TABLE 5

Completed randomised controlled trials comparing SBRT versus surgery

Dutch ROSEL trial (NCT00687986) [41]US STARS trial (NCT00840749) [41]US ACOSOG z4099 trial (NCT01336894) [42]
Surgical study armAnatomical resection with lymph node dissectionAnatomical resectionSLR ± brachytherapy
SBRT study arm60 Gy in three fractions or 60 Gy in five fractions60 Gy in three fractions or 60 Gy in four fractionsVariable dose in three fractions
EligibilityOperable patients, stage IA diseaseOperable patients, stage IA & IB disease ≤4 cm“High operable risk” patients, stage IA disease
Primary end-point5 year local control3 year OS5 year OS
Secondary end-pointsToxicity, OS, quality adjusted life yearsToxicity, progression-free, disease-specific survivalToxicity, DFS
Recruitment22 patients36 patients13 patients
  • SBRT: stereotactic body radiotherapy; OS: overall survival; SLR: sub-lobar resection; DFS: disease-free survival.