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

Last updated: April 29, 2025
Sponsor: Cancer Trials Ireland
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasm Metastasis

Treatment

Radiation: image guided dose escalated SABR using a simultaneous integrated boost (SIB)

Clinical Study ID

NCT06078813
CTRIAL-IE 20-03
  • Ages > 18
  • All Genders

Study Summary

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. For patients with a longer life expectancy (>6 months), it is better to give a higher dose of treatment to potentially improve the duration of pain relief, cancer control and potentially survival. Higher doses of radiotherapy, however, may also cause worse toxicity and side effects. This study will look at delivering higher doses of radiation in 2 sessions rather than 5-10, using a more modern, targeted technique called image-guided Stereotactic Ablative Body Radiotherapy (SABR). This method requires special equipment and expertise compared to the traditional radiotherapy and this has limited availability in Ireland. This study aims to find out the highest dose that is safe to be given to patients and carefully examine the side effects. These results will help create national and international guidelines to benefit all cancer patients. Patients will be monitored closely during treatment and for 2 years afterwards. Patients have been involved in developing the treatment protocol and the patient information leaflet. Patients will also be asked to fill in quality of life (QOL) questionnaires at certain timepoints during the study. It is anticipated that this study will support the delivery of high quality SABR to all cancer patients in Ireland, resulting in potentially better quality of life, symptom and tumor control.

Eligibility Criteria

Inclusion

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) definedas:

  7. OMD where there are 1 to 5 metastatic lesions, with a controlled primary tumorbeing optional, but where all metastatic sites must be safely treatable (can besynchronous or metachronous to primary tumor diagnosis) with curative intent OR

  8. OPD with 1 to 5 lesions progressing on a background of widespread but stablemetastatic disease OR

  9. Systemic therapy-induced OMD where there are 1 to 5 persistent lesions aftersystemic therapy, all safely treatable with SABR

  10. 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 atInvestigator discretion, if deemed unlikely to interfere with study treatment andassessment of outcomes).

  11. Stable spine assessed by Spinal Instability Neoplastic Score (SINS) (SINS 0-6, orSINS 7-12 and not for surgical intervention).

  12. Bilsky Grade 0-1a (i.e. minimal (epidural impingement, without deformation of thecalsac) or no epidural disease) as confirmed by Radiation Oncologist

  13. Able to lie flat in the treatment position for radiotherapy for up to 60 minutes

  14. Females of childbearing potential must not be pregnant or lactating, and must beprepared to take adequate contraception methods during treatment. Males whose femalepartners are of childbearing potential must be prepared to take adequatecontraception methods during treatment. Examples of effective contraception methodsare a condom or a diaphragm with spermicidal jelly, or oral, injectable or implantedbirth control

Exclusion

Exclusion Criteria:

  1. Previous radiotherapy or surgery to the proposed SABR treatment site which is likelyto interfere with treatment or assessment of outcomes (for radiotherapy, thisincludes prior thoracic radiotherapy to the lung or oesophagus which would result inoverlap 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 caudaequine, 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 ofprotocol 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 orassessment of outcomes, or psychiatric illness/social situations that would limitcompliance with study requirements

  10. Evidence of any other significant clinical disorder or laboratory finding that makesit undesirable for the patient to participate in the study, or if it is felt by theresearch / medical team that the patient may not be able to comply with the protocoland follow-up schedule due to psychological, familial, sociological or geographicalconditions

  11. Significant or progressive neurological deficit such that emergency surgery orradiation required

Study Design

Total Participants: 126
Treatment Group(s): 1
Primary Treatment: Radiation: image guided dose escalated SABR using a simultaneous integrated boost (SIB)
Phase: 1/2
Study Start date:
November 21, 2023
Estimated Completion Date:
April 01, 2034

Connect with a study center

  • Bon Secours/UPMC

    Cork,
    Ireland

    Active - Recruiting

  • Beacon Hospital

    Dublin, D18 AK68
    Ireland

    Active - Recruiting

  • St Luke's Radiation Oncology Network (SLRON) at Beaumont Hospital

    Dublin, D09V2N0
    Ireland

    Active - Recruiting

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