Spine Stereotactic Radiosurgery for Spinal Cancer

Overseen By Ehsan Balagamwala, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Hematologic malignancies, Multiple cancers, 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: 2

Duration: 1-2 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of radiation treatment called spine stereotactic radiosurgery (SRS) for individuals with spinal cancer. The researchers aim to determine if administering the treatment in one or two sessions can reduce pain and other symptoms while minimizing the risk of vertebral compression fractures, which are small bone breaks that often aren't painful. Individuals with cancer that has spread to specific areas of the spine, who have mild to moderate neurological issues and can handle the procedures, might be suitable candidates for this trial. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

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?

Research shows that spine stereotactic radiosurgery (SRS) is generally safe and effective for treating spine cancer. Studies have found that it provides lasting pain relief and helps control the disease. In one study, 61% of patients survived after one year, and only 9% experienced vertebral compression fractures, which can occur after treatment.

Both the single fraction (a one-time high-dose treatment) and two fraction (split into two high-dose treatments) methods are usually well-tolerated by patients. A long-term study showed that the chances of cancer returning in the treated area were low, indicating good safety and effectiveness.

In summary, evidence suggests that spine SRS, whether done in one or two sessions, is generally safe for treating spine cancer. However, like any medical treatment, there are risks, such as the possibility of spine fractures, but these are not common. ^{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 because it offers a precise, high-dose radiation treatment in fewer sessions compared to conventional therapies. Traditional radiation treatment often requires multiple sessions over several weeks, while Spine SRS can deliver similar or greater doses in just one or two fractions. This approach not only potentially reduces treatment time and inconvenience for patients but also aims to target tumors more accurately, sparing healthy surrounding tissue and minimizing side effects.

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

Studies have shown that Spine Stereotactic Radiosurgery (SRS) effectively treats spinal cancer. Research indicates that SRS delivers strong radiation doses directly to the cancer while protecting nearby healthy tissues. This precise targeting reduces pain and nerve problems caused by spinal tumors. Evidence supports that SRS is both safe and cost-effective for treating spine metastases, which are cancerous growths that have spread to the spine. In this trial, participants will receive either a single treatment session (Arm 1) or two treatment sessions (Arm 2). Initial findings suggest that both approaches help manage symptoms and may lower the risk of spine fractures, though ongoing research is comparing these approaches. ^{1 2 3 6 7}

Who Is on the Research Team?

Samuel T. Chao, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with cancer that has spread to their spine, affecting up to three separate sites without causing spinal cord compression. Participants must be in good physical condition (KPS ≥ 70), able to undergo MRI scans, and not pregnant. Those who've had prior radiation at the index site may join, but not if they've had specific spine treatments or have certain types of cancer like lymphoma.

Inclusion Criteria

Negative pregnancy test within four weeks of registration for women of childbearing potential.

My overall health status fits within a specific range and my cancer is either controlled or not, depending on other health factors.

History and physical within four weeks of registration.

Exclusion Criteria

You have an ongoing connective tissue disease that is currently active.

My cancer has spread to more than 5 levels of my spine.

I have a spinal cord compression that needs urgent care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spine stereotactic radiosurgery (sSRS) in either one or two sessions depending on the assigned group

1-2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for vertebral compression fractures, quality of life, local control, pain control, and toxicity

12 months

Follow-up MRIs at 1 month, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Spine SRS in 1 fraction
• Spine SRS in 2 fraction

Trial Overview The study compares single-session versus two-session Spine Stereotactic Radiosurgery (sSRS) for treating vertebral metastases. It aims to determine which method better prevents vertebral compression fractures after delivering high-dose x-ray treatments focused on the affected areas of the spine.

How Is the Trial Designed?

Group I: Arm 1 - Single fraction Experimental Treatment 6 Interventions

sSRS 18 Gy in 1 fraction

Group II: Arm 2 - Two fraction Active Control 6 Interventions

sSRS 24 Gy in 2 fractions

Spine SRS in 1 fraction is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Spine Stereotactic Radiosurgery for:

• Vertebral metastases
• Spinal tumors
• Pain relief
• Neurological symptoms

Approved in European Union as Spine Radiosurgery for:

• Vertebral metastases
• Spinal tumors
• Pain relief
• Neurological symptoms

Approved in Canada as Stereotactic Body Radiation Therapy (SBRT) for:

• Vertebral metastases
• Spinal tumors
• Pain relief
• Neurological symptoms

Approved in Japan as Spine Stereotactic Radiosurgery for:

• Vertebral metastases
• Spinal tumors
• Pain relief
• Neurological symptoms

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) is an emerging treatment for spinal metastases, allowing for the delivery of high doses of radiation to improve tumor control and provide relief from symptoms.

