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New treatment option for Metastatic Neoplasm to the Spine
Official title Spine Radiosurgery for Symptomatic Metastatic Neoplasms
ClinicalTrials.gov ID: NCT05617716
What this study is testing
- What it's testing
- The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging.
- Participant must have received no prior therapies for this disease. Prior therapy includes previous radiation therapy encompassing the anatomic site...
- Age \>18 years. This study requires informed consent by the participant; as children are not able to perform this without parental approval...
- Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.
- Participant must have a worst pain score \< 2 of 10 according to the Brief Pain Inventory
You likely can't join if
- Participant receiving any other investigational agents.
- Participant with prognosis less than 3 months will be excluded from this clinical trial because of their poor prognosis and decreased likelihood to...
- Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure...
- Pregnant or nursing Participant are excluded due to toxicity of radiation therapy.
- Participant is unable to receive MRI of the spine
- Participant has a Spinal Instability in Neoplasia score (SINS) ≥ 12
See the full eligibility criteria
- Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging.
- Participant must have received no prior therapies for this disease. Prior therapy includes previous radiation therapy encompassing the anatomic site to be treated with spine SBRT. This includes any previous radiation...
- Age \>18 years. This study requires informed consent by the participant; as children are not able to perform this without parental approval, Participant \< age 18 are excluded from this study.
- Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.
- Participant must have a worst pain score \< 2 of 10 according to the Brief Pain Inventory
- Participant must have no intention of changing pain medications on the first day of SBRT
- Participant must have a Spinal Instability score (SINS) ≤ 12
- Participant must be a spine SBRT candidate per Radiation Oncology
- Participant must have the ability to understand and the willingness to sign a written informed consent document
- Participant receiving any other investigational agents.
- Participant with prognosis less than 3 months will be excluded from this clinical trial because of their poor prognosis and decreased likelihood to meet the primary endpoint
- Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
- Pregnant or nursing Participant are excluded due to toxicity of radiation therapy.
- Participant is unable to receive MRI of the spine
- Participant has a Spinal Instability in Neoplasia score (SINS) ≥ 12
- Participant has received previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
- Participant has more than 3 consecutive vertebral bodies in the SBRT treatment volume
- Participant is not an SBRT candidate per radiation oncology discretion
- Participant has a known primary and has an estimated median survival≤ 3 months
- Participant has an unknown primary
- Participant has a Brief Pain Inventory score \> 2
- Participant has received previous radiation therapy involving the intended SBRT treatment field
- Participant has received previous spinal surgical procedure involving the SBRT target volume. Biopsy is not considered a previous spinal surgical procedure.
- Participant has neurological deficits from malignant cauda equina compression or epidural spinal cord compression
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.