Gastric neoplasm
Conditions
Interventions
A: Surgery alone
B: Surgery followed by chemotherapy with S-1
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma 2) Pathological stage II/III defined by 14th edition of Japanese Classification of Gastric Carcinoma 3) Received R0 gastrectomy with D1+ or D2 lymphadenectomy 4) Either of the following surgery performed; i) Open laparotomy regardless of clinical stage and type of gastrectomy ii) Laparoscopic or laparoscope-assisted distal, pylorus preserving, total or proximal gastrectomy for clinical stage I 5) Either of the followings: i) Weight loss < 15% and 30 mL/min <= Ccr for the patients received total gastrectomy ii) Weight loss < 15% and 30 mL/min <= Ccr < 80 mL/min for the patients not received total gastrectomy 6) Within 5 to 7 weeks after surgery 7) Aged 80 years old or older 8) Performance status of 0 or 1 9) No gastric stump cancer 10) No previous treatment of chemotherapy, radiation therapy, or molecular-target therapy for any neoplasms. (History of hormone therapy more than one year ago is eligible.) 11) Enough oral intake 12) No dementia, or dementia with family support to continue protocol treatment or examinations 13) Sufficient organ functions 14) No ischemic change on ECG 15) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shorter 2) Infectious disease requiring systemic treatment 3) Body temperature of 38 degrees Celsius or higher 4) Severe mental disease 5) Requiring systemic steroid medication (>= 5 mg/day of prednisolone) 6) Under treatment by flucytosine, phenytoin, or warfarin potassium 7) Uncontrolled diabetes mellitus 8) Uncontrolled hypertension 9) Unstable angina pectoris (angina developed or attack worsened within recent 3 weeks) or previous myocardial infarction within 6 months 10) Positive for HBs antigen 11) Severe interstitial pneumonia, severe lung fibrosis, or severe emphysema 12) Surgical morbidity such as infection, leakage, intestinal bleeding, pancreatic fistula, and so on is not improved
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival, time-to-treatment-failure, proportion of treatment continuation, relative dose intensity, adverse events, severe adverse events | — |
Countries
Japan
Contacts
Public ContactKazuya Yamaguchi
JCOG1507 Coordinating Office Gifu University Hospital, Gifu Municipal Hospital
Outcome results
None listed