NCT06078813

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Cancer Trials Ireland · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor Spine Metastases

Interventions

Type	Name	Description
RADIATION	Radiation: image guided dose escalated SABR using a simultaneous integrated boost (SIB)	Treatment will consist of image guided dose escalated SABR using a simultaneous integrated boost (SIB) delivered in two fractions adhering to organ at risk dose-volume histogram constraints. There will be three dose levels delivered to the Planning Target Volume\_1 (PTV\_1) in each treatment arm as follows: 28 Gy (14 Gy per fraction), 30 Gy (15 Gy per fraction) and 32 Gy (16 Gy per fraction). A lower dose of 20 Gy (10 Gy per fraction) will be delivered to the PTV\_2 which will be defined according to international consensus guidelines (Cox et al., 2012). The dose to PTV\_2 will remain the same through all dose levels. All doses are prescribed to the target volume.

Timeline

• Start date: 2023-11-21
• Primary completion: 2028-08-31
• Completion: 2034-04-01
• First posted: 2023-10-12
• Last updated: 2025-04-30

Locations

3 sites across 1 country: Ireland