Randomization and procedure protocol
stomatitis, malignancy, death, Cancer
ADVERSE EVENT, RECURRENCE, STOMATITIS, ADVERSE EVENTS, ADVERSE EVENT, DISEASE, EVENT, CANCER
The anaesthetic evaluation and patient information regarding the operative procedure were performed according to the local practices of each investigation centre. Radical surgery was performed as per the oncological quality criteria for resection. Preoperative and postoperative data were reported on specific forms. If the histological assessment confirmed stage III disease and the patient met the inclusion criteria, eligible patients were randomly assigned (1 : 1) to the EAC arm or the CAC arm. The randomization sequence was concealed from the investigators, and randomization was performed using a web-based software platform (Velos, Fermont, CA, USA) and centrally coordinated by the Clinical Research Coordination Centre of the Kyungpook National University Cancer Centre (Daegu, Korea).The assigned AC was delivered between postoperative day (POD) 10 and 14 in the EAC arm, and between POD 24 and 28 in the CAC arm. The AC regimen was FOLFOX, which comprised oxaliplatin 85 mg/mToxicity was evaluated based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0, and dose modifications were based on the most severe adverse events and the investigator’s discretion. Adverse events were monitored during and after the study treatment, and a complete laboratory examination was performed on day 1 of each treatment cycle. For treatment-related adverse events of grade 1, treatment was continued at the total dose. For grade 2, treatment was withheld and restarted after recovery to grade 1. The dose was reduced for grade 3 adverse events and grade 4 stomatitis with a delay in the treatment schedule, if necessary. Treatment was discontinued in the event of any documented disease recurrence, grade 4 or 5 adverse events, or a patient’s refusal.After completing the protocol treatment, patients were followed up according to a predefined surveillance schedule until recurrence, development of another malignancy, or death. Carcinoembryonic antigen level assessment with a general blood test and abdominopelvic CT scans were performed every 3 to 6 months for the first 2 years and every 6 months thereafter. Chest CT scans were performed every 8 to 12 months. A colonoscopy was routinely performed 1 year and 5 years after surgery.