Gastric cancer Esophagogastric junction cancer
Conditions
Interventions
Oxaliplatin 130 mg/m2, IV day 1 , S-1 80-120 mg/m2/day, PO days 1-14, every 21 days for 3 cycles followed by surgery.
Sponsors
Kyushu Study group of Clinical Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The individual consents in writing to receipt of the protocol treatment 2) A lead investigator deems that the patient can be treated with the protocol (the patient is suitable for enrollment) 3) A common type of gastric adenocarcinoma (include Siewert Type III): T 3/4a/4b, N 1/2/3a/3b, esophagogastric junction adenocarcinoma classified as Siewert Type II: T 3/4a/4b, N 0/1/2/3a/3b 4) Enhanced thoracic/ abdominal/ pelvic CT revealed having none of the followings: i) Lung metastasis ii) Peritoneal metastasis iii) Liver metastasis iv) Pleural effusion, ascites v) Distal lymph nodes metastasis vi) Other distant metastasis 5) Clinically no sign of cervical lymph node nor distant metastasis 6) No liver metastasis and peritoneal metastasis, CY0 by laparoscopy 7) Not a remnant gastric cancer 8) No prior treatment of chemotherapy or radiation therapy or endocrine therapy against any other malignancies 9) No prior surgery for esophagogastric junction cancer and gastric cancer except for endoscopic resection 10) Age upon enrollment is over 20 years 11) Performance Status (ECOG) 0 or 1 12) The patient is readily able to take medication orally 13) The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient's laboratory results from up to 14 days prior to enrollment fall within the criteria i) WBC <=12,000/mm3 ii) Neutrophil >=1,500/mm3 iii) Platelet >=100,000/mm3 iv) Hemoglobin >=8.0g/dL v) Total bilirubin <=1.5mg/dL vi) AST,ALT <=100IU/L vii) Albumin >=2.5g/dL viii) Serum creatinine <=1.5mg/dL ix) Creatinine clearance >=60mL/min
Exclusion criteria
Exclusion criteria: 1) Severe drug hypersensitivity (particularly to platinum analogs, 5-FU, or S-1) 2) Peripheral neuropathy affecting the sensory nerves (Grade 1 or worse) 3) Active infection 4) Uncontrollable hypertension 5) Uncontrollable diabetes mellitus or routine administration of insulin 6) Heart disease that may pose a problem 7) Severe pulmonary disease 8) Severe mental disease 9) Active gastrointestinal tract bleeding requiring repeated transfusions 10) Under treatment with phenytoin, warfarin or flucytosine 11) Watery diarrhea (Grade 2 or worse) 12) Synchronous or metachronous malignancies other than carcinoma in situ or mucosal cancer 13) A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner 14) Cirrhosis or hepatitis 15) Patients judged by the investigator as unfit to be enrolled in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Anastomotic leakage of tumours are classified as Siewert Type II and Type III Overall survival Complete resection rate, resection rate Relapse free survival Response rate Adverse events Surgical complecations | — |
Countries
Japan
Contacts
Public ContactKSCC Research Secretariat
Clinical Research Support Center Kyushu KSCC Research Secretariat
Outcome results
None listed