High-dose targeted radiation for spine tumors in cancer patients

Spine SABR - Dose-escalated Stereotactic Ablative Body Radiotherapy (SABR) for Solid Tumour Spine Metastases

This study is testing whether a higher dose of targeted radiation given in just two sessions can help cancer patients with spine tumors who can’t have surgery feel better and control their cancer.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Trials Ireland (network)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 3 sites (Cork and 2 other locations)
• Trial ID: NCT06078813 on ClinicalTrials.gov

What this trial studies

This study investigates the use of dose-escalated Stereotactic Ablative Body Radiotherapy (SABR) for patients with solid tumor spine metastases who are not candidates for surgery. The approach aims to deliver higher doses of radiation in just two sessions instead of the traditional 5-10 sessions, potentially improving pain relief and cancer control while monitoring for side effects. The study will determine the maximum safe dose of this modern treatment technique, which requires specialized equipment and expertise. It focuses on patients with a life expectancy of over six months and oligometastatic or oligoprogressive disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a life expectancy greater than six months and specific types of metastatic spinal tumors.

Not a fit: Patients with hematologic malignancies or those with extensive metastatic disease beyond the study's criteria may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide longer-lasting pain relief and improved survival for patients with spine metastases.

How similar studies have performed: Other studies have shown promising results with similar high-dose SABR approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent obtained prior to any study-related procedures
2. ≥ 18 years of age
3. Life expectancy \> 6 months
4. ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2
5. Histological diagnosis of malignant primary disease (excluding haematologic, seminomatous or small cell subtype)
6. Diagnosis of oligometastatic disease (OMD) or oligoprogressive disease (OPD) defined as:

   1. 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 curative intent OR
   2. OPD with 1 to 5 lesions progressing on a background of widespread but stable metastatic disease OR
   3. Systemic therapy-induced OMD where there are 1 to 5 persistent lesions after systemic therapy, all safely treatable with SABR
7. 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 study treatment and assessment of outcomes).
8. Stable spine assessed by Spinal Instability Neoplastic Score (SINS) (SINS 0-6, or SINS 7-12 and not for surgical intervention).
9. Bilsky Grade 0-1a (i.e. minimal (epidural impingement, without deformation of thecal sac) or no epidural disease) as confirmed by Radiation Oncologist
10. Able to lie flat in the treatment position for radiotherapy for up to 60 minutes
11. 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 prepared to take adequate contraception methods during treatment. Examples of effective contraception methods are a condom or a diaphragm with spermicidal jelly, or oral, injectable or implanted birth control

Exclusion Criteria:

1. 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 oesophagus which would result in overlap of fields if a T spine lesion will be treated)
2. 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
3. Patients with syndromes or conditions associated with increased radiosensitivity
4. Patients with radiosensitive histologies, e.g. myeloma or lymphoma
5. Contraindication to MRI, e.g. MRI-incompatible personal pacemaker in situ
6. Patients with pre-existing osteoporotic fractures of the spine
7. Prior treatment with any radionuclide within 30 days prior to registration
8. 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
9. 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
10. 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 be able to comply with the protocol and follow-up schedule due to psychological, familial, sociological or geographical conditions
11. Significant or progressive neurological deficit such that emergency surgery or radiation required

Where this trial is running

Cork and 2 other locations

• Bon Secours/UPMC — Cork, Ireland (RECRUITING)
• St Luke's Radiation Oncology Network (SLRON) at Beaumont Hospital — Dublin, Ireland (RECRUITING)
• Beacon Hospital — Dublin, Ireland (RECRUITING)

Study contacts

• Principal investigator: Clare Faul, MBBS — Cancer Trials Ireland/ St Luke's Radiation Oncology Network
• Study coordinator: Cancer Trials Ireland

Conditions: Solid Tumor Spine Metastases, Dose-Escalated Stereotactic Ablative Body Radiotherapy