gastric neoplasm
Conditions
Interventions
Preoperative chemotherapy with Docetaxel+CDDP+S-1 followed by gastrectomy with D2+No.16 lymph node dissection
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: "1) Histologically proven primary gastric adenocarcinoma. 2) 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 3) Enhanced thoracic/ abdominal/ pelvic CT revealed having none of the followings: i) Mediastinal lymph node metastasis ii) Lung metastasis iii) Peritoneal metastasis iv) liver metastasis v) Pleural effusion, ascites vi) Paraaortic No.16a1 or No.16b2 swelling 1cm or greater vii) Other distant metastasis 4) Neither Borrmann type 4 nor large (8cm or more) type 3. 5) Length of esophageal invasion less or equal to 3cm. 6) Not stump cancer of stomach. 7) Clinically no sign of cervical lymph node nor distant metastasis. 8) No peritoneal metastasis and CY0 by laparoscopy or laparotomy. 9) Age between 20 and 75 at registration. 10) Performance Status(ECOG) 0 or 1. 11) No prior treatment of chemotherapy or radiation therapy or endocrine therapy against any other malignancies. 12) No prior surgery for gastric carcinoma except for bypass surgery and endoscopic resection. 13) Fair oral intake with or without bypass surgery. 14) Adequate organ functions defined as indicated below; i) WBC >= 4,000/mm3 and <=12,000/mm3 ii) Neutrophil >= 2,000/mm3 iii) Hb >= 8.0 g/dL iv) Platelet >= 100,000/mm3 v) AST <= 100 IU/L vi) ALT <= 100 IU/L vii) T.Bil <= 1.5 mg/dL viii) Creatinin <= 1.5 mg/dL ix) CCr >= 60mL/min/body 15) Written informed consent from patient."
Exclusion criteria
Exclusion criteria: "1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal cancer. 2) Women during pregnancy or breast-feeding. 3) Severe mental disease. 4) Under treatment with systemic steroid. 5) HBs antigen positive. 6) Under treatment with flucytosine, phenytoin, or warfarin. 7) Allergy to iodine. 8) History of hypersensitivity to DOC, CDDP, or polysorbate 80. 9) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason. 10) Edema of limbs and trunk by any reason. 11) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 12) Active bacterial or fungal infection. 13) Past history of myocardial infarction or unstable angina pectoris within 6 months. 14) Uncontrollable hypertension. 15) Uncontrollable diabetes mellitus or routine administration of insulin."
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate of preoperative chemotherapy by RECIST ver1.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year survival, 5-year survival, proportion of R0 resection, proportion of completion of surgery, proportion of completion of protocol treatment, pathological response rate, toxicities | — |
Countries
Japan
Contacts
Public ContactSeiji Ito
JCOG1002 Coordinating Office Aichi Cancer Center Hospital, Department of Gastroenterological Surgery
Outcome results
None listed