Gastric Cancer
Conditions
Interventions
TS-1:dosage 80mg/m2, take orally 3weeks, and 2 weeks rest CDDP:60mg/m2, the intravenous drip infusion on the 8 days CPT-11:the intravenous drip infusion on the 8 and 22 days One course lasts 5 week
Sponsors
Osaka Gastroestinal cancer chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)gastric cancer proven histologically Cancers located within 2-3cm of E-G junction are eligible. 2)Unresectable advanced gastric cancer (Stage IV) Cancers with metastatic lymph nodes of para-aortic a2 or b1 station are excluded. 3)with measurable lesions by RECIST version 1.1 4)HER2(-) or unknown HER2 5)patients between 20 and 75 years old at registration 6)PS (ECOG) between 0 and 1 7)without prior chemotherapy and/or radiation therapy 8)without any ascites and/or thoracic fluid to be removed 9)without any brain metastasis 10)with a good condition of important organs within 14 days of registration a)WBC >= 3,500/mm3 b)neutrophil >= 2,000/mm3 c)platelet >= 100,000/mm3 d)AST/ALT < 100 IU/L < 200 IU/L for patients with liver metastasis e)total bilirubin < 1.5mg/dL f)serum creatinine <= 1.2mg/dL g)Creatinin clearance >= 60ml/min CC by Cockcroft-Gault method is available 11)patients who can eat orally 12)expected survival longer than 3 months 13)written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1)with active double cancers whose disease free period is shorter than 5 years Carcinoma in situ can be included 2)with a history of severe allergy against medicines 3)with severe diarrhea (more than 4 times/day) or watery stool 4)with body temperature over 38 degrees Celsius and/or infectious disease which needs therapy 5)with severe myelo-dysfunction, renal dysfunction and/or liver dysfunction 6)with other sever diseases a)interstitial pneumonitis, pulmonary fibrosis or severe emphysema b)cardiac failure, cardiac infarction, angina pectoris c)renal dysfunction d)liver dysfunction e)intestinal paralysis, ileus f)jaundice g)uncontrolled DM 7)with HBs (+) 8)patients whom administered Flucitosine or Athazanavil sulfate 9)patients whom administered Fenitoin and/or Warfarin 10)general administration of steroids 11)women who are pregnant or expect to be pregnant, or nursing female 12)patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms 13)patients whom doctor in chief decides not to register to this study due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose and recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate (RR) Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactHiroshi Furukawa
Kinki University School of Medicine Department of surgery
Outcome results
None listed