Patients will receive neoadjuvant chemotherapy for 4 months. Patients will undergo a CT scan at 8 weeks and 16 weeks after the start of neoadjuvant chemotherapy to assess treatment response. Patients without disease progression will then undergo AD-XRT for 15 to 25 fractions (3 to 5 weeks).
Patients will receive NALIRIFOX for a total of 4 months. NALIRIFOX will be administered on days 1 and 15 of a 4-week cycle for 4 cycles, until intolerable toxicity, or until the development of criteria for removal from the study.
Liposomal irinotecan: 50 mg/m2 IV over the course of 90 minutes (±10 minutes) on days 1 and 15 of every 4-week cycle.
Oxaliplatin: 60 mg/m2 IV over the course of 120 minutes (±10 minutes) on days 1 and 15 of every 4-week cycle.
Leucovorin: 400 mg/m2 IV over the course of 30 minutes (±5 minutes) on days 1 and 15 of every 4-week cycle.
5-FU: 2400 mg/m2 IV over the course of 46 hours (±60 minutes) on days 1 and 15 of every 4-week cycle
Combination Product: AD-XRT and Capecitabine
The interval between completion of induction chemotherapy and initiation of AD-XRT will be 2-6 weeks. The patient will be concurrently treated with capecitabine 825 mg/m2 BID PO Monday to Friday with radiation, as chemoradiotherapy is the standard approach at MSK.
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