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

87 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well cement augmentation works in preventing vertebral body compression fracture following spine stereotactic radiosurgery in patients with solid tumors that have spread to the spine. Spine stereotactic radiosurgery delivers a high dose of radiation to vertebral metastases and can sometimes lead to a vertebral compression fracture. Using body cement on the largest part of the vertebra (a procedure called vertebral body cement augmentation) may help prevent a fracture after stereotactic spinal radiosurgery. It may also lessen pain and improve quality of life in patients with solid tumors and spinal metastases undergoing this surgery.

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 data supports the effectiveness of the treatment for spinal metastases?

Research shows that stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) are effective treatments for spinal metastases, improving pain relief and local tumor control compared to traditional methods. These treatments are noninvasive and have been shown to reduce the need for retreatment, offering a good balance between effectiveness and minimizing side effects. ^{1 2 3 4 5}

Is stereotactic radiosurgery safe for treating spinal metastases?

Stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (SBRT) are generally considered safe for treating spinal metastases, with rare complications reported. The risk of myelopathy (spinal cord damage) is estimated to be very low, at about 0.4% of treated patients. ^{1 3 6 7 8}

How is the treatment Stereotactic Radiosurgery (SRS) unique for spinal metastases?

Stereotactic Radiosurgery (SRS) is unique because it is a noninvasive treatment that delivers precise, high-dose radiation to spinal metastases, improving pain relief and local control with fewer retreatments compared to conventional radiotherapy. It offers a balance between effectiveness and minimizing side effects, often using advanced technology like CyberKnife or Gamma Knife. ^{1 2 3 9 10}

Research Team

Amol J. Ghia

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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 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 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]

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 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]

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]

References

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

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Nationwide Study of Stereotactic Radiosurgery in a Newly Diagnosed Spine Metastasis Population. [2018]

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

Stereotactic body radiation for the spine: a review. [2013]

5. 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]

6. Italy pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for spinal neoplasms: current status and future perspective. [2017]

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

Image-guided stereotactic spine radiosurgery on a conventional linear accelerator. [2016]

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

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

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

Single-fraction radiosurgery for the treatment of spinal breast metastases. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Clinical outcomes of multileaf collimator-based CyberKnife for spine stereotactic body radiation therapy. [2018]