OPTIMISE Lung SABR

To assess the incidence of ≥ Grade 3 treatment-related Adverse Events (TxR)-AEs/toxicities using NCI CTCAE V5.

The incidence of treatment-related adverse events (TxR-AEs) of Grade ≥3 will be assessed separately for the three-fraction and five-fraction stereotactic ablative radiotherapy (SABR) regimens in patients with inoperable, peripherally located tumours. The incidence will be calculated as the proportion of evaluable patients experiencing at least one Grade ≥3 TxR-AE, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, from the start of radiotherapy through 2 years following treatment. For each treatment arm, the proportion and corresponding 95% confidence interval will be reported based on the total number of evaluable patients. Descriptive summaries will include patient disposition, reasons for exclusion from analysis, baseline and pre-treatment characteristics, and the frequency and severity of adverse events.

Acute toxicity profiles of Grade ≥2 treatment-related toxicities.

Acute toxicity rates of Grade ≥2 for each arm, using NCI CTCAE V5 at the end of Radiotherapy (RT), 4 weeks, 8 weeks and 3 months post-RT.

Late toxicity profiles of Grade ≥2 treatment-related toxicities

Late toxicity rates of Grade ≥2 for each arm, using NCI CTCAE V5 at 6, 9, 12, 18, 24, 36, 48 and 60 months post-RT.

Treatment-related 2-year cumulative rate of NCI CTCAE V5 Grade ≥2 Chest Wall toxicity and Rib fracture for the three fraction and five fraction regimens.

The incidence of NCI CTCAE V5 Grade ≥2 treatment-related Chest wall, and Rib fracture toxicities, for each arm, independently. These calculations include 95% confidence Intervals. Chest wall toxicity consists of a combination of symptoms; a full list of considered toxicities will be documented in the Statistical Analysis Plan.

Time to onset of acute and late Grade ≥2 and Grade ≥3 study treatment related toxicities.

For each arm, time-to-event analyses will be conducted separately for time to onset of acute and late NCI CTCAE V5 grade ≥2 and grade ≥3 toxicities which are related to trial treatments. Evaluable Patients who have been lost to follow-up, withdrawn, or have not experienced the event by the time of analysis will be censored at their last available toxicity assessment.