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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for individuals with spine tumors. Instead of administering a high dose in one or two treatments, this approach distributes the radiation over five sessions. The goal is to determine if this method reduces side effects while maintaining effectiveness. Individuals with spine metastasis (cancer that has spread to the spine) who experience significant pain without medication might be suitable candidates. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that this spine stereotactic radiosurgery technique is safe?

Research has shown that spine stereotactic body radiotherapy (SBRT) is generally safe and effective for treating cancer that has spread to the spine. Studies have found that SBRT provides good pain relief and helps control the disease with few side effects. Reports indicate that patients tolerate SBRT well, and it offers lasting benefits for managing pain and tumors.

Overall, SBRT has a good safety record, with most people not experiencing serious side effects. Spreading out the treatments, as suggested by this study, might further reduce side effects. This is encouraging for those considering joining a trial using this method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spine stereotactic body radiotherapy (SbRT) for spinal metastases because it offers a highly precise way to target tumors in the spine with radiation. Unlike traditional radiation therapy, which can affect a broader area and potentially harm surrounding healthy tissue, SbRT delivers focused, high-dose radiation directly to the tumor. This precision not only helps protect healthy tissue but also may reduce treatment times and side effects, improving patient comfort and outcomes.

What evidence suggests that this spine stereotactic body radiotherapy technique is effective for spinal metastases?

Research has shown that spine stereotactic body radiotherapy (SBRT) effectively treats cancer that has spread to the spine. Studies have found that SBRT controls the cancer well, with success rates between 80% and 96% after one year. Most patients experience pain relief, often within two weeks of starting treatment. This trial includes two cohorts: one for participants without prior radiotherapy and another for those who have received it. SBRT is considered safe and effective, even for those with previous radiation therapy. Administering the radiation over several sessions, rather than just one or two, may reduce side effects while still effectively managing the cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Rupesh R Kotecha, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

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

My spinal cord has a safe distance from my epidural lesion.

Exclusion Criteria

My neurological condition is worsening quickly.

Patients for whom an MRI of the spine is medically contraindicated

My cancer type responds well to radiation therapy.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

Citations

1. redjournal.org redjournal.org/article/S0360-3016(20)34741-6/pdf

Long-Term Results of Dose-Intensified Fractionated ... Stereotactic body radiation therapy for spinal metastases was observed to achieve pain relief in 80% to 100% of patients at a median time of 2 weeks4 together ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5415159/

Spine Stereotactic Body Radiotherapy: Indications ... Local control ranges from 80% to 96% at 1 year, and pain response is generally achieved in the majority of patients although high-quality data is lacking. Table ...

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)89863-2/fulltext

Efficacy and safety of SBRT for spine metastases The currently available data including 5 randomized trials of SBRT for spine metastases confirm that spine SBRT is an effective therapy for ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1879850025002206

Long-Term Outcomes After Reirradiation With Spine ... Stereotactic body radiation therapy (SBRT) for spinal metastases is a safe, effective, and cost-effective treatment. As cancer incidence and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352806/

Stereotactic Radiosurgery in Metastatic Spine Disease—A ... This study highlights SRS as a safe and effective technique for managing spinal metastases. It offers good pain control and tumor control with minimal ...

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

Oncologic and Functional Outcomes After Stereotactic ... Pain response at 3 and 6 months post-SBRT was complete in 45.4% and 55.7%, partial in 26.9% and 13.1%, stable in 24.1% and 27.9%, and worse in ...