A Study of Neoadjuvant Chemoradiotherapy With 5-FU/Leucovorin (FL) vs. TS-1/Irinotecan in Patients With Locally Advanced Rectal Cancer

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the rectum
• AJCC/UICC pathologic stages of cT3-4 or cN plus
• Male or female patients, 18 years of age or older
• Be ambulatory and have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• No prior chemotherapy, radiotherapy and immunotherapy
• Adequate major organ functions as following: Hematopoietic function: ANC (absolute neutrophil count)1,500/mm3, Platelet 100,000/mm3, and Hepatic function: serum bilirubin < 1.5 x ULN, AST/ALT levels < 2.5 x ULN, and Renal function: serum creatinine < 1.5 x ULN or Ccr 50 ml/min by Cockcroft formula
• Be willing and able to comply with the protocol for the duration of the study.
• Give written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

• Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease
• Patients treated with previous surgery, chemotherapy and/or radiotherapy
• Uncontrolled or severe cardiovascular disease: New York Heart Association class III or IV heart disease, and Unstable angina or myocardial infarction within the past 6 months, and History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality.
• Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
• Other malignancy within the past 5 years except non-melanomatous skin cancer or carcinoma in situ of the cervix.
• Organ allografts requiring immunosuppressive therapy.
• Psychiatric disorder or uncontrolled seizure that would preclude compliance.
• Pregnant, nursing women or patients with reproductive potential without contraception.
• Patients receiving a concomitant treatment with drugs interacting with 5-FU or irinotecan such as flucytosine, phenytoin, or warfarin et al.
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency.
• Known hypersensitivity to any of the components of the study medications.
• Received any investigational drug or agent within 4 weeks before beginning treatment with study drug.