efficacy and safety of s-1 plus oxaliplatin in first-line treatment of ederly patients with advanced gastric cancer

Conditions: S-1 Plus Oxaliplatin

Summary: elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus s-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.

3-week plan of s-1 plus oxaliplatin has been widely used,but it also has cumulative toxicity.meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus s-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.untreated elderly patients with advanced or recurrent gastric cancer will receive oxaliplatin 85 mg/m2 (d1, q2w) and s-1(40mg bid for body surface area \ 1.5 m2; d1-10, q2w) as the first-line treatment. we will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in china.the primary endpoint is progression-free survival(pfs), and the secondary endpoints are objective response rate(orr), overall survival(os) and the safety.

Eligibility criteria:
inclusion criteria: * histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma; * aged≥60 * ability of oral administration; * ct or mri can be used to assess measurable or non-measurable lesions according to the criteria of response evaluation criteria in solid tumours (recist 1.1); * untreated * more than 12 months after the last adjuvant/neoadjuvant chemotherapy; * ecog=0-2; * available organ function: alt≤2.5xuln;ast≤2.5xuln;if patients have hepaticmetastasis,alt≤2.5xuln,ast≤2.5xuln;alp≤2xuln;tbil≤1.0xuln;neut≥1.5×109/l;plt≥100×109/l;hb≥90g/l;creatinine≤1.0xuln;creatinine clearance≥60ml/min * informed consent; * expected survival more than 3 months;more than 3 weeks after major surgery. exclusion criteria: * neoadjuvant and/or adjuvant have been treated with more than two plans; * in the past two years, the total dose of oxaliplatin≥800mg/m2; * other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer; * symptomatic brain metastases or soft meningeal metastasis; * myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; * serious complications (including intestinal paralysis, gastrointestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis); chronic nausea, vomiting or diarrhea (more than 4 times per day, or watery);gastrointestinal bleeding requires regular blood transfusion;hiv or aids; mental illness; neuropathy grade≥2;infectious diseases or inflammation, temperature≥38℃; * known allergy to drugs in the study; * pregnant or lactating women; * both male and female subjects of potential fertility have to agree effective birth control during the entire study; * experimental drugs used no more than 4 weeks; * other conditions the researchers considered ineligible for the study.

Keywords: s-1,oxaliplatin,advanced or recurrent gastric cancer