Gastric cancer
Conditions
Interventions
Preoperative chemotherapy with Docetaxel, Oxaliplatin, and S-1 followed by gastrectomy with D2+No.16 lymph node dissection
Sponsors
Doki Yuichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma 2) HER2 negative has to be confirmed 3) Enhanced abdominal CT revealed having any of the followings: i) Paraaortic lymph node metastasis (No.16a2/ 16b1) ii) Bulky lymph node (>=3cmx1 or >=1.5cmx2) iii) Both of No.16a2/ 16b1 and Bulky lymph node 4) Enhanced thoracic/ abdominal/ pelvic CT revealed having no distant metastasis other than No.13 or No.16a2/ 16b1 lymph node metastasis 5) Neither Borrmann type 4 nor large (8cm or more) type 3 6) Length of esophageal invasion less or equal to 3cm 7) Not stump cancer of stomach 8) Clinically no sign of distant metastasis 9) Age between 20 and 75 at registration 10) Performance Status(ECOG) 0 or 1. 11) No peritoneal metastasis and CY0 by laparoscopy or laparotomy 12) Total gastrectomy with thoracotomy, left upper abdominal exenteration or Appleby's operation is not required to achieve the R0 resection 13) No prior treatment of chemotherapy or radiation therapy or endocrine therapy against any other malignancies 14) 1No prior surgery for gastric carcinoma except for bypass surgery and endoscopic resection 15) Fair oral intake with or without bypass surgery 16) Sufficient organ function. i. Neutrophil >= 2,000/mm3 ii. Hb >= 8.0 g/dL iii. Platelet >= 100,000/mm3 iv. T.Bil = 50mL/min/body 17) Written informed consent from patient.
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 valve disease, dilated or hypertrophic cardiomyopathy 10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT 11) Poorly controlled diabetes 12) Poorly controlled hypertension 13) HBs antigen positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, progression-free survival in patients with R0 resection, proportion of R0 resection, response rate of preoperative chemotherapy by RECIST ver1.0, proportion of completion of surgery, proportion of completion of protocol treatment, toxicities | — |
Contacts
Public ContactYukinori Kurokawa
The University of Osaka Hospital
Outcome results
None listed