Spine Radiosurgery for Spinal Cancer Spread

Overseen By Alyssa Yauger

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Stanford University

Disqualifiers: Pediatric, Pregnant, Myeloma, Lymphoma, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

274 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two radiosurgery approaches for treating cancer that has spread to the spine. It aims to determine if multiple smaller doses of radiation (multi-fraction spine SRS, or Fractionated Stereotactic Radiosurgery) control tumors more effectively than a single larger dose (single-fraction spine SRS, or Stereotactic Body Radiation Therapy). Individuals with cancer that has spread to 1 to 3 parts of their spine (neck, mid-back, or lower back) and who experience related issues may be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking advancements in cancer treatment.

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?

A previous study on stereotactic radiosurgery (SRS) for cancer that has spread to the spine showed excellent results in controlling the cancer and relieving pain. Research has shown that administering this treatment over two sessions, known as multi-fraction spine SRS, is safe and effective. It provides good pain relief and manages the tumor well, with few side effects.

For single-session spine SRS, studies suggest it is also safe and effective, with many patients experiencing significant pain relief. One study reported that 96% of patients had pain relief after treatment. Although there is a small risk of bone fracture with single-session treatments, this risk remains generally low.

Both multi-fraction and single-fraction SRS methods are well-tolerated and have demonstrated promising safety in treating cancer that has spread to the spine. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about spine stereotactic radiosurgery (SRS) for spinal cancer spread because it offers a more precise and potentially more effective approach than traditional radiation therapy. Unlike conventional radiation, which can take several weeks and affect surrounding healthy tissue, SRS delivers high doses of radiation directly to the tumor in just one or two sessions, minimizing damage to nearby areas. The multi-fraction spine SRS (14 Gy x 2) spreads the treatment over two sessions, while the single-fraction spine SRS (22 Gy x 1) delivers it all at once, offering flexibility based on patient needs and tumor characteristics. This precision could lead to quicker relief from symptoms and reduce the overall treatment time, providing a significant advantage over existing options.

What evidence suggests that this trial's treatments could be effective for spinal cancer spread?

Research has shown that stereotactic radiosurgery (SRS) effectively manages cancer that has spread to the spine, controlling the tumor and relieving pain. In this trial, participants will receive either a single high dose of spine SRS or multiple lower doses. Studies have found that a single high dose of SRS controls these tumors better than multiple lower doses. Specifically, a single high dose has relieved pain in 96% of cases. Conversely, spreading out the treatment over multiple sessions tends to be less effective in controlling the tumor. Overall, a single high dose of SRS is considered a safe and effective treatment for cancer that has spread to the spine. ^{1 2 3 5 6}

Who Is on the Research Team?

Erqi Pollom, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with cancer that has spread to the spine. Specific details about who can join are not provided, but typically participants would need a confirmed diagnosis and may have certain health requirements.

Inclusion Criteria

Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document

I am 18 or older with a confirmed diagnosis of metastatic cancer.

I agree to use effective birth control during the study.

Exclusion Criteria

I have had or will have radiation therapy in the same area being studied.

I cannot have an MRI or CT scan, but I can have a CT if I have a pacemaker.

My cancer is either myeloma or lymphoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spine Stereotactic Radiosurgery (SRS) with either 22 Gy in 1 fraction or 28 Gy in 2 fractions

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, quality of life, and tumor control

2 years

1, 3, 6, 12, 18, and 24 months following SRS

What Are the Treatments Tested in This Trial?

Interventions

• Multi-fraction spine SRS
• Single-fraction spine SRS

Trial Overview

The study is testing two different radiation therapy schedules for treating spinal tumors: one single high-dose treatment versus two slightly lower doses on separate days. Patients will be randomly assigned to one of these treatments.

How Is the Trial Designed?

