659 Background: Squamous cell carcinoma (SCC) of the anal canal is an uncommon malignancy accounting for 1-5% of intestinal tumors; however, its incidence has been increasing. The standard treatment of anal canal SCC stage II-III consists of infusional 5-fluorouracil associated with mitomycin and radiotherapy. This scheme was proposed by Nigro in 1974, and since then no other effective treatment was developed. Methods: Patients with SCC of anal cancer T2-4N0M0 or T (any) N1-3M0, with good performance status, normal blood and renal function were treated with capecitabine 825 mg/m2 12/12hs during radiotherapy associated with a single dose of mitomycin 15 mg/m2 on Day 1. Primary objective is determine local control rate in 6 months with capecitabine, mitomycin and radiotherapy in patients with SCC of the anal canal. After the end of the treatment patients were reassessed for clinical and radiological response. Sample size was calculated using Fleming's single stage. Considering 85% of expected events (rate of local control in 6 months), standard deviation and a 5% error, sample size calculated was 51 patients. Results: 13 patients have been included, 9 patients have finished, 3 patients are still in treatment and 1 patient was excluded because of poor compliance with oral medications. Regarding the staging, 5 patients (38,4%) with stage II, 4 patients ( 30,8%) with stage IIIA and 4 patients (30,8%) with stage IIIB. Among patients who finished the treatment and were reevaluated 1 patient ( 16,7%) presented partial clinical response, 6 patients (83,3%) had clinical complete response. Three patients are waiting for clinical and radiologic reassessement. The main toxicities observed were grade I diarrhea ( 30,7%), grade II (38,5%) and III (30,7%) radiodermitis, nausea ( 38,5%), grade I-II plaquetopenia( 30,7%). Grade I hand–foot syndrome was observed in 1 patient and hemorrhagic cystitis related to radiotherapy was observed in 1 patient. No serious adverse event was observed. Colostomy was required in 1 patient before the beginning of the treatment. Conclusions: The study is ongoing but capecitabine and mytomicin with radiotherapy seem to be a safe treatment for SCC of the anal cancer.