A randomized phase II trial of TSU-68 in patients with advanced gastric cancer

INTERVENTION: Intervention name : TS‐1(tegafur + gimeracil + oteracil potassium), CDDP(cisplatin), TSU‐68 INN of the intervention : TS‐1:tegafur,gimeracil,oteracil potassium, CDDP:cisplatin, TSU‐68:orantinib Dosage And administration of the intervention : Treatment is repeated every 35 days as follows; TS‐1 is orally administered at 40 to 60 mg twice a day after meals on days 1‐21 followed by 14 days rest. CDDP is given as an intravenous infusion of 60 mg/m2 on day 8. TSU‐68 is orally administered at 200mg or 400mg twice a day after meals. Control intervention name : TS‐1(tegafur + gimeracil + oteracil potassium), CDDP(cisplatin) INN of the control intervention : TS‐1:tegafur,gimeracil,oteracil potassium, CDDP:cisplatin Dosage And administration of the control intervention : Treatment is repeated every 35 days as follows; TS‐1 is orally administered at 40 to 60 mg twice a day after meals on days 1‐21 followed by 14 days rest. CDDP is given as an intravenous infusion of 60 mg/m2 on day 8. CONDITION: Gastric cancer PRIMARY OUTCOME: Progression free survival SECONDARY OUTCOME: Safety, Response rate, Pharmacokinetics, Overall survival INCLUSION CRITERIA: 1)Histologically or cytologically proven unresectable or recurrent gastric adenocarcinoma. 2)Target lesions confirmed by Imaging‐based evaluation such as CT within 28 days before enrollment. 3)No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) for gastric cancer. 4)Adequate oral intake. 5)ECOG Performance Status of 0 to 1.