Table 3.

Randomized trials of surgery and postoperative radiotherapy (RT) versus surgery alone.

Study, year [Reference]	Participants	Number of patients	Interventions	Median Survival (Months)	Survival Rate (%)					Adverse Effects (Number of Patients)
					1 yr	2 yr	3 yr	4 yr	5 yr
Fok et al. 1993 [27]	130 patients July 1986-Dec 1989 Hong Kong, single centre squamous cell adenocarcinoma excluded leaks, respiratory failure, poor performance, metastases	65	esophagectomy + 49–52.5 Gy postop RT	8.7	34	18	16	16	-	gastritis, 6; ulcer, 17; tracheo-esophageal fistulae, 1; strictures, 6
		versus	versus	versus	versus					versus
		65	esophagectomy (Lewis-Tanner or transhiatal or sternal split)	15.2	65	25	21	16	-	gastritis, 3; ulcer, 1; tracheo-esophageal fistulae, 0; strictures, 6
					Shorter survival with RT (p = 0.02). Better local control with RT (p = 0.06) but with more complications.
Teniere et al. 1991 [28]	221 patients Dec 1979-Dec 1985 France, multi centre squamous cell distal 2/3 esophagus	102	esophagectomy + 45–55 Gy postop RT	18	68	50	27	24	21	minor, 18; major, 4; death, 1
		versus	versus	versus	versus					versus
		119	esophagectomy (transhiatal or right thoracotomy with stomach or colon interposition)	18	73	51	29	22	19	none reported
					No difference in survival (p-value not reported). Local or regional recurrence was lower with RT (70% versus 85%, p-value not reported).
Fok* 1994 [5]	79 patients 1968–1981 Hong Kong, single centre Squamous cell middle 1/3 esophagus	42	esophagectomy (one or two stage) + 45–53 Gy postop RT	11	48	17	17	12	10	respiratory 25; postoperative deaths 3; leaks 11
		versus	versus	versus	versus					versus
		39	esophagectomy (right thoracotomy, left neck, and abdomen)	22	58	36	24	16	16	respiratory 15; postoperative deaths 3; leaks 7
					No difference in survival.
Zieren et al. 1995 [29]	68 patients (did not accrue entire sample size 68/160) June 1988-Dec 1991 Germany, single centre squamous cell excluded cervical location, metastases, other cancers, previous treatment	33	esophagectomy + 55.8 Gy postop RT	14	57	29	22	-	-	tracheo-esophageal fistulae, 1; skin, 18; strictures, 2
		versus	versus	versus	versus					versus
		35	esophagectomy (transhiatal or right thoracotomy with stomach interposition)	13	53	31	20	-	-	strictures, 1
					No difference in survival (p-value not reported).
Xiao et al. 2003 [47]	495 patients	220	Midplane dose of 50–60 Gy in 25–30 fractions over 5–6 weeks	NR	-	-	-	-	41	NR
		versus	versus	versus	versus
		275	Surgery alone	NR	-	-	-	-	32
					p = 0.4474

Note: NR, not reported.

*Patients randomized to four groups; data shown are for surgery + radiotherapy versus surgery alone.