Radiation for Spine Cancer

Overseen By Hermina Munoz, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stony Brook University

Disqualifiers: Unstable spine, Previous surgery, Radiosensitive tumors

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 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery

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.

What data supports the effectiveness of the treatment SBRT for spine cancer?

Research shows that SBRT (Stereotactic Body Radiation Therapy) is highly effective for treating spinal metastases, improving pain relief and controlling cancer spread better than traditional radiation methods, with fewer repeat treatments needed. ^{1 2 3 4 5}

Is stereotactic body radiation therapy (SBRT) safe for treating spine cancer?

Research shows that stereotactic body radiation therapy (SBRT), also known as stereotactic ablative radiotherapy (SABR), is generally safe for treating spinal metastases, with studies indicating it balances minimizing treatment side effects while being effective. ^{1 5 6 7 8}

How is the treatment SBRT different from other treatments for spine cancer?

SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers high doses of radiation precisely to the tumor in the spine, minimizing damage to surrounding healthy tissue. This precision allows it to be used effectively for spine metastases, even in areas close to the spinal cord, with a low risk of side effects like myelopathy (spinal cord damage). ^{9 10 11 12 13}

Research Team

Kartik M. Mani

Principal Investigator

Stony Brook Cancer Center

Eligibility Criteria

This trial is for patients with solid tumor cancers, excluding brain origin, that have spread to the spine. Participants must have a maximum of 3 affected spinal segments and maintain basic neurological function or minor deficits. They should be evaluated by specialists and have an ECOG Performance Status score between 0-3.

Inclusion Criteria

My muscle strength is mostly normal, at least 4 out of 5, with or without medication.

I have been evaluated by a specialist in cancer radiation and spine surgery.

My spine issue affects up to 3 connected vertebrae.

Exclusion Criteria

I have had surgery or radiation for cancer in my spine.

An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12

My cancer type is known to respond well to radiation therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic body radiation therapy (SBRT) to the spine

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 1, 3, and 6 months

Treatment Details

Interventions

• SBRT

Trial Overview The study tests if stereotactic body radiation therapy (SBRT) can effectively treat aggressive spinal metastases in cancer patients without needing major surgery.

Participant Groups

Group I: SBRT to the spine Experimental Treatment 1 Intervention

SBRT is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in European Union as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors
• Bone metastases

Approved in Canada as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Japan as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials

486

Recruited

92,500+

Findings from Research

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) 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]

In a Phase I/II study involving 63 cancer patients, stereotactic body radiotherapy (SBRT) demonstrated a high safety profile with no observed cases of neuropathy or myelopathy during a median follow-up of 21.3 months.

SBRT was effective in controlling spinal metastatic tumors, achieving an 84% tumor progression-free rate at one year, although failures primarily occurred due to recurrence in adjacent bone or the epidural space.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II study of stereotactic body radiotherapy for spinal metastasis and its pattern of failure. Chang, EL., Shiu, AS., Mendel, E., et al.[2022]

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]

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 ablative radiotherapy (SABR) demonstrated a high local control rate of 91.2% for skeletal metastases in a study of 22 patients, with a median follow-up of 15.6 months, indicating its effectiveness in managing oligometastatic and oligoprogressive diseases.

The treatment resulted in significant pain control for two-thirds of symptomatic patients, with limited toxicities reported, including only two vertebral fractures and one case of grade 3 esophagitis, suggesting that SABR is a safe option for patients with skeletal metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of stereotactic ablative radiotherapy in oligometastatic & oligoprogressive skeletal metastases: Results and pattern of failure. Kam, TY., Chan, OSH., Hung, AWM., et al.[2019]

Stereotactic body radiotherapy (SBRT) demonstrated an 83.3% local control rate for spinal metastases at one year, indicating it is an effective treatment option for managing these tumors.

The treatment was associated with low toxicity, as no cases of Grade 4 toxicity were reported, and only one patient experienced Grade 3 toxicity, suggesting SBRT is safe even for patients with prior radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy in spinal metastases. Ahmed, KA., Stauder, MC., Miller, RC., et al.[2022]

In a study of 53 patients with lung tumors ≥5 cm treated with SABR, 30% experienced severe toxicity (grade ≥3), highlighting the need for improved treatment planning to reduce risks.

