12 Participants Needed

Proton SBRT for Spinal Cancer

KR
RM
Overseen ByRyan Manuel
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is a single-arm pilot study of proton stereotactic body radiotherapy (SBRT) for nonhematologic spinal metastasis in patients with complex lesions that are unable to be effectively treated with standard of care photon SBRT defined as inability to develop a photon SBRT plan that achieves adequate coverage (≥80% planning treatment volume (PTV) coverage)) with a prescription dose of 30 Gy in 5 fractions.

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 Spinal Proton SBRT for spinal cancer?

Research shows that stereotactic body radiotherapy (SBRT), a similar treatment, is effective for spinal metastases, improving pain relief and controlling tumor growth better than traditional methods. This suggests that Spinal Proton SBRT could also be effective for spinal cancer.12345

Is Proton SBRT for spinal cancer safe for humans?

Research shows that high-dose proton therapy, including techniques like pencil beam scanning, has been studied for safety in treating various conditions, including spinal tumors. Studies indicate that it is generally safe, with no severe (Grade 4 or 5) treatment-related toxicities observed, although some mild to moderate side effects may occur.12678

How is Spinal Proton SBRT treatment different from other treatments for spinal cancer?

Spinal Proton SBRT is unique because it uses proton beams, which can be more precisely targeted to the tumor, potentially reducing damage to surrounding healthy tissue compared to traditional radiation therapies. This precision may lead to fewer side effects and improved outcomes for patients with spinal cancer.12349

Research Team

KR

Kristin Redmond, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Spinal Proton SBRTExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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.
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.
Phase 1/2 trial of single-session stereotactic body radiotherapy for previously unirradiated spinal metastases.Garg, AK., Shiu, AS., Yang, J., et al.[2022]
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.
Stereotactic body radiotherapy as a primary treatment for spinal metastasis: a single institution experience.Yeung, WME.[2021]

References

Phase I/II study of stereotactic body radiotherapy for spinal metastasis and its pattern of failure. [2022]
Phase 1/2 trial of single-session stereotactic body radiotherapy for previously unirradiated spinal metastases. [2022]
Stereotactic body radiotherapy as a primary treatment for spinal metastasis: a single institution experience. [2021]
Stereotactic body radiotherapy for spine metastases: a review of 24 Gy in 2 daily fractions. [2023]
Stereotactic radiotherapy: an emerging treatment for spinal metastases. [2019]
Long-Term Clinical Safety of High-Dose Proton Radiation Therapy Delivered With Pencil Beam Scanning Technique for Extracranial Chordomas and Chondrosarcomas in Adult Patients: Clinical Evidence of Spinal Cord Tolerance. [2022]
Prospective study to evaluate the safety of the world-first spot-scanning dedicated, small 360-degree gantry, synchrotron-based proton beam therapy system. [2019]
Single and Multifraction Spine Stereotactic Body Radiation Therapy and the Risk of Radiation Induced Myelopathy. [2022]
Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial. [2023]
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