Unresectable or recurrent gastric cancer
Conditions
Interventions
A: Oral S-1, 80 mg/m2 twice daily for 3 weeks followed by 2-week rest combined with intravenous cisplatin 60 mg/m2 given on day 8 every 5 weeks, until disease progression or unmanageable toxicity
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological confirmed adenocarcinoma; papillary, tubular, poorly, signet ring cell, mucinous, or hepatoid 2) unresectable advanced or recurrent gastric cancer 3) No massive ascites 4) No evidence of central nervous system metastasis 5) Measurable or non-measurable disease 6) Able to eat or drink 7) Aged >20 and <75 8) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 or 1 9) HER2 negative, or unknown at registration 10) No previous chemotherapy, radiotherapy, or hormone therapy except post-operative adjuvant chemotherapy with S-1 alone as long as it was completed at least 24 weeks prior to randomization, or either pre- or post-operative adjuvant chemotherapy with platinum, which includes cisplatin plus S-1, oxaliplatin plus S-1, or oxaliplatin plus capecitabine, with less than 180 mg/m2 of a total dose of cisplatin or 1040 mg/m2 of oxaliplatin, as long as it was completed at least 24 weeks prior to randomization 11) Adequate organ function: i) Neutrophil >1,500/mm3 ii) Platelet >100,000/mm3 iii) Total bilirubin <1.5 mg/dL iv) AST<100 IU/L(<200 IU/L in patients with liver metastasis) v) ALT<100 IU/L(<200 IU/L in patients with liver metastasis) vi) Serum creatinine<1.5 mg/dL 12)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Multiple primary cancers with disease-free period less than 5 years, except carcinoma in situ or intra mucosal disease cured by local therapy 2) Active infection 3) Fever more than 38c 4) Pregnant, unwilling to practice contraception during the study, or lactating female 5) Uncontrolled psychiatry disease 6) Chronic daily treatment with oral or intravenous corticosteroids 7) Uncontrolled diabetes mellitus or chronic daily treatment with insulin 8) Unstable angina, or past history of myocardial infarction in 6 months 9) Evidence of any other serious disease; renal failure, hepatic failure, interstitial pneumonitis or lung fibrosis 10) Active bleeding 11) Massive pleural effusion, more than half of thoracic space at least one-side
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint: overall survival in differentiated or undifferentiated adenocarcinoma Other secondary endpoints: progression free survival, response rate, dose intensity, adverse events, grade4 non-hematologic toxicity, early death, toxicity-related death, progression free survival and response rate in differentiated or undifferentiated adenocarcinoma | — |
Countries
Japan
Contacts
Public ContactYasuhide Yamada
JCOG1013 Coordinating Office National Cancer Center Hospital
Outcome results
None listed