Gastric cancer
Conditions
Interventions
Arm A: gastrectomy with D2 lymph node dissection and postoperative chemotherapy with S-1 for one year
Arm B: preoperative chemotherapy with S-1 (80-120 mg/body, p.o., day 1-14) plus oxaliplatin (130 m
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma. 2) Clinical T3/T4 by imaging. 3) No tumor invasion to pancreas head from primary tumor and/or metastatic lymph node 4) Enlarged lymph node (>=8mm in minor axis or >=10mm in major axis) by contrast-enhanced abdominal computed tomography (CT). 5) No bulky lymph nodes (>=3 cm x 1 or >=1.5 cm x 2 in major axis) along the celiac, splenic, common or proper hepatic arteries, or the superior mesenteric vein by contrast-enhanced abdominal computed tomography. 6) Both of HER2 positive and negative patients. HER2 negative has to be confirmed in patients with enlarged lymph node of 15mm in minor axis. 7) No distant metastasis based on contrast-enhanced thoracic/abdominal/pelvic CT. 8) The macroscopic tumor type is neither Borrmann type 4 (linitis plastica) nor large (8 cm or more) type 3. 9) No esophageal invasion or an invasion of 3 cm or less. 10) No gastric stump cancer. 11) When a staging laparoscopy is performed before registration, non-curable factors other than positive lavage cytology are not revealed. 12) Sufficient oral intake. 13) No prior chemotherapy, radiotherapy, or endocrine therapy for any malignancies within five years. 14) Aged between 20 and 79 years old. 15) Eastern Cooperative Oncology Group performance status of 0 or 1. 16) Sufficient organ function. i. Neutrophil >= 1,500/mm3 ii. Hb >= 8.0 g/dL iii. Platelet >= 100,000/mm3 iv. T.Bil <= 2.0 mg/dL v. AST <= 100 IU/L vi. ALT <= 100 IU/L vii. Creatinine <= 1.3 mg/dL viii. CCr >= 60mL/min/body 17) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Body temperature of 38 degrees Celsius or higher. 4) During pregnancy, within 28 days of postparturition, or during lactation. 5) Severe mental disease. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) Under treatment with flucytosine, phenytoin, or warfarin. 8) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 9) Poorly controlled diabetes. 10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, response rate of preoperative chemotherapy by RECIST ver1.0, proportion of R0 resection, proportion of completion of surgery, proportion of completion of protocol treatment, pathological response rate, toxicities, dose intensity of preoperative chemotherapy, proportion of patients undergoing postoperative chemotherapy at 3, 6, 9, and 12 months after surgery | — |
Countries
Japan
Contacts
Public ContactMasanori Tokunaga
JCOG1509 Coordinating Office Division of Gastric Surgery, Shizuoka Cancer Center
Outcome results
None listed