Role of radiation therapy in neoadjuvant era in patients with locally advanced rectal cancer

Table 3 Randomized trials of preoperative radiation therapy combined with chemotherapy in locally advanced rectal carcinoma

Author, year published	n	Treatment arms	Local recurrence	Overall survival
Gérard et al[18], 2006 (FFCD-9203)	742	Arm 1 (367 patients): preoperative RT (45 Gy/25 fractions/5 wk) followed by TME between 3-10 wk after RT	At 5 yr follow-up	5-yr survival rate
			16.5% Arm 1	67.9% Arm 1
		Arm 2 (375 patients): preoperative RT (45 Gy/25 fractions/5 wk) + CH (2 cycles: first on days 1-5 of RT and the second on days 29-33 of RT) followed by TME between 3-10 wk after CHRT	8.1% Arm 2	67.4% Arm 2
			(P = 0.004)	(P = 0.684)
Bosset et al[19], 2006 (the EORTC Radiotherapy Group Trial 22921)	1011	Arm 1 (252 patients): preoperative RT (45 Gy/25 fractions/5 wk) followed by TME between 3-10 wk after RT	5 yr of follow-up	5-yr survival rate
			17.1% Arm 1	63.2% Arm 1
		Arm 2 (253 patients): Same RT as in Arm 1 + 2 cycles of CH (days 1-5 and 29-33 of RT) + TME between 3-10 wk after CHRT	8.7% Arm 2	63.2% Arm 2
			9.6% Arm 3	67.2% Arm 3
		Arm 3 (253 patients): Same RT as in Arm 1 + TME between 3-10 wk after RT + 4 cycles of CH postoperative	7.6% Arm 4	67.2% Arm 4
			(P = 0.002)	(P = 0.12)
		Arm 4 (253 patients) Same RT as in Arm 1 + 2 cycles of CH (days 1-5 and 29-33 of RT) + TME between 3-10 wk after CHRT + 2 cycles of CH postoperative
Bujko et al[20], 2005	312	Arm 1 (155 patients): preoperative RT (5 Gy × 5 d) followed by TME at 7 d after RT	4 yr of follow-up	4-yr survival rate
			59% Arm 1	67.2% Arm 1
		Arm 2 (157 patients): preoperative RT (45 Gy/25 fractions/5 wk) + 2 cycles of chemotherapy on weeks 1 and 5 of RT) followed by TME between 4-6 wk later. The cycle consisted of leucovorin 20 mg/m2 per day and, 10-20 min later, 5-fluorouracil 325 mg/m2 per day, both administered as rapid infusion on 5 consecutive days	14.2% Arm 2	66.2% S alone
			(P = 0.170)	(P = 0.960)

TME: Total mesorectal excision; RT: Radiation therapy; CHRT: Chemo-radiation therapy; CH: Chemotherapy (Leukovorin 20 mg/m² per day was delivered intravenously immediately before administration of Fluorouracil and Fluorouracil 350 mg/m² per day was delivered during 20 min in 100 mL of saline infusion, 1 h before RT).