{"entity":{"id":"stars-rosel","kind":"trial","name":"STARS and ROSEL pooled analysis","aka":["STARS","ROSEL","SABR versus lobectomy"],"tldr":"Two small trials that tried to ask whether precision radiotherapy could replace an operation for early lung cancer, closed early because almost nobody would agree to be randomised, and left the question open.","summary":"STARS and ROSEL both randomised patients with operable clinical stage I non-small-cell lung cancer to stereotactic ablative radiotherapy or lobectomy, and both closed early because patients and surgeons would not accept randomisation. Pooling them gave 58 patients, 31 assigned to radiotherapy and 27 to surgery.\n\nAt a median 40.2 months (radiotherapy) and 35.4 months (surgery), estimated three-year overall survival was 95 percent with radiotherapy against 79 percent with surgery (hazard ratio 0.14, 95 percent confidence interval 0.017 to 1.190, log-rank p=0.037), with six deaths in the surgical arm and one in the radiotherapy arm. Three-year recurrence-free survival was 86 against 80 percent (hazard ratio 0.69, p=0.54): the survival difference came from deaths not caused by the cancer. Grade 3 adverse events occurred in 3 of 31 radiotherapy patients and 12 of 27 surgical patients, with one surgical death.\n\nThe authors were explicit that 58 patients and three years cannot change practice, and the result is best read as a reason to run the larger trials (STABLE-MATES, VALOR and SABRTooth) rather than as evidence that radiotherapy is better. For patients who are medically inoperable, stereotactic radiotherapy is already the standard, which CHISEL established against conventional radiotherapy.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00840749","url":"https://clinicaltrials.gov/study/NCT00840749"},{"label":"ClinicalTrials.gov NCT00687986","url":"https://clinicaltrials.gov/study/NCT00687986"},{"label":"STARS and ROSEL pooled analysis (Lancet Oncology 2015)","url":"https://doi.org/10.1016/S1470-2045(15)70168-3"}],"tags":[],"related":[],"cancers":["resectable-nsclc"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["curative-intent"],"trials":["chisel","jcog0802","calgb-140503"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Operable clinical stage I non-small-cell lung cancer: stereotactic ablative radiotherapy versus lobectomy with mediastinal node dissection or sampling, pooled from two randomised trials that closed early","sponsor":"MD Anderson Cancer Center (STARS) and VU University Medical Center (ROSEL)","result":"Pooled three-year overall survival 95 percent with stereotactic radiotherapy against 79 percent with surgery (hazard ratio 0.14, p=0.037) in 58 patients; recurrence-free survival not significantly different.","yearReported":2015,"enrolled":58,"enrolledBasis":"randomised","enrolledNote":"58 patients were randomised across the two trials before both closed early for slow accrual; the registry figures for NCT00840749 and NCT00687986 are the planned targets.","outcomes":[],"replication":"Not replicated; the larger randomised comparisons are still running. CHISEL separately showed stereotactic radiotherapy beats conventional radiotherapy in inoperable stage I disease."},"route":"/trials/stars-rosel/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"resectable-nsclc","kind":"cancer","name":"Resectable stage I to III non-small-cell lung cancer","route":"/cancers/resectable-nsclc/"}],"technology":[{"id":"sbrt","kind":"technology","name":"SBRT / SABR (stereotactic radiotherapy)","route":"/technologies/sbrt/"}],"term":[{"id":"curative-intent","kind":"term","name":"Curative intent vs palliative intent","route":"/terms/curative-intent/"}],"trial":[{"id":"calgb-140503","kind":"trial","name":"CALGB 140503 (Alliance)","route":"/trials/calgb-140503/"},{"id":"chisel","kind":"trial","name":"CHISEL (TROG 09.02)","route":"/trials/chisel/"},{"id":"jcog0802","kind":"trial","name":"JCOG0802 / WJOG4607L","route":"/trials/jcog0802/"}]}}