Radiation Therapy for Spinal Cancer

(SPORTSMEN Trial)

Recruiting at 2 trial locations

Overseen By Lead Onco Nurse

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Oklahoma

Must not be taking: Investigational agents

Disqualifiers: Pregnancy, Uncontrolled illness, Previous radiation, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three types of radiation therapy for cancer that has spread to the spine. It compares traditional External Beam Radiation Therapy (EBRT) with two doses of Stereotactic Body Radiation Therapy (SBRT), a newer, highly targeted radiation method, to determine which is most effective. The trial seeks participants diagnosed with cancer that has spread to the spine who have not received prior radiation treatments for it. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not change your pain medications on the first day of SBRT.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) for spine cancer is safe. Studies indicate it effectively reduces pain and controls the disease, with patients generally tolerating it well. One study found that many patients experienced significant pain relief within 3 to 6 months after treatment. Another study reported that side effects, such as vertebral compression fractures, were rare, occurring in about 9% of patients after one year.

External Beam Radiation Therapy (EBRT) is also considered safe. It is a common treatment for cancer that has spread to the spine and is generally well-tolerated, with most side effects being mild and manageable.

Both treatments are standard for spinal cancer and have shown positive results in terms of safety and effectiveness, making them reliable options for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for spinal cancer because they offer targeted radiation options that could improve precision and reduce damage to surrounding healthy tissues. Unlike conventional External Beam Radiation Therapy (EBRT), which delivers radiation to a broader area, Spine Radiosurgery or Stereotactic Body Radiation Therapy (SBRT) focuses high doses of radiation more precisely at the cancer site. This precision allows for higher doses to be administered in fewer sessions, which could mean quicker treatment times and potentially fewer side effects. The trial includes both high-dose and standard-dose SBRT, offering insights into the effectiveness and safety of different radiation intensities in treating spinal cancer.

What evidence suggests that this trial's radiation therapies could be effective for spinal cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) effectively treats spinal cancer. Studies report that 46% to 92% of patients experience a complete reduction in cancer signs. SBRT also helps prevent further cancer spread. Additionally, 45% to 56% of patients achieve full pain relief within 3 to 6 months after treatment. In this trial, participants may receive either a high dose or standard dose of SBRT. External Beam Radiation Therapy (EBRT) is another treatment option, targeting cancer from outside the body. SBRT allows for more precise targeting and higher radiation doses. These findings suggest that both treatments can be effective, with SBRT showing promising results in precise and powerful cancer treatment. ^{1 2 3 4 5}

Who Is on the Research Team?

Shearwood McClelland III, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

Adults over 18 with cancer that has spread to the spine, expected to live at least 3 more months, and experiencing moderate pain. They must not have had previous treatments for these spinal tumors or be planning to change pain meds during the trial. Pregnant women, those with severe illnesses or instability in their spines are excluded.

Inclusion Criteria

Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.

I am over 18 years old.

My worst pain level is less than 2 on a scale of 0 to 10.

Exclusion Criteria

The origin of my cancer is unknown.

I am not considered a candidate for SBRT according to my radiation oncologist.

I have nerve issues due to cancer in my spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EBRT, standard dose SBRT, or high dose SBRT for metastatic spine cancer

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including local control and vertebral compression fracture rate

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional External Beam Radiation Therapy Dose (EBRT)
• Spine Radiosurgery/Stereotactic Body Radiation Therapy High Dose
• Spine Radiosurgery/Stereotactic Body Radiation Therapy Standard Dose

Trial Overview The study compares three radiation therapies for patients with metastatic spine cancer: high-dose SBRT (precise high-dose radiation), standard-dose SBRT, and conventional EBRT (targeted beams from outside). Participants will be randomly assigned one of these treatments.

How Is the Trial Designed?

Group I: Standard SBRT Experimental Treatment 1 Intervention

Participants will undergo standard dose Stereotactic Body Radiation Therapy as part of standard of care.

Group II: High Dose SBRT (SOC) Experimental Treatment 1 Intervention

Participants will undergo high dose Stereotactic Body Radiation Therapy as part of standard of care.

Group III: Conventional EBRT (SOC) Experimental Treatment 1 Intervention

Participants will undergo External Beam Radiation Therapy as part of standard of care.

