Three institutions participated in this study. The protocol was approved by the institutional review board of each participating institution. All the participating patients provided written informed consent, and the study was carried out in accordance with the Good Clinical Silybin B Practice guideline. A CONSORT diagram is provided in Fig.Patients were required to have the following criteria: histologically confirmed metastatic or recurrent gastric adenocarcinoma, chemotherapy naıve status, measurable or evaluable lesion, a performance status of 0 2 as determined by the Eastern Cooperative Oncology Group, and adequate organ function. Adjuvant and/or preoperative chemotherapy was allowed if more than six months had elapsed between the end of the therapy and the registration, but any prior therapy could not include S 1, capecitabine, or oxaliplatin.
Patients were excluded if they had brain metastasis, a neuropathy more than grade 2, or uncontrolled significant comorbid conditions.In the SOX arm, S 1 was administered orally at 80 mg/m2/day divided in two daily doses for 14 days, followed by a 7 day rest posaconazole clinical trial period in a 3 week schedule. In the CAPOX arm, capecitabine was administered orally at 2000 mg/m2/day divided in two daily doses for 14 days, followed by a 7 day rest period in a 3 week schedule. Oxaliplatin was administered at 130 mg/m2 intravenously in 2 h every 21 days in both arms. All the patients received prophylactic anti emetic medications. Treatment was delayed for up to 3 weeks when symptomatic toxicity persisted, and the ANC and platelet count were 1500/mm3 and 75,000/mm3, respectively.
In the event of grade 4 neutropenia, thrombocytopenia, or febrile neutropenia or grade 3 nausea/vomiting, diarrhoea, or stomatitis, the doses Itraconazole structure of oxaliplatin and S 1 or capecitabine were reduced by 25% starting from the next cycle. If grade 2 neuropathy was not resolved by the endof the cycle or grade 3 neuropathy occurred, the dose of oxaliplatin was reduced by 25% starting from the next cycle after recovering to grade 2 or less. Treatment was continued until one of the following events occurred: progression of the disease, withdrawal of consent by the patient, or unacceptable toxicity.Toxicity assessments, compliance with S 1 and capecitabine, and blood tests were done weekly during the first cycle and just before each cycle starting from the second cycle.
Tumour assessments Etoposide solubility were done every two cycles by the Response Evaluation Criteria in Solid Tumours version 1.0. Toxicity was assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0. All patients were asked to complete supply the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 on the first day of every other cycle and at the end of the treatment. The primary objective was the comparison between the SOX and CAPOX regimens using time to progression as a measure. This study was designed by a,pick the winner, format proposed by Liu et al.20 It was assumed that the median TTP of the inferior arm is 5 months with the hazard ratio of 1.3. Sample sizes for 1 year accrual and 90% correct selection probability were calculated as 117. Taking into consideration a 10% dropout rate, 65 patients per each arm were required to ensure .