Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06078813

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

Led by Cancer Trials Ireland · Updated on 2025-04-30

126

Participants Needed

3

Research Sites

540 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent obtained prior to any study-related procedures
  • 18 years of age or older
  • Life expectancy greater than 6 months
  • ECOG performance status of 0 to 2
  • Histological diagnosis of malignant primary disease excluding haematologic, seminomatous, or small cell subtype
  • Diagnosis of oligometastatic or oligoprogressive disease with 1 to 5 metastatic lesions safely treatable with SABR
  • Single spinal level from C1 to L5 to be treated
  • Stable spine assessed by Spinal Instability Neoplastic Score (SINS) of 0-6, or 7-12 and not for surgical intervention
  • Bilsky Grade 0-1a (minimal or no epidural disease) confirmed by Radiation Oncologist
  • Able to lie flat in the treatment position for up to 60 minutes
  • Females of childbearing potential must not be pregnant or lactating and agree to use adequate contraception during treatment
  • Males with female partners of childbearing potential must agree to use adequate contraception during treatment
Not Eligible

You will not qualify if you...

  • Previous radiotherapy or surgery to the proposed SABR treatment site likely to interfere with treatment or assessment
  • Symptomatic spinal cord compression or cauda equina syndrome
  • Syndromes or conditions causing increased radiosensitivity
  • Radiosensitive histologies such as myeloma or lymphoma
  • Contraindication to MRI such as incompatible pacemaker
  • Pre-existing osteoporotic fractures of the spine
  • Prior radionuclide treatment within 30 days before registration
  • Chemotherapy within 1 week before radiotherapy or planned during or within 1 week after radiotherapy
  • Uncontrolled illnesses or psychiatric/social conditions limiting study compliance
  • Significant clinical disorders or laboratory findings making participation undesirable
  • Significant or progressive neurological deficits requiring emergency surgery or radiation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Bon Secours/UPMC

Cork, Ireland

Actively Recruiting

2

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

Dublin, Ireland, D09V2N0

Actively Recruiting

3

Beacon Hospital

Dublin, Ireland, D18 AK68

Actively Recruiting

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Research Team

C

Cancer Trials Ireland

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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