Cement Augmentation for Cancer with Spinal Metastases

Overseen By Amol Ghia

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Prior radiotherapy, Prior surgery, Cord compression, Pregnancy, Lymphoma, 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

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

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding vertebral body cement augmentation can prevent spine fractures in patients with solid tumors that have spread to the spine. Patients will receive spine stereotactic radiosurgery, a precise high-dose radiation treatment. The trial compares standard treatment to treatment with additional cement augmentation. This approach may reduce fracture risk, lessen pain, and improve quality of life after radiation treatment. It suits patients with solid tumors and spinal metastases who are at high risk of spine fractures post-radiation. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, patients undergoing bisphosphonate therapy are allowed to continue.

What prior data suggests that vertebral body cement augmentation is safe for preventing vertebral compression fractures?

Research has shown that vertebral body cement augmentation is generally safe for patients with cancer that has spread to the spine. This procedure involves injecting a special cement into the spine and effectively relieves pain. Less invasive than other treatments, it helps maintain spinal stability. Studies suggest it is well-tolerated, with few serious side effects. Most patients experience reduced pain and improved quality of life after the procedure. Overall, vertebral cement augmentation appears to be a promising option for those with spinal issues due to cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about vertebral body cement augmentation for cancer patients with spinal metastases because it offers a novel approach to stabilizing weakened vertebrae. Unlike the standard treatment, which primarily involves stereotactic radiosurgery to target cancer cells, this technique involves injecting a special cement into the bone to reinforce its structure. This can potentially reduce pain and prevent further spinal fractures, offering a significant improvement in quality of life. Additionally, combining this method with radiosurgery within a short timeframe could enhance overall treatment effectiveness, providing faster and more comprehensive relief for patients.

What evidence suggests that vertebral body cement augmentation is effective for preventing vertebral compression fractures in patients with spinal metastases?

Research has shown that using a special cement in the spine, known as vertebral body cement augmentation, can help prevent fractures and reduce pain for patients with cancer that has spread to the spine. In this trial, some participants will undergo vertebral body cement augmentation. Studies have found that this procedure effectively relieves pain for many patients and is a less invasive way to manage symptoms. When spinal tumors cause fractures, using cement in the spine eases pain with few complications. Additionally, combining this method with other treatments like radiofrequency ablation has provided significant short-term pain relief. Overall, evidence suggests that cement augmentation is a promising way to improve the quality of life for patients with spine issues due to cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Amol J. Ghia

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with solid tumors that have spread to the spine, can lie flat, and are at high risk of spinal fractures post-radiosurgery. They should be relatively active (able to care for themselves), expected to live more than 3 months, and agree to use contraception. Those who've had prior spine surgery or radiotherapy at the same spot, severe vertebral damage, or certain cancers like lymphoma aren't eligible.

Inclusion Criteria

I have a confirmed solid tumor cancer that has spread to my spine.

All patients must be deemed at "high risk" of developing vertebral body fracture by having at least one of the following characteristics: Spine Instability Neoplastic Score classification of "Indeterminate" deemed as a score from 7 to 12, Pre-existing vertebral body fracture, Planned radiation dose of 24 Gy, All patients must have a vertebral body site to be treated located from T1 to L5, Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately, All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of M.D. Anderson Cancer Center; the only acceptable consent is the one approved by M.D. Anderson Institutional Review Board (IRB), Patients undergoing bisphosphonate therapy are allowed

I have received a specific radiation dose to my spine.

Exclusion Criteria

I have had surgery on my spine before, such as for tumor removal or bone support.

I experience clear, mechanical pain.

My spine condition involves significant disease affecting both sides at a specific level.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo stereotactic spinal radiosurgery and may receive vertebral body cement augmentation

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and quality of life every 3 months

2 years

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Radiosurgery
• Vertebral Body Cement Augmentation

Trial Overview

The study tests if injecting cement into vertebrae after high-dose radiation therapy (spine stereotactic radiosurgery) prevents fractures in patients with cancerous spine tumors. It's a phase II trial comparing patients receiving cement augmentation against those who don't, assessing pain relief and life quality.

How Is the Trial Designed?

Group I: Arm II (vertebral body cement augmentation) Experimental Treatment 4 Interventions

Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.

Group II: Arm I (standard of care) Active Control 3 Interventions

Patients undergo stereotactic spinal radiosurgery per standard of care.

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

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 radiotherapy (SBRT) and stereotactic radiosurgery (SRS) are becoming important treatment options for spinal metastases, providing targeted therapy for tumors near the spinal cord and vertebrae.

This review highlights the need for careful planning and consideration of radiobiology and potential toxicity, emphasizing that while SBRT/SRS offers promising benefits, there are limitations that must be addressed in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation for the spine: a review. Chawla, S., Schell, MC., Milano, MT.[2013]

The study evaluated 119 patients with spinal metastases treated with the CyberKnife (CK) system, comparing the new multileaf collimator (CK-M) to the traditional fixed cone collimator (CK-F). CK-M provided similar target coverage and local control rates while significantly reducing treatment time by 30%.

CK-M demonstrated effective dosimetric performance, achieving comparable outcomes to CK-F, making it a promising option for stereotactic body radiotherapy (SBRT) in spinal metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of multileaf collimator-based CyberKnife for spine stereotactic body radiation therapy. Kim, N., Lee, H., Kim, JS., et al.[2018]

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]

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]

Stereotactic radiosurgery (SRS) is a highly effective treatment for primary and metastatic spinal tumors, achieving an 85% pain improvement rate and a 90% local control rate, which can lead to better patient outcomes.

SRS is considered safe, with a low risk of complications, such as myelopathy occurring in only 0.4% of treated patients, making it a reliable option for managing spinal neoplasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for spinal neoplasms: current status and future perspective. Chang, UK., Lee, DH.[2017]

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