Gastric cancer
Conditions
Interventions
investigational material(s)
Generic name etc : TS-1(tegafur + gimeracil + oteracil potassium), CDDP(cisplatin), TSU-68
INN of investigational material : TS-1:tegafur,gimeracil,oteracil potassium, CDDP
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 a
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.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 1)Contraindication to TS-1 or CDDP. 2)Severe complications. 3)Colon disorder with active inflammation. 4)History of severe thrombosis or embolism. 5)Active double cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival RECIST v1.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Response rate, Pharmacokinetics, Overall survival CTCAE v3.0 | — |
Outcome results
None listed