Spine Radiosurgery for Cancer

Overseen By Amol J. Ghia, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Lymphoma, Myeloma, 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 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn whether delivering spine radiosurgery in a single large dose is better than delivering spine radiosurgery over 3 smaller doses. Researchers also want to learn about the effects of a single dose on participant's symptoms, pain, and quality-of-life.

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 Spine Radiosurgery for Cancer?

Research shows that stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) are effective treatments for spinal metastases, which are cancerous growths that spread to the spine. These treatments have been shown to work well in different situations, including as a first treatment, after surgery, and even for tumors that are usually hard to treat with radiation. ^{1 2 3 4 5}

Is spine radiosurgery safe for humans?

Spine radiosurgery, also known as stereotactic body radiotherapy (SBRT) or stereotactic radiosurgery (SRS), is generally considered safe for treating spinal tumors, with complications being rare. The risk of myelopathy (spinal cord damage) is estimated to be very low, affecting only about 0.4% of patients. ^{4 6 7 8 9}

How is spine radiosurgery different from other treatments for spinal metastases?

Spine radiosurgery (also known as stereotactic body radiotherapy, SBRT) is unique because it delivers high-dose radiation precisely to spinal tumors, allowing for effective tumor and pain control while minimizing damage to surrounding healthy tissue. This advanced technique is particularly beneficial for treating tumors near the spinal cord, where conventional radiotherapy may not be feasible due to the risk of damaging the spinal cord. ^{4 10 11 12 13}

Research Team

Amol J. Ghia

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with solid tumor cancers that have spread to the spine and were previously treated with radiation. They must be able to lie flat, have a life expectancy over 6 months, and agree to use contraception. Excluded are pregnant women, those who can't undergo MRI, or had high-dose spinal radiation within 6 months.

Inclusion Criteria

I have had surgery or laser treatment before.

I am eligible regardless of my gender, race, or ethnicity.

Life expectancy must be greater than 6 months

Exclusion Criteria

I've had radiation at a specific site that exceeded safe levels for nerve tissue.

I cannot lie flat comfortably for 2 hours.

My cancer is either lymphoma or myeloma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiosurgery

Participants receive spine radiosurgery in either 1 large dose or 3 smaller doses

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at Months 3, 6, 9, 12, 18, 24, and every 6 months thereafter

Treatment Details

Interventions

• Spine Radiosurgery

Trial Overview The study compares two methods of delivering spine radiosurgery for cancer that has spread to the spine: one single large dose versus three smaller doses. It aims to determine which method is more effective at managing symptoms and improving quality of life.

Participant Groups

Group I: Spine Radiosurgery - 1 Dose Experimental Treatment 2 Interventions

Participants receive spine radiosurgery in a single large dose.

Group II: Spine Radiosurgery - 3 Doses Active Control 2 Interventions

Participants receive spine radiosurgery over 3 smaller doses.

Spine Radiosurgery is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Spine SBRT for:

• Vertebral metastases
• Spinal tumors

Approved in United States as Spine SBRT for:

• Vertebral metastases
• Spinal tumors
• Painful vertebral metastases

Approved in Canada as Spine SBRT for:

• Vertebral metastases
• Spinal tumors

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

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 study involving 10 common scenarios in spinal radiosurgery led to the development of consensus guidelines for target volume definitions, which are crucial for effective treatment of spinal metastases.

The guidelines recommend including abnormal marrow signals in the clinical target volume (CTV) to account for potential microscopic tumor spread, while advising against unnecessary expansions in the absence of epidural disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Cox, BW., Spratt, DE., Lovelock, M., 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]

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) for spinal metastases shows high local control rates exceeding 80% at one year, with effective pain management and low toxicity when strict dose constraints are followed.

There is no clear superiority between single and multifraction regimens in terms of local control and pain relief, but hypofractionated treatments may offer advantages in reducing toxicity compared to single-fraction regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation. Huo, M., Sahgal, A., Pryor, D., et al.[2022]

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]

Stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) have advanced significantly, necessitating updated best practices for safety and quality assurance due to their complexity and precision in delivering high doses of radiation.

A team-based approach with trained specialists and a comprehensive quality assurance program is essential for the safe and effective implementation of SRS and SBRT, emphasizing that patient safety is a collective responsibility among all stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. Das, IJ., Dawes, SL., Dominello, MM., et al.[2022]

Postoperative spine stereotactic body radiation therapy (SBRT) shows a high 1-year local control rate of 88.9% and an overall survival rate of 57%, indicating its efficacy in managing spinal tumors after surgery.

The treatment has an acceptably low toxicity profile, with a vertebral compression fracture rate of only 5.6%, making it a safe option for patients with specific conditions such as oligometastatic disease or those with prior spinal irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery for Postoperative Spine Malignancy: A Systematic Review and International Stereotactic Radiosurgery Society Practice Guidelines. Faruqi, S., Chen, H., Fariselli, L., et al.[2022]

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]

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 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]

Stereotactic body radiation therapy (SBRT) is an effective and safe treatment for spinal bone metastasis, enhancing local control and improving patients' quality of life.

Key factors influencing treatment decisions include life expectancy, fracture risk, localization and size of metastases, and nerve compression, highlighting the need for further studies to identify which patients will benefit most from SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Treatment of Spinal Bone Metastasis. Cihan, YB.[2019]

Spine stereotactic body radiotherapy delivers high doses of radiation specifically to spinal metastases, aiming to improve tumor control and alleviate pain more effectively than conventional low-dose palliative radiotherapy.

This review highlights the technical aspects of spine stereotactic body radiotherapy, its clinical outcomes compared to traditional methods, and the potential serious adverse events associated with this treatment that are not present with conventional radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy: a new paradigm in the management of spinal metastases. Husain, ZA., Thibault, I., Letourneau, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. [2022]

3. China pubmed.ncbi.nlm.nih.gov

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

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

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

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

Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation. [2022]

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

Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. [2021]

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

Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. [2022]

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

Stereotactic Radiosurgery for Postoperative Spine Malignancy: A Systematic Review and International Stereotactic Radiosurgery Society Practice Guidelines. [2022]

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

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

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

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

11. England pubmed.ncbi.nlm.nih.gov

Spine radiosurgery for spinal metastases: indications, technique and outcome. [2014]

12. Thailand pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Treatment of Spinal Bone Metastasis. [2019]

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

Stereotactic body radiotherapy: a new paradigm in the management of spinal metastases. [2022]