About this trial
This study is a phase II multi-centre, randomised study independently evaluating five fraction image-guided (IG)-SABR and three fraction IG-SABR for patients with a peripherally located T1-T2 and selected T3 and T4 lung tumours or a peripherally located single pulmonary oligometastatic lesion.
It has been demonstrated in lung tumours that SABR is more effective than conventional External Beam Radiation Therapy (EBRT) due to delivery of higher Biologically Equivalent Dose (BED). Chest Wall Toxicity is the most commonly reported toxicity for peripheral tumours. In order to reduce the risk of this toxicity a treatment regimen of five fractions is widely employed for tumours close to or overlapping chest wall (CW). A retrospective planning study carried out in SLRON has shown it is possible to optimise SABR plans to achieve acceptable risk of chest wall toxicity while maintaining the BED to the tumour volume and condensing the fractionation schedule to three fractions.
This study will identify patients with peripherally located tumours, defined as tumours not fulfilling the UK 2022 SABR Consortium Consensus optimal 3 fraction constraints for CW (0.1 cc < 36.9 Gy) or (30 cc < 30 Gy), with standard Planning Target Volume (PTV) coverage due to the proximity of their tumour to the CW, but which are predicted to meet the CTRIAL-IE 24-15 OPTIMISE Lung SABR Study Dose Volume Constraints (DVCs) with dose escalation optimised to the Gross Tumour Volume (GTV).
The purpose of this study is to:
– To determine the safety of two SABR fractionations: five fraction image-guided SABR, and optimised three fraction image guided SABR
Patients who are eligible to participate on this study will be assigned by chance (one chance in two) to one of two treatment groups via a process called randomisation. Patients will be asked to visit the study doctor for safety follow-up review for up to five years. About 208 people will be in the study in total.
Patient Profile
A peripherally located T1-T2 (and selected T3 and T4) Non Small Cell Lung Cancer tumour, or a peripherally located single pulmonary oligometastatic lesion. (lung cancer)
Where’s this trial being run?
St Luke’s Radiation Oncology Network @ St James’s Hospital and St Luke’s Radiation Oncology Network @ St Luke’s Hospital
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | OPTIMISE Lung SABR |
|---|---|
| Number: | 24-15 |
| Full Title: | OPTIMISE Lung SABR: OPTIMISation of pEripheral Lung Stereotactic Ablative Body Radiotherapy (SABR), a prospective independent evaluation of 3 fraction and 5 fraction SABR regimens. |
| Principal Investigator: | Prof. Pierre Thirion (SLRON), and Dr. Lorna Keenan (SLRON). |
|---|---|
| Type: | In-House |
| Sponsor: | Cancer Trials Ireland |
| Recruitment Started: |
Global: Oct 2026 Ireland: Oct 2026 |
| Global Recruitment Target: | 208 |
|---|---|
| Ireland Recruitment Target: |