeks

9 visits (in-person) at 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cryoablation
• Stereotactic Body Radiation Therapy

Trial Overview The CROME Trial is testing whether combining cryoablation (freezing cancer cells using special needles) with stereotactic body radiation therapy provides better pain relief for bone metastases than radiation alone. Patients will either receive both treatments or just radiation to compare effectiveness.

How Is the Trial Designed?

Group I: Arm B (cryoablation, SBRT) Experimental Treatment 3 Interventions

Patients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction. Alternatively, patients may receive stereotactic body radiation therapy initially, followed by cryoablation."

Group II: Arm A (SBRT) Active Control 2 Interventions

Patients undergo stereotactic body radiation therapy for 1 fraction.

Cryoablation is already approved in United States, European Union for the following indications:

Approved in United States as Cryoablation for:

• Liver cancer
• Kidney cancer
• Bone cancer
• Pain management

Approved in European Union as Cryoablation for:

• Liver cancer
• Kidney cancer
• Bone cancer
• Pain management

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

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]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

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 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]

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 ablative radiotherapy (SABR) shows high effectiveness for oligometastatic breast cancer, achieving local control rates of 97% at 1 year and 90% at 2 years, based on a meta-analysis of 10 studies involving 467 patients.

SABR is associated with a low toxicity rate, with only 4.1% of patients experiencing grade 2 or 3 side effects, indicating it is a safe treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy to treat breast cancer oligometastases: A systematic review with meta-analysis. Viani, GA., Gouveia, AG., Louie, AV., et al.[2021]

In a study of 20 patients with spine bone metastases treated with stereotactic radio-therapy (SBRT), 74% experienced complete pain relief at three months, indicating a strong analgesic response.

The treatment was well-tolerated, with no severe toxicity (Grade 3 or higher) reported, suggesting that SBRT is a safe and effective option for pain management in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy (SBRT) for pain management in spine bone metastases]. Jara O, N., Solé P, C., Solé Z, S.[2020]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

Stereotactic radiotherapy (SBRT) shows promise in improving pain relief and local control in patients with bone metastases, with higher pain response rates compared to conventional radiotherapy, based on a systematic review of 57 studies involving 3995 patients.

Despite the positive findings, the review highlights significant variability in study designs and treatment protocols, indicating a need for large randomized trials to accurately assess the efficacy and safety of SBRT for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of the Role of Stereotactic Radiotherapy for Bone Metastases. Spencer, KL., van der Velden, JM., Wong, E., et al.[2021]

Stereotactic body radiotherapy (SBRT) offers a promising treatment option for painful bone metastases, delivering high doses of radiation accurately over one to a few sessions, which may improve patient outcomes compared to conventional radiotherapy.

SBRT is particularly beneficial for treating tumors that are usually resistant to radiation, although it is important to consider potential toxicity to surrounding healthy tissues and the patterns of local treatment failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy in the management of painful bone metastases. Jhaveri, P., Teh, BS., Bloch, C., et al.[2008]

Citations

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Cryoablation Combined With Stereotactic Body Radiation ... The goal of this trial is to compare how well cryoablation in combination with radiation therapy works to radiation therapy alone when given to cancer patients ...

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a comprehensive systematic review and meta-analysis - PMC PCA is an effective alternative treatment for spinal metastases, offering pain relief and local tumor control with low complication rates in appropriately ...

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Cryoablation + SBRT for Bone Metastasis Pain This trial compares cryoablation combined with stereotactic body radiation therapy to stereotactic body radiation therapy alone to see how well they work in ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-07368

Cryoablation Combined with Stereotactic Body Radiation ... The goal of this trial is to compare how well cryoablation in combination with radiation therapy works to radiation therapy alone when given to cancer patients ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S221213742200015X

State-of-the-art of minimally invasive treatments of bone ... Radiotherapy and chemotherapy are vital to the treatment of bone metastases and can provide some pain relief and control of new metastases throughout the body.

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PERCUTANEOUS IMAGE - GUIDED CRYOABLATION OF ... Percutaneous cryoablation is a safe, effective and durable method for palliation of pain due to metastatic disease involving bone.

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Cryoablation for Palliation of Painful Bone Metastases Cryoablation is a safe and minimally invasive therapy option that provided rapid and durable pain relief, as well as an improved quality of life ...

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Safety and Efficacy of Cryoablation for the Palliation ... This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors. Detailed Description.

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Percutaneous image-guided cryoablation of painful bone ... Conclusion. PCA is a safe and valid treatment option for pain and local disease control in cases of painful bone metastases after failed standard first-line ...

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Percutaneous image‐guided cryoablation of painful ... One of 61 (2%) patients had a major complication with osteomyelitis at the site of ablation. CONCLUSIONS: Percutaneous cryoablation is a safe, ...