HER2 positive gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis.
Conditions
Interventions
Preoperative chemotherapy with S-1 plus cisplatin followed by D2 or D2+No.16 gastrectomy and postoperative chemotherapy with S-1 treatment for a year.
Preoperative chemotherapy with trastuzumab combin
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven primary gastric adenocarcinoma. 2) HER2 positive (IHC 3+ or IHC 2+ and ISH +). 3) Contrast-enhanced abdominal computed tomography (CT) revealed at least one of the following: i. Para-aortic lymph node enlargement >=1.0 cm in major axis between the upper margin of the celiac artery and the upper border of the inferior mesenteric artery (No. 16a2/ 16b1) ii. Bulky lymph nodes (>=3 cm 1or>=1.5 cm 2 in major axis) along the celiac, splenic, common or proper hepatic arteries, or the superior mesenteric vein iii. T2-T4 disease with enlarged regional lymph node (>= 1.5 cm in minor axis) 4) Contrast-enhanced thoracic/abdominal/pelvic CT revealed no metastatic lesion other than the lymph node metastasis. 5) The macroscopic tumor type is neither Borrmann type 4 (linitis plastica) nor large (8 cm or more) type 3 6) No esophageal invasion or an invasion of 3 cm or less 7) No gastric stump cancer 8) No prior chemotherapy, radiotherapy, or endocrine therapy for any malignancies. 9) No prior surgery for gastric carcinoma except bypass surgery and endoscopic resection 10) A staging laparoscopy or laparotomy performed within 28 days before registration revealed negative washing cytology and no peritoneal metastasis 11) Aged 20 to 75 years old. 12) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 13) LVEF (Left ventricular ejection fraction) >= 50% by ultrasound cardiography. 14) 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. Creatinin <= 1.3 mg/dL viii. CCr >= 60mL/min/body 15) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Active infection requiring systemic therapy. 3) Body temperature >= 38 degrees Celsius. 4) Pregnancy, possible pregnancy or breastfeeding. 5) Psychiatric disease. 6) Patients requiring systemic steroid medication. 7) Positive HBs antigen 8) Under treatment with flucytosine, phenytoin, or warfarin. 9) Interstitial pneumonia, pulmonary fibrosis or severe emphysema. 10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months. 11) Poorly controlled hypertension. 12) Poorly controlled diabetes mellitus or routine administration of insulin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, response rate of preoperative chemotherapy, proportion of patients with R0 resection, proportion of patients who complete the preoperative chemotherapy and surgery, proportion of patients who complete the protocol treatment, pathological response rate, proportion of adverse events and proportion of severe adverse events. | — |
Countries
Japan
Contacts
Public ContactMasanori Tokunaga
JCOG1301C Coordinating Office Division of Gastric Surgery, Shizuoka Cancer Center
Outcome results
None listed