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New treatment option for Solid Tumor Spine Metastases
Official title Spine SABR - Dose-escalated Stereotactic Ablative Body Radiotherapy (SABR) for Solid Tumour Spine Metastases
ClinicalTrials.gov ID: NCT06078813
What this study is testing
- What it's testing
- This study will look at treatment for patients that have already been diagnosed with cancer, but develop a new tumor(s) in the spine. Patients who are not recommended for surgery are usually treated with 5-10 sessions of radiotherapy to manage symptoms.
- Phase 2: a mid-size study of how well it works
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
- Written informed consent obtained prior to any study-related procedures
- ≥ 18 years of age
- Life expectancy \> 6 months
- ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2
- Histological diagnosis of malignant primary disease (excluding haematologic, seminomatous or small cell subtype)
You likely can't join if
- Previous radiotherapy or surgery to the proposed SABR treatment site which is likely to interfere with treatment or assessment of outcomes (for...
- Patients with symptomatic spinal cord compression or cauda equina syndrome, resulting in bony compression or epidural compression of the spinal cord...
- Patients with syndromes or conditions associated with increased radiosensitivity
- Patients with radiosensitive histologies, e.g. myeloma or lymphoma
- Contraindication to MRI, e.g. MRI-incompatible personal pacemaker in situ
- Patients with pre-existing osteoporotic fractures of the spine
See the full eligibility criteria
- Written informed consent obtained prior to any study-related procedures
- ≥ 18 years of age
- Life expectancy \> 6 months
- ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2
- Histological diagnosis of malignant primary disease (excluding haematologic, seminomatous or small cell subtype)
- Diagnosis of oligometastatic disease (OMD) or oligoprogressive disease (OPD) defined as:
- OMD where there are 1 to 5 metastatic lesions, with a controlled primary tumor being optional, but where all metastatic sites must be safely treatable (can be synchronous or metachronous to primary tumor diagnosis) with...
- OPD with 1 to 5 lesions progressing on a background of widespread but stable metastatic disease OR
- Systemic therapy-induced OMD where there are 1 to 5 persistent lesions after systemic therapy, all safely treatable with SABR
- Single spinal level from C1 to L5 to be treated for the purpose of the study (co-existing lesion(s) on non-consecutive spinal level(s) may receive RT at Investigator discretion, if deemed unlikely to interfere with...
- Stable spine assessed by Spinal Instability Neoplastic Score (SINS) (SINS 0-6, or SINS 7-12 and not for surgical intervention).
- Bilsky Grade 0-1a (i.e. minimal (epidural impingement, without deformation of thecal sac) or no epidural disease) as confirmed by Radiation Oncologist
- Able to lie flat in the treatment position for radiotherapy for up to 60 minutes
- Females of childbearing potential must not be pregnant or lactating, and must be prepared to take adequate contraception methods during treatment. Males whose female partners are of childbearing potential must be...
- Previous radiotherapy or surgery to the proposed SABR treatment site which is likely to interfere with treatment or assessment of outcomes (for radiotherapy, this includes prior thoracic radiotherapy to the lung or...
- Patients with symptomatic spinal cord compression or cauda equina syndrome, resulting in bony compression or epidural compression of the spinal cord or cauda equine, respectively
- Patients with syndromes or conditions associated with increased radiosensitivity
- Patients with radiosensitive histologies, e.g. myeloma or lymphoma
- Contraindication to MRI, e.g. MRI-incompatible personal pacemaker in situ
- Patients with pre-existing osteoporotic fractures of the spine
- Prior treatment with any radionuclide within 30 days prior to registration
- Patients who have received chemotherapy within 1 week prior to administration of protocol RT or who are expected/planned to receive chemotherapy during RT or within 1 week after completing protocol RT
- Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes, or psychiatric illness/social situations that would limit compliance with study requirements
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study, or if it is felt by the research / medical team that the patient may not...
- Significant or progressive neurological deficit such that emergency surgery or radiation required
The study team makes the final eligibility decision.
Where it's taking place
- Cork, Ireland
- Dublin, Ireland
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 Cork, Ireland; Dublin, Ireland. 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.