Proton SBRT for Spinal Cancer

Overseen By Ryan Manuel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Infection, Heart failure, Angina, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of radiation therapy called Proton SBRT (Stereotactic Body Radiation Therapy) for individuals with spinal cancer that standard methods cannot effectively treat. The goal is to determine if this treatment can better target and manage complex cases where usual care proves insufficient. It is intended for those with non-blood-related cancer that has spread to the spine and for whom standard photon therapy is not an option. Participants should face specific challenges, such as extensive disease near the spine or previous radiation treatments. For those meeting these criteria, this trial could offer a promising alternative. As an unphased trial, it provides a unique opportunity for patients to access cutting-edge treatment options that may not be available elsewhere.

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 proton SBRT is safe for spinal cancer?

Research has shown that proton stereotactic body radiotherapy (SBRT) might safely treat cancer that has spread to the spine. One study found that SBRT is a safe treatment for spine cancer and may relieve pain better than traditional methods.

Another study compared proton and photon SBRT plans and suggested that proton SBRT could be promising for treating spine cancer, indicating it might be well-tolerated by patients. Additionally, a report showed that after SBRT treatment, 35% of patients experienced complete relief from spinal pain.

These findings suggest that proton SBRT is generally well-tolerated, with some patients experiencing significant pain relief. However, as with any treatment, individual experiences may vary, and potential side effects should be discussed with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which often involves photon SBRT (Stereotactic Body Radiation Therapy) for spinal cancer, Spinal Proton SBRT uses proton beams. Proton therapy is unique because it allows for more precise targeting of cancer cells, minimizing damage to surrounding healthy tissue. This precision is particularly important for complex spinal lesions that are challenging to treat with traditional methods. Researchers are excited about Proton SBRT because it has the potential to reduce side effects and improve outcomes for patients with spinal metastasis.

What evidence suggests that Spinal Proton SBRT might be an effective treatment for spinal cancer?

Research has shown that proton stereotactic body radiotherapy (SBRT) could effectively treat cancer that has spread to the spine, especially when standard treatments fail. In this trial, participants will receive Spinal Proton SBRT, which researchers are studying for its potential to better control complex spinal tumors compared to traditional methods. Data indicates that the cancer remains localized in 80% to 96% of cases after one year. Additionally, proton SBRT has been associated with significant pain relief, with 35% of patients reporting no spinal pain three months after treatment. These findings suggest that proton SBRT could be a strong option for patients with challenging spinal cancer cases. ^{3 6 7 8 9}

Who Is on the Research Team?

Kristin Redmond, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults with non-blood-related cancer that has spread to the spine, where standard radiation therapy isn't suitable due to complex lesions. Participants need proof of such cancer, spinal metastasis visible on MRI, and must be in a condition allowing daily activities (ECOG ≤2). They should agree to use contraception and understand the study's experimental nature.

Inclusion Criteria

I am using effective birth control because I can have children and am undergoing radiation therapy.

I understand this study is experimental and I have signed the consent form.

My spinal tumor has grown into the epidural space.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive proton stereotactic body radiotherapy (SBRT) for spinal metastasis

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of neurologic toxicity, local control rate, and quality of life

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Proton SBRT

Trial Overview The study tests proton SBRT, an advanced type of targeted radiotherapy for spinal metastasis. It aims at treating patients whose conditions can't be effectively managed by conventional photon SBRT. The goal is to see if this method can better target tumors while sparing healthy tissue.

How Is the Trial Designed?

Group I: Spinal Proton SBRT Experimental Treatment 1 Intervention

Proton SBRT for nonhematologic spinal metastasis in patients with complex lesions that are unable to be effectively treated with standard of care photon SBRT.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Sibley Foundation

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

In a Phase I/II study involving 63 cancer patients, stereotactic body radiotherapy (SBRT) demonstrated a high safety profile with no observed cases of neuropathy or myelopathy during a median follow-up of 21.3 months.

SBRT was effective in controlling spinal metastatic tumors, achieving an 84% tumor progression-free rate at one year, although failures primarily occurred due to recurrence in adjacent bone or the epidural space.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II study of stereotactic body radiotherapy for spinal metastasis and its pattern of failure. Chang, EL., Shiu, AS., Mendel, E., et al.[2022]

In a phase 1/2 study involving 61 patients with spinal metastases, single-fraction stereotactic body radiotherapy (SBRT) demonstrated a high local control rate of 88% and an overall survival rate of 64% over an 18-month follow-up period, indicating its efficacy as a treatment option.

While SBRT was generally safe, with only two patients experiencing significant radiation-related adverse events, the study suggests the need for further research to identify factors that could predict spinal cord toxicity, ensuring patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2 trial of single-session stereotactic body radiotherapy for previously unirradiated spinal metastases. Garg, AK., Shiu, AS., Yang, J., et al.[2022]

This study involves 120 patients with spinal bone metastases receiving stereotactic body radiation therapy (SBRT) with different fractionation schedules to evaluate local tumor control and safety.

The trial aims to compare the effectiveness of SBRT with and without simultaneous integrated boost (SIB) in improving tumor targeting and patient outcomes, including pain relief and quality of life, over a follow-up period of three to six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial. Sprave, T., Welte, SE., Bruckner, T., et al.[2023]

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]

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]

In a study of 56 patients receiving proton beam therapy (PBT) for various cancers, no severe (Grade 4 or 5) toxicities were observed, indicating a high safety profile for this treatment method.

The most common adverse effect was Grade 3 hematologic toxicity in 12.5% of patients, which was unlikely related to PBT, suggesting that while the therapy is generally safe, further research is needed to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study to evaluate the safety of the world-first spot-scanning dedicated, small 360-degree gantry, synchrotron-based proton beam therapy system. Nishioka, K., Prayongrat, A., Ono, K., et al.[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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625027348

Outcomes Associated with Proton Spine Stereotactic Body ... Little is known about the long-term outcomes of patients with spinal metastases treated with proton stereotactic body radiation therapy (pSBRT) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932874/

Comparison of Proton Versus Photon SBRT for Treatment ... Overall, the data presented in this manuscript suggest that proton SBRT may be promising in the treatment of spinal metastases for the following reasons: (1) ...

3. practicalradonc.org practicalradonc.org/article/S1879-8500(25)00220-6/fulltext

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 ...

4. cancer.gov cancer.gov/news-events/cancer-currents-blog/2020/radiation-sbrt-painful-spinal-metastases

Radiation to Treat Painful Spinal Metastases - NCI Three months after treatment, 35% of people in the SBRT group reported that their spinal pain was gone, compared with 14% of the people who ...

5. 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40144347/

Comparison of Proton Versus Photon SBRT for Treatment ... To better understand the safety of proton SBRT for spinal metastasis, this dosimetric analysis compares plans using photon robotic techniques ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S233151802500006X

Comparison of Proton Versus Photon SBRT for Treatment ... Overall, the data presented in this manuscript suggest that proton SBRT may be promising in the treatment of spinal metastases for the following reasons: (1) ...

8. academic.oup.com academic.oup.com/neuro-oncology/article/26/Supplement_1/S76/7618752

Stereotactic body radiation therapy for spinal metastases In this review, we highlight the indications and controversies of SBRT along with new surgical techniques for the treatment of spinal metastases.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37739318/

Stereotactic body radiation therapy versus conventional ... Conclusion: SBRT is a safe treatment option for spine metastases. It may provide better complete pain response compared to cEBRT.