Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer

OBJECTIVES: Primary * To assess the complete pathologic response rate in patients with rectal cancer treated with radiation, modified neoadjuvant FOLFOX 6 chemotherapy followed by total mesorectal excision and adjuvant modified FOLFOX 6 chemotherapy. Secondary * To observe the overall pathologic response rate in these patients. * To correlate pathologic staging with preoperative ultrasound and pelvic MRI staging. * To assess toxic side effects of these regimens in these patients. * To assess patterns of disease relapse, disease-free survival outcomes, and overall survival outcomes of these patients. OUTLINE: Patients with stage II/III rectal cancer were treated with OXA 60mg/m2 weekly continuous infusion 5FU of 225 mg/m2/d d1-5 with pelvic RT of 1.8Gy/d for 28 doses. Adjuvant therapy consisted of 6 cycles of biweekly FOLFOX6. Surgery: Patients undergo total mesorectal excision by anterior resection or an abdominal perineal resection within 4 weeks after completion of neoadjuvant therapy. Adjuvant therapy: Within 4 weeks after surgery, patients receive modified FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium IV over 2 hours on day 1 and continuous fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients complete quality of life assessment questionnaires at baseline and at each follow-up visit. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.