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Background: The purpose of this study was to examine the efficacy and tolerability of the combination of oxaliplatin, capecitabine, and radiotherapy in patients with locally advanced rectal cancer. Methods: Eighteen patients with clinically locally advanced and/or inoperable rectal cancer received 45-50.4 Gy of radiotherapy with concomitant weekly oxaliplatin 60 mg/m2 and capecitabine 750 mg/m2 bid for 5 days/week followed by definitive resection or exploratory laparotomy. Results: Seventeen of the 18 subjects had complete (R0) resection. High-grade pathologic response was observed in 17 of the 18 patients, and downstaging and complete pathologic response was recorded in 78% and 22% of patients respectively. Survival and relapse-free survival at 3 years were 78% and 61% respectively. Treatment-related toxicities were manageable with no grade IV toxicities, and grade III anemia, urinary frequency, tenesmus, and diarrhea, alone or in combination, were seen in four patients. Conclusion: Preoperative radiotherapy in combination with oxaliplatin/capecitabine is active in patients with locally advanced rectal cancer, producing near-universal high-grade tumor pathologic response, significant tumor downstaging and downsizing, and high rate of complete resection with intriguing 3-year survival data. The current study regimen has a favorable toxicity profile and warrants further evaluation in a larger trial. [ABSTRACT FROM AUTHOR]