RTOG 0236
For medically inoperable stage I NSCLC, does stereotactic body radiotherapy provide durable primary-tumour control?
Reported outcome visualization
Key results
At 3 years, primary-tumour control was 97.6%; 3-year overall survival was 55.8%. Long-term follow-up reported 5-year primary-tumour control 92.7%, local control 80.4%, regional recurrence 10.9%, and overall survival 40.0%.
Absolute Effect
Single-arm study: no randomized comparator, so comparative absolute benefit and NNT are not estimable.
NNT: Not quantifiable or not appropriate for this design/end point.
NNH: Not applicable to the single-arm study; grade 3 toxicity 27.3%, grade 4 3.6%, and grade 5 1.8% were reported.
Time-to-event interpretation: Hazard ratios and median survival are relative/time-to-event measures; they are not converted into NNT unless a fixed-time absolute event estimate is available.
Toxicity and treatment burden
Grade 3 toxicity occurred in 27.3%, grade 4 in 3.6%, and grade 5 treatment-related toxicity in 1.8% in the original report. Chest-wall, pulmonary and rib toxicity require attention; the cohort was small.
Follow-up, limitations and maturity
Follow-up: Median follow-up was 34.4 months for the original analysis; long-term report median follow-up approximately 7 years.
Small, single-arm phase II cohort; only peripheral lesions were eligible and the trial predates some modern staging and planning techniques. Do not compare its outcomes directly with surgical cohorts.
Clinical interpretation
SBRT achieved high primary-tumour control in medically inoperable peripheral stage I NSCLC, but this trial does not establish equivalence to surgery in operable patients.
Primary publication and sources
Timmerman R, et al. JAMA. 2010;303:1070–1076; long-term follow-up: JAMA Oncol. 2014.
Current-practice context · reviewed 15 October 2026
SBRT is an established definitive treatment for medically inoperable early-stage NSCLC and selected patients who decline surgery. It should not be presented as proven equivalent to lobectomy for otherwise operable patients: RTOG 0236 was a small, single-arm study of peripheral lesions. For operable patients, surgical fitness, nodal staging, tumour location and multidisciplinary assessment remain central.