130 Participants Needed

Spine Stereotactic Radiosurgery for Spinal Cancer

ST
EB
Overseen ByEhsan Balagamwala, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Case Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue. One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.

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 Spine Stereotactic Radiosurgery for Spinal Cancer?

Research shows that stereotactic body radiotherapy (SBRT) is highly effective for treating spinal metastases, with improved pain relief and local control compared to traditional methods. A specific regimen of 24 Gy in 2 fractions has strong evidence for balancing effectiveness and minimizing side effects.12345

Is Spine Stereotactic Radiosurgery (SRS) safe for humans?

Spine Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) are generally considered safe, but they do carry some risks. Studies have shown that while these treatments can effectively target spinal tumors, they may increase the risk of vertebral body fractures (breaks in the bones of the spine).34567

How is Spine Stereotactic Radiosurgery (SRS) different from other treatments for spinal cancer?

Spine Stereotactic Radiosurgery (SRS) is unique because it delivers high-dose radiation precisely to spinal tumors in one or two sessions, minimizing damage to surrounding healthy tissue. This advanced technique is particularly beneficial for treating tumors near the spinal cord, where conventional radiation might not be feasible due to the risk of damaging the spinal cord.12589

Research Team

Samuel Chao, MD | Cleveland Clinic

Samuel T. Chao, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with cancer that has spread to their spine, affecting up to three separate sites without causing spinal cord compression. Participants must be in good physical condition (KPS โ‰ฅ 70), able to undergo MRI scans, and not pregnant. Those who've had prior radiation at the index site may join, but not if they've had specific spine treatments or have certain types of cancer like lymphoma.

Inclusion Criteria

Negative pregnancy test within four weeks of registration for women of childbearing potential.
My overall health status fits within a specific range and my cancer is either controlled or not, depending on other health factors.
History and physical within four weeks of registration.
See 11 more

Exclusion Criteria

You have an ongoing connective tissue disease that is currently active.
My cancer has spread to more than 5 levels of my spine.
I have a spinal cord compression that needs urgent care.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spine stereotactic radiosurgery (sSRS) in either one or two sessions depending on the assigned group

1-2 weeks
1-2 visits (in-person)

Follow-up

Participants are monitored for vertebral compression fractures, quality of life, local control, pain control, and toxicity

12 months
Follow-up MRIs at 1 month, 3 months, 6 months, and 12 months

Treatment Details

Interventions

  • Spine SRS in 1 fraction
  • Spine SRS in 2 fraction
Trial Overview The study compares single-session versus two-session Spine Stereotactic Radiosurgery (sSRS) for treating vertebral metastases. It aims to determine which method better prevents vertebral compression fractures after delivering high-dose x-ray treatments focused on the affected areas of the spine.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1 - Single fractionExperimental Treatment6 Interventions
sSRS 18 Gy in 1 fraction
Group II: Arm 2 - Two fractionActive Control6 Interventions
sSRS 24 Gy in 2 fractions

Spine SRS in 1 fraction is already approved in United States, European Union, Canada, Japan for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Spine Stereotactic Radiosurgery for:
  • Vertebral metastases
  • Spinal tumors
  • Pain relief
  • Neurological symptoms
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Spine Radiosurgery for:
  • Vertebral metastases
  • Spinal tumors
  • Pain relief
  • Neurological symptoms
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Stereotactic Body Radiation Therapy (SBRT) for:
  • Vertebral metastases
  • Spinal tumors
  • Pain relief
  • Neurological symptoms
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as Spine Stereotactic Radiosurgery for:
  • Vertebral metastases
  • Spinal tumors
  • Pain relief
  • Neurological symptoms

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Findings from Research

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.
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 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.
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.
Stereotactic body radiotherapy as a primary treatment for spinal metastasis: a single institution experience.Yeung, WME.[2021]

References

Surgical resection of epidural disease improves local control following postoperative spine stereotactic body radiotherapy. [2022]
Stereotactic radiotherapy: an emerging treatment for spinal metastases. [2019]
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 body radiation for the spine: a review. [2013]
Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy. [2021]
Vertebral body fracture rates after stereotactic body radiation therapy compared with external-beam radiation therapy for metastatic spine tumors. [2023]
The role of stereotactic body radiotherapy and stereotactic radiosurgery in the re-irradiation of metastatic spinal tumors. [2014]
Spine radiosurgery for spinal metastases: indications, technique and outcome. [2014]
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