BACKGROUND: This study investigated the local effect and acute toxicity of 
irinotecan and capecitabine with concurrent intensity-modulated radiation 
therapy (IMRT) for the treatment of recurrent rectal cancer without prior pelvic 
irradiation.
METHODS: Seventy-one patients diagnosed with recurrent rectal cancer who did not 
previously receive pelvic irradiation were treated in our hospital from October 
2009 to July 2012. Radiotherapy was delivered to the pelvis, and IMRT of 45 Gy 
(1.8 Gy per fraction), followed by a boost of 10 Gy to 16 Gy (2 Gy per 
fraction), was delivered to the recurrent sites. The concurrent chemotherapy 
regimen was 50 mg/m(2) irinotecan weekly and 625 mg/m(2) capecitabine twice 
daily (Mon-Fri). Radical surgery was recommended for medically fit patients 
without extra-pelvic metastases. The patients were followed up every 3 months. 
Tumor response was evaluated using CT/MRIs according to the RECIST criteria or 
postoperative pathological findings. NCI-CTC 3.0 was used to score the 
toxicities.
RESULTS: Forty-eight patients (67.6%) had confirmed recurrent rectal cancer 
without extra pelvic metastases, and 23 patients (32.4%) had extra pelvic 
metastases. Fourteen patients (19.7%) underwent radical resections (R0) 
post-chemoradiation. A pathologic complete response was observed in 7 of 14 
patients. A clinical complete response was observed in 4 patients (5.6%), and a 
partial response was observed in 22 patients (31.0%). Only 5 patients (7.0%) 
showed progressive disease during or shortly after treatment. Of 53 symptomatic 
patients, clinical complete and partial symptom relief with chemoradiation was 
achieved in 56.6% and 32.1% of patients, respectively. Only 2 patients (2.8%) 
experienced grade 4 leukopenia. The most common grade 3 toxicity was diarrhea 
(16 [22.5%] patients). The median follow-up was 31 months. The cumulative local 
progression-free survival rate was 74.2% and 33.9% at 1 and 3 years after 
chemoradiation, respectively. The cumulative total survival rate was 80.1% and 
36.5% at 1 and 3 years after chemoradiation, respectively.
CONCLUSIONS: This study revealed that concurrent irinotecan and capecitabine 
with IMRT significantly relieves local symptoms and exhibits promising efficacy 
with manageable toxicities in recurrent rectal cancer without prior pelvic 
irradiation. Improving the rate of R0 resections will be investigated in a 
future study.