Table 8. Phase I/II studies of neoadjuvant rectal cancer CRT using concurrent capecitabine plus irinotecan.

Author	Phase	Total no. of subjects	Pelvic staging method	Clinical stage	RT dose	Capecitabine dose	Irinotecan dose	Grade 3/4 toxicity	PCR rate	R0 resection rate
Hofheinz et al (2005)	I dose escalation	19	TRUS Pelvic CT	T3 n=18 T4 n=1	50.4 Gy 28 Fr 5.5 weeks	500 mg m−2 bd days 1–38a	50 mg/m2 weekly × 5	1/12 gr 3 fatigue	4 of 19 resected =21%	NS
						625 mg m−2 bd days 1–38	50 mg/m2 weekly × 5	3/7 gr 3 diarrhoea 1/7 gr 3 N+V 1/7 gr 3 anorexia 1/7 gr 3 leukopenia
Klautke et al (2006)	I/II	28	TRUS Pelvic CT	T2 n=2 T3 n=18 T4 n=8	55.8 Gy 31 Fr 6 weeks	500 mg m−2 bd days 1–43	40 mg/m2 weekly × 6	0/3	4 of 25 resected =15%	24/25 (96%)
						650 mg m−2 bd days 1–43	40 mg/m2 weekly × 6	0/3
						750 mg m−2 bd days 1–43a	40 mg/m2 weekly × 6	6/16 (38%) gr 3 diarrhoea
						825 mg m−2 bd days 1–43	40 mg/m2 weekly × 6	3/6 gr 3 diarrhoea 2/6 gr 4 diarrhoea 1/6 gr 3 HFS 1/6 gr 3 leukopenia
Willeke et al (2007)	II	36	TRUS Pelvic CT	T2 n=4 T3 n=26 T4 n=5	50.4 Gy 28 Fr 5.5 weeks	500 mg m−2 bd days 1–38	50 mg/m2 weekly × 5	4/36 (11%) gr 3 diarrhoea 2/36 gr 3 N+V 1/36 gr 3 fatigue 7/36 gr 3 leukopenia 2/36 gr 4 leukopenia	5 of 34 resected =15%	34/34 100%
Klautke et al (2007)	II	20	TRUS Pelvic CT	T3 n=18 T4 n=2	55.8 Gy 31 Fr 6 weeks	750 mg m−2 bd days 1–14, 22–35	50 mg/m2 weekly × 4 (days 1, 8, 22, 29	2/10 (10%) gr 3 diarrhoea	0	20/20 100%
	II	20		T2 n=1 T3 n=16 T4 n=3		750 mg m−2 bd days 1–14, 22–35	60 mg/m2 weekly × 4 (days 1, 8, 22, 29	3/20 (10%) gr 3 diarrhoea	7 of 20 resected =35%	19/20 (95%)

Abbreviations: Day 1=first day of RT; TRUS=trans rectal ultrasound; N+V=nausea and vomiting; NS=not stated; HFS=hand foot syndrome.

^aRecommended dose.