Elderly patients with metastatic gastric cancer
Conditions
Interventions
5-week cycle of intravenous cisplatin (30-60 mg/m2 on day 8) and oral administration of S-1(25-60mg, twice a day, between days 1 and 21)
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven adenocarcinoma (papillary, tubular, or poorly differentiated), signet ring cell carcinoma, mucinous adenocarcinoma, or hepatoid adenocarcinoma 2) Unresectable advanced or recurrent disease 3) Age over 76 years 4) ECOG performance status (PS) of 0 or 1 5) No previous chemotherapy, or radiotherapy except post-operative adjuvant chemotherapy with fluoropyrimidine alone or fluoropyrimidine/leucovorin as long as it was completed at least 24 weeks prior to registration, or either hormone therapy as long as it was completed at least 24 weeks prior to registration 6) Adequate food intake 7) Negative HER2 status 8) Adequate organ function as defined below: a) Neutrophil count >= 1,500 /mm3 b) Platelet count >= 100000 /mm3 c) Total bilirubin =< 1.5 mg/dL d) AST =< 100 IU/L (<200 IU/L in patients with liver metastasis) e) ALT =< 100 IU/L (<200 IU/L in patients with liver metastasis) f) Serum creatinine =< 1.5 mg/dL and Ccr >= 30mL/min 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 2) Body temperature >= 38C 3) Severe mental disease 4) Current treatment with systemic steroids 5) Uncontrolled diabetes mellitus 6) Unstable angina pectoris within the past 3 weeks, or previous myocardial infarction within the past 6 months 7) Evidence of any other serious disease; renal failure, hepatic failure, interstitial pneumonia, or pulmonary fibrosis 8) Active bleeding 9) Massive ascites 10) Massive pleural effusion 11) Judged ineligible by the clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, progression-free survival, time to treatment failure, adverse events | — |
Countries
Japan
Contacts
Public ContactSatoru Iwasa
National Cancer Center Hospital Gastrointestinal Oncology Division
Outcome results
None listed