Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer

Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.

This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.

Inclusion Criteria:

• histologically verified colorectal cancer
• clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
• age: 18-70 years
• ECOG 0-2
• adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
• no prior cancer and/or chemotherapy
• signed informed consent

Exclusion Criteria:

• patients with a history of prior malignancy
• pregnant or lactating patients
• known or suspected brain metastasis