Gastric cancer
Conditions
Interventions
S-1+CDDP therapy (S-1 80-120 mg day 1-21, CDDP 60 mg/m2 day 8) was repeated until the completion of 2 cycles every 5 weeks in unresectablly advanced, recurrent gastric cancer, and every 4 weeks in adv
=1.5 L on days 9-10 of each cycle, and they take antiemetics orally on days 9-11, and they also take diuretics orally as needed.
In inpatient arm, patients are administered intravenous hydration on da
Sponsors
National Cancer Center Hospital
Aichi Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unresectablly advanced, recurrent gastric cancer patients or advanced gastric cancer who require neoadjuvant chemotherapy. 2) Histologically confirmed primary gastric cancer. 3) Performance status (ECOG) of 0, 1, or 2. 4) Age between 20 and 75 years. 5) Estimated to be able to take oral hydration >=1.5L/day. 6) Adequate organ function confirmed by laboratory data below (within 2 weeks before registration). Neutrophil >=1200/mcl Hb >=8.0g/dl Plt >=75000/mcl T-Bil <=3.0mg/dl GOT <=100IU/l GPT <=100IU/l Cr <=1.5mg/dl or estimated Ccr >=50ml/min 7) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity to S-1 or CDDP. 2) Receiving fluoropyrimidine preparation. 3) Receiving systemic steroid therapy. 4) Required to continue to take flucytosine, phenytoin, and warfarin. 5) Severe complications (ileus, bowel obstruction, interstitial lung disease, uncontrolled diabetes, severe arrhythmia, heart failure, renal failure, liver cirrhosis, active hepatitis, and so on). 6) Active ischemic heart disease. 7) Woman who are pregnant, lactating, or willing to get pregnant, or man who are willing to have unprotected intercourse. 8) Severe mental disorder. 9) Regarded as inadequate physical conditions by attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion proportion of 2 cycles in outpatient arm | — |
Secondary
| Measure | Time frame |
|---|---|
| Completion proportion of 2 cycles in inpatient arm, completion proportion of 2 cycles in all patients, progression free survival, proportion of incidence of adverse events in outpatient arm, inpatient arm, and all patients | — |
Countries
Japan
Contacts
Public ContactShunsuke Okazaki
National Cancer Center Hospital Gastrointestinal Oncology Division
Outcome results
None listed