Gastric carcinoma
Conditions
Interventions
S-1: 80mg/m2 twice a day oral intake on days 1-14 followed by 7 days rest. L-OHP: 130mg/m2 div. on day 1.
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically proven advanced/recurrent gastric adenocarcinoma with Her2-nagative or unknown 2) with measurable lesions by RECIST version 1.1 3) 20 years of age and older 4) Performance Status by Eastern Cooperative Oncology Group of 0 or 1 5) without any history of chemotherapy or radiation therapy and for recurrent cases, with longer than 6 months rest of adjuvant chemotherapy 6) with good functions of important organs by a data taken within 2 weeks at registration 1. Neutrophil: =>1,500/mm3 2.Platelet: =>100,000/mm3 3. Hemoglobin: =>8.0 g/dL 4. T.bil.: =<2.0 mg/dL 5. AST(GOT): =< 100 IU/L (=<200 IU/L in patients with liver metastasis) 6. ALT(GPT): =< 100 IU/L (=<200 IU/L in patients with liver metastasis) 7.SCr: =<1.5mg/dL 8. cleatinine clearance : =>50mL/min * CC by Cockcroft-Gault method is available 7) with an expected survival longer than 3 months 8) Patients able to take orally 9) with written Informed Consent
Exclusion criteria
Exclusion criteria: 1) With history of chemotherapy and/or radiation therapy 2) with active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval 3) with symptoms due to metastasis in the central nerve 4) have a history of severe drug hypersensitivity 5) with below comorbidity; 1. uncontrolled DM 2. uncontrolled hypertension 3. liver cirrhosis, hepatic failure 4. renal failure 5. interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema 6. with active infectious diseases 7. with a history of heart failure, cardiac infarction, angina pectoris and/or abnormal electrocardiogram within 6 months 6) HBs antigen positive 7) with active bleeding 8) with sensory neuropathy 9) with severe diarrhea (over 4 times a day or watery diarrhea ) 10) under medication of flucytosine phenytoin or warfarin 11) under continuous steroids medication 12) women pregnant and/or nursing or men who like to have children in future 13) patients with a psychological disease or symptoms whom physician in charge judges to be unable to participate 14) Any patients judged by the physician in charge to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Progression free survival (PFS) Time to Treatment Failure (TTF) Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactKazumasa Fujitani
Osala General Medical Center Department of surgery
Outcome results
None listed