26 Participants Needed

Radiation for Spine Cancer

LJ
HM
Overseen ByHermina Munoz, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Stony Brook University
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
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a precise form of radiation, known as stereotactic body radiation therapy (SBRT), can treat spine cancer without major surgery. It targets individuals whose cancer has aggressively spread to the spine but who can still move around and have only minor muscle weakness. Participants must not have had any prior spine surgery or radiation for their condition. Those with certain types of cancer, such as small cell lung cancer, or an unstable spine are not eligible. The trial aims to find a less invasive treatment option that could improve quality of life. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that stereotactic body radiation therapy is likely to be safe for humans?

Research has shown that stereotactic body radiation therapy (SBRT) for spine cancer is generally safe and well-tolerated. Studies indicate that it has a good safety record, allowing most patients to undergo treatment without major issues.

Many patients experience significant pain relief, and the treatment effectively controls the disease. Some reports mention that up to 35% of patients experienced complete relief from spinal pain three months after treatment.

While more high-quality data is needed, current evidence suggests that SBRT is a reliable option for those with cancer that has spread to the spine.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about SBRT (Stereotactic Body Radiation Therapy) for spine cancer because it offers a more precise and focused radiation treatment compared to traditional methods. Unlike standard radiation therapies, which can affect surrounding healthy tissues, SBRT delivers high doses of radiation directly to the tumor with pinpoint accuracy, minimizing damage to the spinal cord and other sensitive areas. This precision not only has the potential to improve outcomes by effectively targeting the cancer cells, but it also reduces the risk of side effects and shortens the overall treatment time, offering a more convenient and tolerable option for patients.

What evidence suggests that SBRT is effective for spine cancer?

Research has shown that stereotactic body radiation therapy (SBRT), which participants in this trial will receive, works well for patients with metastatic spine cancer. Studies indicate that SBRT can stop cancer growth or shrink tumors in 80% to 96% of cases within one year. Additionally, SBRT has been found to reduce spinal pain for many patients. In one study, 35% of patients reported no spinal pain three months after receiving SBRT. Overall, SBRT offers a promising non-surgical treatment option for spine cancer.12346

Who Is on the Research Team?

Dr. Kartik M Mani, MD, PhD - Stony ...

Kartik M. Mani

Principal Investigator

Stony Brook Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with solid tumor cancers, excluding brain origin, that have spread to the spine. Participants must have a maximum of 3 affected spinal segments and maintain basic neurological function or minor deficits. They should be evaluated by specialists and have an ECOG Performance Status score between 0-3.

Inclusion Criteria

My muscle strength is mostly normal, at least 4 out of 5, with or without medication.
I have been evaluated by a specialist in cancer radiation and spine surgery.
My spine issue affects up to 3 connected vertebrae.
See 3 more

Exclusion Criteria

I have had surgery or radiation for cancer in my spine.
An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12
My cancer type is known to respond well to radiation therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic body radiation therapy (SBRT) to the spine

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Assessments at 1, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • SBRT
Trial Overview The study tests if stereotactic body radiation therapy (SBRT) can effectively treat aggressive spinal metastases in cancer patients without needing major surgery.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: SBRT to the spineExperimental Treatment1 Intervention

SBRT is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as SBRT for:
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Approved in European Union as SBRT for:
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Approved in Canada as SBRT for:
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Approved in Japan as SBRT for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials
225
Recruited
41,700+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials
486
Recruited
92,500+

Published Research Related to This Trial

In a study of 60 patients treated with spine SBRT, the 2-year local control rate was 70.6%, indicating that this treatment is effective for managing spine metastasis without significant toxicity.
Delaying SBRT for at least 6 months after the diagnosis of spinal lesions improved local control rates to 88%, suggesting that timing of treatment may enhance outcomes.
Long-term outcomes of spinal SBRT. Is it important to select the treatment time?Pérez-Montero, H., Godino, O., Lozano, A., et al.[2022]
Stereotactic ablative radiotherapy (SABR) demonstrated a high local control rate of 91.2% for skeletal metastases in a study of 22 patients, with a median follow-up of 15.6 months, indicating its effectiveness in managing oligometastatic and oligoprogressive diseases.
The treatment resulted in significant pain control for two-thirds of symptomatic patients, with limited toxicities reported, including only two vertebral fractures and one case of grade 3 esophagitis, suggesting that SABR is a safe option for patients with skeletal metastases.
Utilization of stereotactic ablative radiotherapy in oligometastatic & oligoprogressive skeletal metastases: Results and pattern of failure.Kam, TY., Chan, OSH., Hung, AWM., et al.[2019]
In a study of 85 patients with spine metastases treated with stereotactic ablative radiation therapy (SABR), the treatment demonstrated a 74.1% overall survival rate at two years and a 72.3% local control rate, indicating its efficacy in managing spinal metastases.
SABR was associated with significant pain relief, as 83.3% of patients with pre-treatment pain experienced a complete response, and the treatment showed a favorable safety profile with no severe toxicities reported.
Stereotactic ablative radiation therapy for spinal metastases: experience at a single Brazilian institution.Marta, GN., de Arruda, FF., Miranda, FA., et al.[2023]

Citations

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 ...
Efficacy and safety of SBRT for spine metastasesThe currently available data including 5 randomized trials of SBRT for spine metastases confirm that spine SBRT is an effective therapy for ...
Stereotactic Body Radiation Therapy for Spinal MetastasesIn conclusion, the available evidence for salvage re-irradiation with spine SBRT indicates that it is effective (local failure ∼ 15-25% at 12 months); generally ...
Treatment outcomes of stereotactic body radiation therapy for ...SBRT for spinal sarcoma is effective in achieving local control, particularly when treating a single vertebral level with a limited extent of disease ...
Radiation to Treat Painful Spinal Metastases - NCIThree months after treatment, 35% of people in the SBRT group reported that their spinal pain was gone, compared with 14% of the people who ...
Stereotactic body radiation therapy for spinal metastasesIn this review, we highlight the indications and controversies of SBRT along with new surgical techniques for the treatment of spinal metastases.
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