SBRT is particularly beneficial for patients with complex cases, such as those who have previously received radiation at the same site or have tumors that are resistant to conventional treatments, and can be used alongside other therapies like spinal decompression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy: an emerging treatment for spinal metastases. Dahele, M., Fehlings, MG., Sahgal, A.[2019]

A comprehensive risk analysis of the paraspinal SBRT workflow identified 74 potential failure modes across various phases, with treatment planning being a significant source of safety concerns.

The highest risks were linked to inadequate evaluation of previous radiotherapy, incorrect imaging registration, and undetected patient movement, prompting the implementation of targeted remedies like staff education and improved imaging protocols to enhance treatment safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. Lee, S., Lovelock, DM., Kowalski, A., et al.[2021]

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]

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) and stereotactic radiosurgery (SRS) are effective techniques for delivering high doses of radiation to spinal metastases, especially in cases where conventional palliative radiotherapy has failed.

These advanced techniques allow for safe re-irradiation of tumors near the spinal cord, which is crucial since traditional re-irradiation methods may not be possible due to the risk of damaging the spinal cord.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of stereotactic body radiotherapy and stereotactic radiosurgery in the re-irradiation of metastatic spinal tumors. Jain, AK., Yamada, YJ.[2014]

Stereotactic body radiotherapy (SBRT) demonstrated high local control rates for spinal metastasis, with 83% at 1 year and 71% at 2 years, and a median overall survival of 30.6 months among 26 patients with 32 lesions.

The treatment was found to be safe, with only 16% of patients experiencing acute pain flare, which was manageable, and no cases of radiation-induced myelopathy reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy as a primary treatment for spinal metastasis: a single institution experience. Yeung, WME.[2021]

Stereotactic radiosurgery (SRS) is an advanced treatment option for spine metastases that has shown high rates of pain relief and tumor control, making it an effective noninvasive alternative for patients.

The shift towards a more aggressive treatment approach for spine metastases, supported by better imaging and early diagnosis, highlights the growing importance of SRS in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spine radiosurgery for spinal metastases: indications, technique and outcome. Harel, R., Zach, L.[2014]

In a study of 80 patients treated with postoperative spine stereotactic body radiotherapy (SBRT), a higher total dose of 18-26 Gy delivered in 1-2 fractions was associated with better local control (LC) rates, achieving an 84% LC rate at one year.

The presence of lower postoperative epidural disease grades (0 or 1) significantly predicted improved local control, highlighting the importance of disease status in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical resection of epidural disease improves local control following postoperative spine stereotactic body radiotherapy. Al-Omair, A., Masucci, L., Masson-Cote, L., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5415159/

Spine Stereotactic Body Radiotherapy: Indications ... Spine SBRT is a highly effective treatment that is capable of delivering ablative doses to the target while sparing the critical organs-at-risk.

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1879850025002206

Long-Term Outcomes After Reirradiation With Spine ... Stereotactic body radiation therapy (SBRT) for spinal metastases is a safe, effective, and cost-effective treatment. As cancer incidence and ...

4. journals.lww.com journals.lww.com/neurosurgery/abstract/9900/repeat_stereotactic_body_radiation_therapy_for.1887.aspx

Repeat Stereotactic Body Radiation Therapy for Spinal... This study supplements previous studies and is one of the largest to report outcomes for a salvage repeat course of spine SBRT after same ...

5. academic.oup.com academic.oup.com/neuro-oncology/article/26/Supplement_1/S76/7618752

Stereotactic body radiation therapy for spinal metastases In this review, we highlight the indications and controversies of SBRT along with new surgical techniques for the treatment of spinal metastases.

6. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00155-0/fulltext

Oncologic and Functional Outcomes After Stereotactic ... One hundred forty-three patients were included. The cumulative incidence of local recurrence was 5.1%, 7.5%, and 14.1% at 6, 12, and 24 months, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11999723/

Five-Year Outcomes of High-Dose Single-Fraction Spinal ... This is the first study reporting the long-term tumor control and toxicity profiles after high-dose single-fraction spinal SRS.