Table 4.

Randomized trials of preoperative chemo-radiotherapy vs postoperative chemo-radiotherapy in locally advanced rectal carcinoma

Author, year published	n	Treatment arms	Disease free survival-local relapse	Overall survival
Roh et al[22], 2009 (NSABP R-03)	267	Arm 1 (130 patients): preoperative CHRT: Chemo cycle 1: FU 500 mg/m2 once per week for 6 wk + LV 500 mg/m2 once per week for 6 wk followed by RT: 45 Gy in 25 fractions with a 5.4 Gy boost within the original margins of treatment + 2 cycles of FU 325 mg/m2 for 5 d LV 20 mg/m2 for 5 d (1st and 5th week of RT) followed by chemo cycles 4-7 as cycle 1	At 5 yr follow-up	5-yr survival rate
			64.7% DSF in Arm 1	74.5% Arm 1
			53.4% DSF in Arm 2	65.6% Arm 2
			(P = 0.011)	(P = 0.065)
		Arm 2 (137patients): postoperative CHRT: same as in Arm 1
Sauer et al[6], 2004 (German study)	823	Arm 1 (421 patients): preoperative CHRT: 50, 4 Gy/28 fractions/5 fractions weekly + FU 1000 mg/m2 120 h continuous infusion in first and fifth week of RT followed by 4 cycles of FU 500 mg/m2 per day/five times weekly every 4 wk followed by TME 6 wk after CHRT	5 yr of follow-up	5-yr survival rate
			6.0% LR in Arm 1	76.0% Arm 1
			13% LR in Arm 2	74.0% Arm 2
			(P = 0.006)	(P = 0.80)
		Arm 2 (402 patients): postoperative CHRT: same as in Arm 1 except a 5.4 Gy boost in RT
Sauer et al[23], 2012 (CAO/ARO/AIO-94 trial: results after 10 yr follow-up)	823	Arm 1 same as in above trial	10-yr of follow-up	10-yr survival rate
		Arm 2 same as in above trial	7.1% LR in Arm 1	59.6% in Arm 1
			10.1% in Arm 2	59.9% in Arm 2
			(P = 0.48)	(P = 0.85)

RT: Radiation therapy; CHRT: Chemo-radiation therapy; FU: Fluorouracil; LV: Leukovorin; DFS: Disease free survival; LR: Local relapse.