Gastric cancer
Conditions
Interventions
Preoperative chemotherapy with S-1 (80-120 mg/body, p.o., day 1-14) plus oxaliplatin (130 mg/m2, IV, day 1,) for 2cycles followed by gastrectomy with D2 lymph node dissection and postoperative chemoth
Sponsors
Tokyo Women's Medical University Department of surgery, Institute of Gastroenterology
Tokyo Women'
s Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients in Tokyo Women's Medical University Hospital. 2.Histologically proven gastric adenocarcinoma 3. Clinical T4a,4b(SE,SI) by imaging gastric cancer or enlarged lymph nodeby computed tomography. 4.No distatnt metastasis based on thoracic,abdominal,pelvic CT and staging laparoscopy is performed before registration, non-curable factors other than positive lavage cytology are not revealed. 5. No esophageal invasion or an invasion of 3 cm or less. 6. Age between 20 and 80 years old 7. Eastern Cooperative Oncology Group performance status of 0 or 1. 8. No bleeding from primary lesions nor obstruction. 9. Possible oral intake 10. Adequate organ function 11. Written informed consent from patient
Exclusion criteria
Exclusion criteria: 1) Past history of severe hypersensitivity to drugs 2) Severe complications 3) The patients with 4) Infectious disease requiring systemic treatment. 5) Poorly controlled hypertention. 6) Poorly controlled diabetes. 7) History of unstable angina pectoris or myocardial infarction within 12 months before registration. 8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 9) Uncontrolled psychiatry disease. 10) Peripheral sensory neuropathy of grade >= 2 . 11) Synchronous or metachronous (within 5 years) malignancies 12) Under treatment with flucytosine, phenytoin, or warfarin. 13) The patients who are pregnant women, or women with the possibility of the pregnancy. 14) Severe mental disease. 15) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 16) Massive pleural effusion or ascites 17) Active gastrointestinal tract bleeding requiring repeated transfusions. 18) Positive HIV antigen or positive HBs antigen 19) Patients judged inappropriate for the study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of R0 resection, | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year relapse-free survival, 3-year overall survival, 5-year relapse-free survival, 5-year overall survival, Response Rate, Pathological response rate, Percent completion of neoadjuvant chemotherapy, Incidence of adverse events on neoadjuvant chemotherapy, Incidence of a postoperative complication, proportion of protocol achievement | — |
Countries
Japan
Contacts
Public ContactKiyoaki Taniguchi
Tokyo Women's Medical University Department of surgery, Institute of Gastroenterology
Outcome results
None listed