Group I: Single-fraction spine SRS Experimental Treatment 1 Intervention

Single-fraction spine SRS (22 Gy x 1)

Group II: Multi-fraction spine SRS Experimental Treatment 1 Intervention

Multi-fraction spine SRS (14 Gy x 2)

Multi-fraction spine SRS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Radiosurgery for:

• Spinal metastases
• Vertebral tumors
• Bone metastases

Approved in European Union as Stereotactic Radiosurgery for:

• Spinal metastases
• Vertebral tumors
• Bone metastases

Approved in Canada as Stereotactic Radiosurgery for:

• Spinal metastases
• Vertebral tumors
• Bone metastases

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

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]

In a study of 156 patients with spinal metastases, those treated with three-fraction (3F) SBRT experienced greater pain relief and improved functional outcomes compared to those receiving single-fraction (SF) SBRT, despite starting with worse baseline conditions.

Both treatment groups achieved similar local tumor control, indicating that while 3F-SBRT may offer better pain management and functional improvement, it does not compromise the effectiveness of tumor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient outcomes and tumor control in single-fraction versus hypofractionated stereotactic body radiation therapy for spinal metastases. Park, C., Howell, EP., Mehta, VA., et al.[2023]

Patients receiving stereotactic body radiation therapy (SBRT) for metastatic spine tumors experienced a significantly higher rate of vertebral body fractures (22.22%) compared to those receiving conventionally fractionated external-beam radiation therapy (EBRT) (6.67%), indicating a safety concern with SBRT.

Despite the increased fracture risk, SBRT demonstrated a higher initial local control rate (86.67%) compared to EBRT (77.78%), although this difference in local control was not significant after adjusting for survival analysis, likely due to the presence of more radiosensitive tumors in the EBRT group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vertebral body fracture rates after stereotactic body radiation therapy compared with external-beam radiation therapy for metastatic spine tumors. Vargas, E., Susko, MS., Mummaneni, PV., 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]

Cyberknife stereotactic body radiation therapy (SBRT) delivers high doses of radiation in fewer sessions, making it a promising alternative to surgery for early-stage primary cancers and for patients with oligometastatic disease.

Despite some uncertainties about the effects of hypofractionation, early results show good local control and patient tolerance, leading to increased use of this treatment under strict quality assurance and ongoing clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. Thariat, J., Marcié, S., Marcy, PY., et al.[2018]

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]

Stereotactic body radiotherapy (SBRT) was successfully used in 60 patients with progressive spine metastasis after previous radiation, showing a median overall survival of 11 months and a median progression-free survival of 9 months.

The treatment resulted in 93% of patients experiencing stable or improved disease, with 65% reporting pain relief, and it was associated with minimal toxicity, primarily fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy reirradiation for recurrent epidural spinal metastases. Mahadevan, A., Floyd, S., Wong, E., et al.[2011]

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]

In a study of 482 patients with spine metastases treated with SBRT, escalating the dose to 28 Gy in 2 fractions resulted in significantly better local control rates compared to 24 Gy, with lower cumulative incidences of local failure at 6, 12, and 24 months.

The higher dose of 28 Gy did not increase the risk of vertebral compression fractures, indicating that it is a safe and effective option for improving treatment outcomes in patients with spine metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Escalated 2-Fraction Spine Stereotactic Body Radiation Therapy: 28 Gy Versus 24 Gy in 2 Daily Fractions. Zeng, KL., Abugarib, A., Soliman, H., 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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11846292/

Single- versus multi-fraction spine stereotactic radiosurgery ...

For patients with spine metastases, stereotactic radiosurgery (SRS) provides excellent local control and pain response.

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thejns.org

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Single-fraction versus multifraction stereotactic radiosurgery ...

This study highlights the superiority of high-dose single-fraction regimen in controlling spinal metastatic tumors compared with multifraction lower doses.

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thegreenjournal.com

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

Efficacy and safety of SBRT for spine metastases

In this study, we summarize the available evidence for stereotactic body radiotherapy (SBRT) in the treatment of spinal metastases. Materials ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1529943025000786

Single versus multiple fraction stereotactic spine ...

We proposed a randomized study to determine the safety of delivering a single 16 Gy dose of SSRS versus a 3-fraction 24 Gy dose of SSRS.

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advancesradonc.org

advancesradonc.org/article/S2452-1094(18)30232-X/fulltext

Outcomes in the radiosurgical management of metastatic ...

Patients treated with a hypofractionated course compared with a single fraction had worse radiologic local control (HR: 2.63; 95% CI, 1.27-5.45). No patients ...

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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 ...