Conventional External Beam Radiation Therapy Dose (EBRT) is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as External Beam Radiation Therapy for:

• Cancer treatment
• Palliative care
• Symptomatic relief

Approved in United States as External Beam Radiation Therapy for:

• Cancer treatment
• Palliative care
• Symptomatic relief
• Spinal metastases

Approved in Canada as External Beam Radiation Therapy for:

• Cancer treatment
• Palliative care
• Symptomatic relief

Approved in Japan as External Beam Radiation Therapy for:

• Cancer treatment
• Palliative care
• Symptomatic relief

Approved in China as External Beam Radiation Therapy for:

• Cancer treatment
• Palliative care
• Symptomatic relief

Approved in Switzerland as External Beam Radiation Therapy for:

• Cancer treatment
• Palliative care
• Symptomatic relief

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

Spinal stereotactic body radiotherapy (SBRT) shows promising efficacy for patients with spinal metastases who have previously undergone conventional external beam radiation therapy (cEBRT), with a low local failure rate of 18% and actuarial rates of 7%, 14%, and 19% at 6, 12, and 24 months, respectively.

The treatment is considered safe, with a low risk of vertebral compression fractures (4%) and no observed cases of radiation myelopathy, making it a viable option for patients with extensive prior radiation history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mature Imaging-Based Outcomes Supporting Local Control for Complex Reirradiation Salvage Spine Stereotactic Body Radiotherapy. Detsky, JS., Nguyen, TK., Lee, Y., et al.[2021]

From 2015 to 2017, short-course external-beam radiation therapy (EBRT) for bone metastases increased, while long-course EBRT decreased by 8%, indicating a shift towards more efficient treatment options.

Stereotactic body radiation therapy (SBRT) usage rose to 7% of treatments, showing a growing acceptance of complex techniques, although expenditures for these advanced modalities decreased, suggesting improved cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in Radiation Therapy for Bone Metastases, 2015 to 2017: Choosing Wisely in the Era of Complex Radiation. Santos, PMG., Lapen, K., Zhang, Z., et al.[2022]

In a study of 75 patients with spinal metastasis treated with external beam radiation therapy (EBRT) to 25 Gy in 5 fractions, 75.7% experienced partial or complete pain relief for a median duration of 6 months, indicating effective palliative care.

The treatment demonstrated a low toxicity profile, with no cases of treatment-related myelopathy and only mild side effects like fatigue and pain flare, making it a safe option for patients with spinal metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Dose-Escalated Hypofractionated External Beam Radiation Therapy (5 Gy × 5 Fractions) for Spine Metastasis. Shin, JY., Mathis, NJ., Wijetunga, NA., et al.[2022]

Stereotactic body radiotherapy (SBRT) for retreatment of spinal metastases showed high local control rates of 96% at six months and 81% at twelve months, indicating its efficacy in managing recurrent spinal tumors.

Importantly, there were no cases of radiation myelopathy reported, suggesting that SBRT can be safely administered even in patients with previous radiation therapy, with a mean spinal cord dose that remained within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local tumor control after retreatment of spinal metastasis using stereotactic body radiotherapy; comparison with initial treatment group. Chang, UK., Cho, WI., Kim, MS., 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]

Using stereotactic body radiotherapy (SBRT) significantly reduces the radiation dose in the surgical area compared to conventional external beam radiotherapy (EBRT), with median doses of 2.6Gy for SBRT with active sparing versus 6.5Gy for EBRT.

Active sparing during SBRT further minimizes radiation exposure in the surgical area without affecting the treatment dose to spinal metastases or surrounding organs, highlighting its potential for safer surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sparing the surgical area with stereotactic body radiotherapy for combined treatment of spinal metastases: a treatment planning study. Versteeg, AL., Hes, J., van der Velden, JM., et al.[2019]

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 radiation therapy (SBRT) significantly improved complete pain response rates at 3 months for patients with painful bone metastases compared to conventional external beam radiation therapy (cEBRT), with a high certainty of evidence from six randomized controlled trials.

SBRT also reduced local progression rates, indicating it may be more effective in managing bone metastases, although it was associated with increased pain flare rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy versus conventional external beam radiation therapy for painful bone metastases: A systematic review and meta-analysis of randomized trials. Lee, CC., Soon, YY., Cheo, T., et al.[2022]

Citations

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

Spine Stereotactic Body Radiotherapy: Indications ... On the other hand, spine SBRT literature has reported complete response rates as high as 46% to 92%. Therefore, the data does suggest that while cEBRT may be ...

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

Efficacy and safety of SBRT for spine metastases Spine SBRT is associated with high rates of local control. •. ∼10 % get post-SBRT vertebral compression fractures with < 2 % needing surgery.

3. 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 ...

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

Outcomes in the radiosurgical management of metastatic ... When stratified by upfront spinal surgery before SBRT, of those who underwent surgery (n = 18), 38.9% of patients (n = 7) showed a decrease in pain. Of those ...

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

Long-Term Outcomes After Reirradiation With Spine ... We report a retrospective, single-institutional experience of 107 lesions treated in 91 patients. Of these, 88 (72%) lesions were initially ...