Spine SABR

About this trial

Spine SABR is a Phase I/II, multi-centre, non-randomised trial. 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 study has been designed to determine the maximum tolerated dose of stereotactic radiotherapy, to the spine, delivered in two fractions with a simultaneous integrated boost technique, for patients with oligometastatic or oligoprogressive spine disease. There will be two parallel treatment arms (high versus low baseline risk of post-SABR VCF), and three dose levels of sequential escalation within each arm.

These results will help create national and international guidelines to benefit all cancer patients. 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

Patient Profile

The target population for this study are patients with oligometastatic disease (OMD) or oligoprogressive disease (OPD) solid tumour spine metastases.

Where’s this trial being run?

Beacon Hospital and St Luke’s Radiation Oncology Network @ Beaumont Hospital

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	Spine SABR
Number:	20-03
Full Title:	Dose-escalated Stereotactic Ablative Body Radiotherapy (SABR) for Solid Tumour Spine Metastases

Principal Investigator:	Prof Clare Faul (Chief Investigator)
Type:	In-House
Sponsor:	Cancer Trials Ireland
Recruitment Started:	Global: Ireland: November 2023

Global Recruitment Target:
Ireland Recruitment Target:	126