Table 2. Randomised control trials of IORT versus WBI in early-breast cancer.

Trial name	Sample size	Age	Inclusion criteria	IORT type	IORT dose	Trial design	Local recurrence (5yr)	Overall survival/mortality (5yr)
ELIOT [28]	1305 median follow-up: 5.8 years	> 48 years	any invasive cancer < 2.5 cm	IOERT	ELIOT:21 Gy/1# to tumour bed with 6–9 MeV electrons WBI:50 Gy/25# + 10 Gy/5# boost	Equivalence trial: Statistical margin was local recurrence of 7.5% in the IORT group	ELIOT:4.4% (95% C.I: 2.7–6.1) WBI: 0.4% p < 0.0001	ELIOT:96.8% WBI: 96.9%
TARGIT-A [27]	3451 Median follow-up: 2.5 years	> 45years	T1-2, N0, 1 IDC < 3.5 cm (If EIC or ILC on final histology, add whole breast RT)	X-ray IORT (50 kv X-ray)	TARGIT: 20 Gy to tumour bed 5–7 Gy at 1 cm depth WBI: 40–56 Gy with or without boost 10–16 Gy	Non-inferiority trial: Statistical margin was 2.5% difference in local recurrence at 5 years	TARGIT:3.3% (95% CI: 2.1–5.1) WBI:1.3% (95% CI: 0.7–2.5) p = 0.042	TARGIT:3.9% WBI: 5.3 p = 0.009

EIC: extensive intraductal component, ILC: invasive lobular cancer, WBI: whole breast RT.