Clinical trial NCT02887313 (phase 2, status: recruiting)
Conditions: rectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: mfolfox6
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        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.