Radiation Therapy for Spinal Cancer

Overseen By Daniel Spratt, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

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

240 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.

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.

What data supports the idea that Radiation Therapy for Spinal Cancer is an effective treatment?

The available research shows that Stereotactic Body Radiation Therapy (SBRT) can be more effective than conventional radiation therapy for spinal cancer. One study found that SBRT allows for higher doses of radiation, which can improve local control of the cancer, meaning it helps keep the cancer from growing back in the treated area. Another study compared different radiation methods and suggested that SBRT might be better at sparing healthy tissue, which can reduce complications when combined with surgery. Overall, these findings suggest that SBRT could be a more effective option for treating spinal cancer compared to traditional methods. ^{1 2 3 4 5}

What safety data exists for radiation therapy in spinal cancer treatment?

The safety data for radiation therapy in spinal cancer treatment includes findings that stereotactic body radiation therapy (SBRT) can provide improved local control and palliation of disease compared to conventional external beam radiation therapy (EBRT). However, SBRT is associated with an increased risk of vertebral body fractures. Studies have compared fracture rates between SBRT and EBRT, and have also evaluated the impact of radiation dose on surgical areas to minimize wound complications. Additionally, SBRT has been shown to be effective in retreatment scenarios for spinal metastasis, offering potential benefits over initial EBRT treatments. ^{1 2 5 6 7}

Is the treatment Radiation Therapy for Spinal Cancer promising?

Yes, the treatment is promising. Stereotactic Body Radiation Therapy (SBRT) can deliver high doses of radiation precisely to spinal tumors, improving local control and reducing the need for retreatment. It also helps manage pain effectively while minimizing damage to surrounding healthy tissues. ^{1 2 4 6 8}

Research Team

Daniel Spratt, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

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

I am over 18 years old.

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

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.

Treatment Details

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.

Participant Groups

Group I: Standard dose SBRT Experimental Treatment 1 Intervention

Participants will undergo standard dose Stereotactic Body Radiation Therapy

Group II: High dose SBRT Experimental Treatment 1 Intervention

Participants will undergo high dose Stereotactic Body Radiation Therapy

Group III: Conventional EBRT Experimental Treatment 1 Intervention

Participants will undergo External Beam Radiation Therapy

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?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

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]

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]

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]

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]

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]

References

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

Mature Imaging-Based Outcomes Supporting Local Control for Complex Reirradiation Salvage Spine Stereotactic Body Radiotherapy. [2021]

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

Sparing the surgical area with stereotactic body radiotherapy for combined treatment of spinal metastases: a treatment planning study. [2019]

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

Trends in Radiation Therapy for Bone Metastases, 2015 to 2017: Choosing Wisely in the Era of Complex Radiation. [2022]

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

Clinical Outcomes of Dose-Escalated Hypofractionated External Beam Radiation Therapy (5 Gy × 5 Fractions) for Spine Metastasis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Local tumor control after retreatment of spinal metastasis using stereotactic body radiotherapy; comparison with initial treatment group. [2022]

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

Vertebral body fracture rates after stereotactic body radiation therapy compared with external-beam radiation therapy for metastatic spine tumors. [2023]

7. Netherlands 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. [2022]

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

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