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Radiation

SBRT to the spine for Lung Cancer

Phase 2

Recruiting

Led By Kartik Mani, MD PhD

Research Sponsored by Stony Brook University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids

Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 months, 3 months, 6 months

Awards & highlights

Study Summary

This trial is testing a radiation therapy to treat cancer in the spine without the need for major surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests if stereotactic body radiation therapy (SBRT) can effectively treat aggressive spinal metastases in cancer patients without needing major surgery.See study design

What are the potential side effects?

Potential side effects of SBRT may include localized pain, temporary swelling, fatigue, skin reactions at the treatment site, and less commonly nerve damage which could affect sensation or movement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My muscle strength is mostly normal, at least 4 out of 5, with or without medication.

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I have a diagnosed solid tumor cancer that has spread, not originating from the brain or spinal cord.

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My cancer has spread to my spine, confirmed by scans.

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My spine issue affects up to 3 connected vertebrae.

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I can care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 months, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 months, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 months, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT

Secondary outcome measures

Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire

Changes on Neck Disability index

Changes on Oswestry Low Back Disability Questionnaire

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SBRT to the spineExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor

216 Previous Clinical Trials

39,945 Total Patients Enrolled

The University of Texas Health Science Center at San AntonioOTHER

453 Previous Clinical Trials

91,404 Total Patients Enrolled

Kartik Mani, MD PhDPrincipal InvestigatorStony Brook Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does stereotactic body radiation therapy pose a risk to the spine?

"Our internal assessment at Power has determined SBRT to the spine's safety rating is 2, as it is currently in its second phase of clinical trials. This affirms that there exists evidence that this treatment modality is safe but not yet efficacious."

Answered by AI

Are there still opportunities for patient enrollment in this research?

"According to the records on clinicaltrials.gov, this medical experiment is not presently looking for any more participants. It was initially posted in December 1st 2023 and subsequently updated at the same date, so it appears that no further recruitment is being conducted. Nevertheless, there are 997 other trials enrolling patients now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Definitive Radiation for High-Risk Spine Metastases

Kartik Mani 2023. "Definitive Radiation for High-Risk Spine Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06165419.

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