Spine Radiosurgery for Spinal Cancer Spread

Overseen By Kelly Huang

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

Trial Summary

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 Multi-fraction spine SRS, Fractionated Stereotactic Radiosurgery, Multi-fraction SRS, Stereotactic Body Radiation Therapy (SBRT), Single-fraction spine SRS, Stereotactic Body Radiation Therapy (SBRT), Stereotactic Ablative Radiotherapy (SABR), CyberKnife, Gamma Knife for spinal cancer spread?

Research shows that Stereotactic Body Radiation Therapy (SBRT) is effective for treating spinal metastases, improving pain relief and local control compared to traditional radiation methods. Studies indicate that specific dosing schedules, like 24 Gy in 2 fractions, offer a good balance between effectiveness and minimizing side effects. ^{1 2 3 4 5}

Is spine radiosurgery safe for treating spinal cancer spread?

Spine radiosurgery, including techniques like SRS and SBRT, is generally considered safe for treating spinal tumors, with a low risk of complications such as myelopathy (spinal cord damage) occurring in about 0.4% of patients. However, there is an increased risk of vertebral body fractures compared to traditional radiation therapy. ^{2 6 7 8 9}

How is the treatment for spinal cancer spread using spine radiosurgery different from other treatments?

This treatment, known as Stereotactic Body Radiation Therapy (SBRT), is unique because it delivers high doses of radiation precisely to spinal tumors in fewer sessions, which can improve pain relief and control the cancer better than traditional radiation therapy. It is particularly beneficial for patients who cannot undergo surgery or have already received radiation, as it minimizes damage to surrounding healthy tissue. ^{1 2 3 4 10}

What is the purpose of this trial?

The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.

Research Team

Erqi Pollom, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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 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]

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]

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]

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]

References

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

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

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

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

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Dose-Escalated 2-Fraction Spine Stereotactic Body Radiation Therapy: 28 Gy Versus 24 Gy in 2 Daily Fractions. [2023]

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

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

7. France pubmed.ncbi.nlm.nih.gov

[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. [2018]

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

Patient outcomes and tumor control in single-fraction versus hypofractionated stereotactic body radiation therapy for spinal metastases. [2023]

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

Vertebral body fracture rates after stereotactic body radiation therapy compared with external-beam radiation therapy for metastatic spine tumors. [2023]

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

Stereotactic body radiotherapy reirradiation for recurrent epidural spinal metastases. [2011]