Gastric cancer Gastric cancer
Conditions
Interventions
Oxaliplatin 130 mg/m2, IV day 1 ,
S-1 80-120 mg/ day or 50-100 mg/m2/day, PO days 1-14, every 21 days for 3 cycles followed by curative surgery.
Sponsors
Saeki Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)The individual consents in writing to receipt of the protocol treatment. 2)The cancer is histologically confirmed (via biopsied tissue) to be an adenocarcinoma. 3)The tumor is diagnosed with cT3-4 by imaging findings. 4)Enhanced upper abdominal CT revealed having gastric regional lymph nodes swelling with greater than 8mm in minor axis diameter or 10mm in major axis diameter (N1-3). 5)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 6) Clinically no sign of cervical lymph node nor distant metastasis. 7) No liver metastasis and peritoneal metastasis, CY0 by laparoscopy. 8) Not a remnant gastric cancer. 9) The patient can have oral intake. 10) No prior chemotherapy or radiation therapy or endocrine therapy against any other malignancies within 5 years. 11) 70 years of age or older 12) Performance Status (ECOG) 0 or 1 13) The patient's laboratory results from up to 14 days prior to enrollment fall within the criteria i) Neutrophil >=1,500/mm3 ii) Hemoglobin >=8.0g/dL iii) Platelet >=100,000/mm3 iv) Total bilirubin =40mL/min
Exclusion criteria
Exclusion criteria: 1) 3cm or greater in distance of esophageal invasion 2) Type 4 gastric cancer macroscopically involving whole stomach 3) Severe drug hypersensitivity (particularly to platinum analogs, 5-FU, or S-1) 4) Peripheral neuropathy affecting the sensory nerves (Grade 1 or worse) 5) Active infection 6) Uncontrollable hypertension 7) Uncontrollable diabetes mellitus 8) Heart disease that may pose a problem 9) Severe pulmonary disease 10) Severe mental disease 11) Active gastrointestinal tract bleeding requiring repeated transfusions 12) Under treatment with phenytoin, warfarin or flucytosine 13) Watery diarrhea (Grade 2 or worse) 14) Synchronous or metachronous active malignancies 15) A man who is trying to conceive with a partner 16) Cirrhosis or active hepatitis 17) Patients judged by the investigator as unfit to be enrolled in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative dose intensity of preoperative SOX therapy Protocol treatment completion rate Completion rate of SOX 3 courses + curative surgery Completion rate of 3 courses of preoperative chemotherapy Response rate of preoperative chemotherapy Rate of occurrence of adverse events Rate of occurrence of surgical complications Pathological response rate R0 Resection rate Overall survival (OS) Relapse Free Survival (RFS) | — |
Contacts
Public ContactHiroshi Saeki
Graduate School of Medicine, Gunma University
Outcome results
None listed