Study design and participants
AJCC Cancer, tumours, malignancy, colorectal surgeons, non-cancer-related disease, perforation, tumour obstruction, hypersensitivity, unresectable disease
ADENOCARCINOMA OF THE COLON, TUMOURS, POSTOPERATIVE COMPLICATIONS, COLON CANCER, CANCER; METASTATIC, ONCOLOGY, STAGE II COLON CANCER, HYPERSENSITIVITY
A multicentre, randomized (1 : 1), open-label, phase III trial was conducted comparing EAC with CAC in patients with stage III colon cancer. Patients were recruited from eight centres in South Korea. All centres were tertiary medical institutes with sub-specialist colorectal surgeons. Patients with stage III colon cancer were screened after surgery to determine whether they met the inclusion criteria: age greater than or equal to 18 years with Eastern Cooperative Oncology Group (ECOG) performance status 0–2; histologically confirmed adenocarcinoma of the colon (tumours greater than 12 cm from the anal verge or above the peritoneal reflection); undergone standard, minimally invasive, curative R0 resection with D3 lymphadenectomy; discharged within 10 days after surgery; stage III based on the Seventh Edition of the AJCC Cancer Staging Manual; fully recovered hepatic, renal, and haematological function, as assessed by serum chemistry with calculated creatinine clearance, liver function test, and full blood cell count; and able to understand and willing to consent. The main exclusion criteria were: rectal cancer; metastatic or radically unresectable disease; stage I or II colon cancer based on the Seventh Edition of the AJCC Cancer Staging Manual; any contraindication for chemotherapy, including age greater than 85 years or life expectancy under 5 years due to non-cancer-related disease; hypersensitivity to treatment component(s); unable to be discharged 10 days after surgery due to any postoperative complications; emergency operation for tumour obstruction or perforation; history or presence of synchronous malignancy; previous chemotherapy; and being pregnant or breastfeeding.The study was conducted as per the Declaration of Helsinki and the Good Clinical Practice guidelines. The study protocol was approved by the Kyungpook National University Hospital Ethics Committee (version 1.3) on 21 January 2012, and its equivalent in other participating institutions. All participants provided written informed consent before enrolment. Trial oversight was maintained by a combined trial steering committee and a data monitoring committee. This study was registered at ClinicalTrials.gov (NCT01460589).