Neoadjuvant FOLFOXIRI Chemotherapy Alone for Locally Advanced Rectal Cancer (FORTUNE)

Inclusion Criteria

• Diagnosis of adenocarcinoma of the rectum
• Age: 18-70 years old
• Signed informed consent; able to comply with study and/or follow- up procedures
• Stage of the primary tumor may be determined by ultrasound or MRI
• Stage II (T3-4, N0 [N0 is defined as all imaged lymph nodes < 1.0 cm]) OR stage III (T1-4, N1-2 [with the definition of a clinically positive lymph node being any node ≥ 1.0 cm]
• Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope
• Distal border of the tumor must be located < 12 cm from the anal verge
• Tumor amenable to curative resection
• Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
• Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL.
• Total bilirubin ≤1.5 x the upper limit of normal (ULN).
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
• Alkaline phosphatase limit ≤ 5x ULN.
• Amylase and lipase ≤ 1.5 x the ULN.
• Serum creatinine ≤ 1.5 x the ULN.
• Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.
• No renal disease that would preclude study treatment or follow-up
• ECOG status: 0～1

Exclusion Criteria:

• Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
• No More than 4 weeks since prior participation in any investigational drug study
• More than 4 weeks since prior participation in any investigational drug study
• Clear indication of involvement of the pelvic side walls by imaging
• With distant metastasis
• History of invasive rectal malignancy, regardless of disease-free interval
• Fertile patients must use effective contraception
• Uncontrolled hypertension
• Cardiovascular disease that would preclude study treatment or follow-up
• Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
• Synchronous colon cancer
• Pregnant or nursing, Fertile patients do not use effective contraception
• Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
• No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
• patients refused to signed informed consent.