Spine SbRT for Spinal Metastases

(DESSRT Trial)

Overseen By Rupesh R Kotecha, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baptist Health South Florida

Disqualifiers: Radiosensitive histologies, Non-ambulatory, Spinal instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques. In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.

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 stereotactic body radiotherapy for spinal metastases?

Research shows that stereotactic body radiotherapy (SBRT) is highly effective for treating spinal metastases, with evidence indicating better pain relief and local control compared to traditional radiation therapy. A specific regimen of 24 Gy in 2 fractions has been highlighted for its effectiveness and reduced side effects. ^{1 2 3 4 5}

Is Spine SBRT generally safe for treating spinal metastases?

Research indicates that Spine SBRT is generally considered safe for treating spinal metastases, with studies showing positive outcomes in terms of safety and effectiveness in properly selected patients. ^{1 3 6 7 8}

How is Spine SBRT treatment different from other treatments for spinal metastases?

Spine SBRT (Stereotactic Body Radiotherapy) is unique because it delivers highly focused radiation doses directly to spinal tumors, minimizing damage to surrounding healthy tissue. This precision allows for effective treatment of tumors that are resistant to traditional radiation and can be used in various settings, including after surgery or for re-treatment. ^{1 2 4 6 9}

Research Team

Rupesh R Kotecha, MD

Principal Investigator

Miami Cancer Institute (MCI) at Baptist Health, Inc.

Eligibility Criteria

This trial is for adults with cancer that has spread to their spine. They must have a certain level of pain, be able to perform daily activities with minimal assistance, and not be pregnant or unable to undergo an MRI. Patients should not have rapid neurological decline, severe spinal damage, or tumors too close to the spinal cord.

Inclusion Criteria

I can take care of myself and am up more than 50% of my waking hours.

It has been at least 6 months since my last radiation treatment.

My cancer has spread to my spine at specific levels but is limited in number and area.

Exclusion Criteria

My neurological condition is worsening quickly.

Patients for whom an MRI of the spine is medically contraindicated

I have a spinal fracture causing more than 50% height loss or instability.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spine stereotactic radiosurgery (SSRS) over 5 treatments to deliver high doses of radiation to tumors of the spine using precision techniques

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain relief and quality of life

12 months

Long-term follow-up

Participants are assessed for long-term effects on quality of life and pain response

24 months

Treatment Details

Interventions

• Spine stereotactic body radiotherapy

Trial Overview The study tests a new way of giving spine stereotactic body radiotherapy (SSRS) for metastatic cancer in the spine. Instead of 1-2 high-dose treatments, it will use lower doses over 5 sessions aiming for fewer side effects while maintaining effectiveness.

Participant Groups

Group I: Radiotherapy Experimental Treatment 1 Intervention

Cohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy

Spine stereotactic body radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Spine SBRT for:

• Spinal metastases
• Pain control
• Local tumor control

Approved in United States as Spine SBRT for:

• Spinal metastases
• Pain control
• Local tumor control

Approved in Canada as Spine SBRT for:

• Spinal metastases
• Pain control
• Local tumor control

Approved in Japan as Spine SBRT for:

• Spinal metastases
• Pain control
• Local tumor control

Approved in China as Spine SBRT for:

• Spinal metastases
• Pain control
• Local tumor control

Approved in Switzerland as Spine SBRT for:

• Spinal metastases
• Pain control
• Local tumor control

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

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) 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 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]

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]

A case study of a spinal metastasis from rectal cancer treated with a single dose of 18Gy using Stereotactic Body Radiation Therapy (SBRT) showed excellent local control and pain relief after one year of follow-up.

The results suggest that SBRT is a feasible and safe treatment option for patients with limited metastatic disease, highlighting its potential effectiveness in managing spinal metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for spinal metastases. Lopes, JC., Navarro, A., Solé, JM., et al.[2021]

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]

Stereotactic body radiotherapy (SBRT) is emerging as a promising treatment option for patients with spinal metastases after surgery, offering higher doses of radiation to improve local tumor control.

Early clinical experiences indicate that postoperative SBRT is both safe and effective, potentially enhancing outcomes compared to traditional external beam radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative stereotactic body radiotherapy for spinal metastases. Alghamdi, M., Tseng, CL., Myrehaug, S., et al.[2018]

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]

References

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

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

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

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

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

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

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

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

Stereotactic body radiation therapy for spinal metastases. [2021]

7. England pubmed.ncbi.nlm.nih.gov

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

8. China pubmed.ncbi.nlm.nih.gov

Postoperative stereotactic body radiotherapy for spinal metastases. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Surgical resection of epidural disease improves local control following postoperative spine stereotactic body radiotherapy. [2022]