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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a single large dose of spine radiosurgery (a precise form of radiation therapy) is more effective than three smaller doses for individuals with cancer that has spread to the spine. Researchers aim to assess how each approach impacts symptoms, pain levels, and quality of life. The trial suits those with solid tumors that have metastasized to the spine and who have previously received radiation treatment in that area. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in cancer care.

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 radiosurgery is generally safe for treating cancer that has spread to the spine. Studies indicate it has a good safety record, meaning it usually causes few side effects. One study found that this treatment effectively controls pain and the disease while being well-tolerated by patients.

However, a moderate risk of side effects may appear long after treatment. This is important to consider when deciding to join a trial. Overall, spine radiosurgery is considered a safe option for treating spinal tumors, with positive safety results reported in various studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about spine radiosurgery for cancer because it offers a more targeted approach to treating spinal tumors compared to traditional radiation therapy. Unlike conventional treatments that might take several weeks of daily sessions, this radiosurgery can be delivered in either a single large dose or three smaller doses, potentially reducing the treatment time and minimizing exposure to surrounding healthy tissue. This precision could lead to fewer side effects and a quicker recovery, making it an appealing option for patients and healthcare providers alike.

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

Research has shown that spine radiosurgery effectively treats cancer that has spread to the spine. It targets cancer cells with strong doses while protecting nearby healthy tissue. This trial will compare two approaches: one group will receive spine radiosurgery over three smaller doses, while another group will receive it in a single large dose. Many patients can control the cancer's spread, with 84.7% achieving control at six months and 74.7% at one year. Additionally, many patients experience significant pain relief; some studies reported complete pain relief in nearly half of the patients at three and six months after treatment. Overall, spine radiosurgery helps manage spine cancer symptoms and improves quality of life. ^{2 3 4 6 7}

Who Is on the Research Team?

Amol J. Ghia

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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) 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]

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]

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]

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]

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]

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

Spine SBRT yields greater complete/partial pain response rates than expected. •. Spine SBRT is associated with high rates of local control.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6460302/

Outcomes in the radiosurgical management of metastatic ...

Radiologic local control was achieved in 84.7% of patients at 6 months and in 74.7% of patients at 1 year. Local control was found to be affected by the Spinal ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1879850025002206

Long-Term Outcomes After Reirradiation With Spine ...

At 1 year, overall survival was 61% with a cumulative incidence of local failure at 12% and vertebral compression fracture at 9% considering ...

5.

advancesradonc.org

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

Oncologic and Functional Outcomes After Stereotactic ...

Five of 13 patients (38.4%) with initial Bilsky grade 3 improved to grade 1 to 2. Pain response at 3 and 6 months post-SBRT was complete in 45.4 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7453968/

Radiation Dose–Response for Late Toxicity - PMC

Stereotactic radiosurgery for primary treatment and reirradiation of spinal metastases is associated with a moderate risk of late toxicity with 10-year follow- ...

7.

withpower.com

withpower.com/trial/spine-sbrt-for-spinal-metastases-2dafe

Spine SbRT for Spinal Metastases (DESSRT Trial)

Research indicates that Spine SBRT is generally considered safe for treating spinal metastases, with studies showing positive outcomes in terms of safety and ...