A Phase II open- labeled, prospective study to determine the efficacy of pre-operative
chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME)
followed by an additional six cycles of FOLFOX 6.
The objectives of this study are the following:
1. The primary endpoint of this trial is pathologic complete response (response rate).
2. Secondary endpoints will include observation of overall pathologic response rate,
correlation of pathologic staging with pre-operative ultrasound and pelvic MRI staging,
as well as observation of toxic side effects, patterns of disease relapse, disease-free
survival outcomes and overall survival outcomes.