Efficacy of celecoxib for prevention of oxaliplatin related injection pain in patients with stage II/III colon cancer: a randomized phase II trial

INTERVENTION: Administration of the celecoxib no treatment CONDITION: colon cancer PRIMARY OUTCOME: incidence of at least grade 2 injection pain INCLUSION CRITERIA: (1) Histologically confirmed colon cancer. (2) Histological stage II or III colon cancer or rectosigmoid cancer resected with D2 or more lymph node dissection. (3) Able to start protocol treatment within 10 weeks of surgical procedure.(4) Age 20–80 years old. (5) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. (6) No prior chemotherapy or radiotherapy for target disease. (7) Preservation of primary organ function [white blood cell (WBC) count ≥3,000/mm3 and <12,000/mm3, neutrophil count ≥1,500/mm3, haemoglobin ≥8.0 g/dL, platelet count ≥100,000/mm3, aspartate aminotransferase, alanine aminotransferase (ALT) <100 IU/L, serum total bilirubin <1.5 mg/dl,serum creatinine <1.5 mg/dl, (8) After basic screening, informed consent to participate in the study was obtained from patients.