Using a knowledge-based planning model, researchers found that nearly 50% of the treatment plans for patients with severe toxicity could have been improved, particularly in terms of lung dose exposure, suggesting that model-based quality assurance could enhance safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge-Based Planning for Identifying High-Risk Stereotactic Ablative Radiation Therapy Treatment Plans for Lung Tumors Larger Than 5 cm. Hof, SV., Delaney, AR., Tekatli, H., et al.[2019]

In a study of 60 patients treated with spine SBRT, the 2-year local control rate was 70.6%, indicating that this treatment is effective for managing spine metastasis without significant toxicity.

Delaying SBRT for at least 6 months after the diagnosis of spinal lesions improved local control rates to 88%, suggesting that timing of treatment may enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of spinal SBRT. Is it important to select the treatment time? Pérez-Montero, H., Godino, O., Lozano, A., et al.[2022]

In a study of 46 patients treated with spine stereotactic body radiation therapy (SBRT), no cases of myelopathy were reported, suggesting that current guidelines may overestimate the risk of this complication, even when exceeding recommended dose limits.

The most common side effects observed were pain and nausea, with specific dose thresholds identified: a maximum dose to the spinal cord of 38.5 Gy and to the thecal sac of 67.7 Gy, indicating that higher doses may be tolerated without severe toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric analysis of varying cord planning organ at risk volume in spine stereotactic body radiation therapy. Owen, D., Mayo, CS., Song, L., et al.[2020]

In a study involving 23 patients with metastatic spinal lesions, the Klarity SBRT patient immobilization system showed larger initial setup discrepancies compared to the BodyFIX system, particularly in vertical and lateral alignment, indicating a need for careful consideration in patient positioning.

Despite the initial alignment differences, the Klarity system achieved similar setup efficiency and stability as the BodyFIX system, suggesting it could be a viable alternative for spine SBRT with potential workflow advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of setup accuracy and efficiency between the Klarity system and BodyFIX system for spine stereotactic body radiation therapy. Quan, E., Krafft, SP., Briere, TM., et al.[2022]

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]

In a study of 149 patients with spinal metastases, spinal stereotactic body radiation therapy (SBRT) significantly increased the number of patients reporting no pain from bone metastases from 26% before treatment to 54% six months after, indicating its efficacy in pain management.

SBRT not only reduced pain levels and opioid use among patients but also demonstrated a high progression-free survival rate of 80.5% at one year, with minimal side effects and no severe late spinal cord toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for management of spinal metastases in patients without spinal cord compression: a phase 1-2 trial. Wang, XS., Rhines, LD., Shiu, AS., et al.[2022]

References

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

Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy: an emerging treatment for spinal metastases. [2019]

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

Phase I/II study of stereotactic body radiotherapy for spinal metastasis and its pattern of failure. [2022]

4. China pubmed.ncbi.nlm.nih.gov

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

5. Poland pubmed.ncbi.nlm.nih.gov

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

6. Australia pubmed.ncbi.nlm.nih.gov

Utilization of stereotactic ablative radiotherapy in oligometastatic & oligoprogressive skeletal metastases: Results and pattern of failure. [2019]

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

Stereotactic body radiation therapy in spinal metastases. [2022]

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

Knowledge-Based Planning for Identifying High-Risk Stereotactic Ablative Radiation Therapy Treatment Plans for Lung Tumors Larger Than 5 cm. [2019]

9. Italy pubmed.ncbi.nlm.nih.gov

Long-term outcomes of spinal SBRT. Is it important to select the treatment time? [2022]

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

Dosimetric analysis of varying cord planning organ at risk volume in spine stereotactic body radiation therapy. [2020]

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

Comparison of setup accuracy and efficiency between the Klarity system and BodyFIX system for spine stereotactic body radiation therapy. [2022]

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

Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for management of spinal metastases in patients without spinal cord compression: a phase 1-2 trial. [2022]