gastric neoplasm
Conditions
Interventions
arm A:8 courses of S-1 adjuvant chemotherapy
arm B:4 courses of S-1 adjuvant chemotherapy
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Gastric adenocaricinoma diagnosed pathologically (limited to the common type defined by the histological classification of the 14th edition of Japanese Classification of Gastric Carcinoma) 2) Pathological stage II defined by 14th edition of Japanese Classification of Gastric Carcinoma 3) Performance status of 0 or 1 4) Received R0 gastrectomy with lymph node dissection which fulfills either of the following conditions; i) D1+ or D2 lymphadenectomy for clinical stage Ia, ii) D2 lymphadenectomy for clinical stage Ib, iii) Spleen-preserving total gastrectomy with modified D2 lymphadenectomy without nodal dissection of #10 or #10/#11d 5) 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 6) Within 7 weeks after surgery 7) Age from 20 to 80 years old 8) No gastric stump cancer 9) No previous treatment of chemotherapy, radiation therapy, or molecular-targetting therapy for any neoplasms. (History of hormone therapy more than one year ago is eligible.) 10) Enough oral intake 11) Preserved organ function as follows; i) neutrophile count >=1,200/mm3 ii) hemoglobin >=8.0 g/dL iii) platelet count >=75,000/mm3 iv) AST=<100 IU/L v) ALT=<100 IU/L vi) total bilirubin =<2.0 mg/dL vii) creatinine clearance (CCr) >=60 mL/min in case of body surface area >=1.25m2 or CCr >=40mL/min in case of body surface area < 1.25m2 12) 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 shoter, except for following;; prostate cancer with clinical stage I and completely resected following cancers; gastric cancer (adenocarcinoma) with stage 0-I, colon cancer (adenocarcinoma) with stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma) with stage 0, breast cancer (noninvasive ductal carcinoma and noninvasive lobular carcinoma) with stage 0 and breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, and Paget disease) with stage 0-IIA, endometrial cancer (endometrioid adenocarcinoma and mucinous adenocarcinoma) with stage I, prostate cancer (adenocarcinoma) with stae I-II, cervical cancer (squamous cell carcinoma) with stage 0, thyroid cancer (papillary carcinoma and follicular carcinoma) with stage I-III, and renal cancer (clear cell carcinoma and chromophobe cell carcinoma) with stage I. 2) Infection requiring systemic treatment 3) Body temparature >=38c 4) Surgical morbidity such as infection, leakage, intestinal bleeding, pancreatic fistula, and so on is not improved 5) Women expecting pregnancy, in pregnancy, in possible pregnancy or in breast feeding 6) Male expecting partner's pregnancy 7) Severe mental disease 8) Under treatment by flucytosine, phenytoin, or warfarin potassium 9) Requiring systemic steroid medication (>= 5 mg/day of prednisolone) 10) Uncontrolled diabetes mellitus 11) Uncontrolled hypertension 12) Unstable angina pectoris (angina developed or attack worsened within recent 3 weeks) or previous myocardial infarction within 6 months 13) Positive for HBs antigen or HCV antibody 14) Interstitial pneumonia, lung fibrosis, or severe emphysema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Time-to-treatment-failure, adverse events, adverse events observed from 9 to 12 months after surgery, grade 4 non-hematological adverse events, early death, treatment-related death | — |
Countries
Japan
Contacts
Public ContactTakaki Yoshikawa, M.D.
JCOG1104Coordinating Office Department of Gastrointestinal Surgery, Kanagawa Cancer Center
Outcome results
None listed