Genetic and Epigenetic Determinants of Response to Fluorouracil-based Adjuvant Chemotherapy in Patients With Stage III Colorectal Cancer

Other illness

• Patients with a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to fluorouracil.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection-requiring intravenous antibiotics, or psychological, familial, sociological, or geographical condition that would limit compliance with study requirements
• Following cardiovascular conditions within the past 6 months: Myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia, cerebrovascular accident or transient ischemic attack, deep vein thrombosis, other significant thromboembolic event.
• Known human immunodeficiency virus (HIV)-positive patients and those with known hepatitis B or C.
• Patients with evidence of other primary malignancies within the past 5 years, excluding adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.

Other

• Pregnant or nursing.

• Requirements for tumor parameters
  • Histologically confirmed colorectal adenocarcinoma.
  • Stage III disease (any pT, N1-2, M0).
  • Tumors must have been curatively resected (R0).
  • No evidence of residual involved lymph node disease or metastatic disease at the time of registration.
• Requirements for patient characteristics
  • Patient is ≥ 18 years of age on the day of consenting to the study.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 at the time of screening.
  • Fertile patients must use effective contraception.
  • Patients must demonstrate ability to understand and the willingness to sign a written informed consent document.
  • Patients must demonstrate ability to complete study questionnaires.
  • Patients must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
• Required initial laboratory values
  • Leukocytes ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total Bilirubin ≤ 1.5 times ULN
  • Aspartate aminotransferase (AST) ≤ 2.5 times ULN
  • Alanine aminotransferase (ALT) ≤ 2.5 times ULN