A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000027506
- Lead Sponsor
- Cancer Institute Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
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 oxaliplatin or S-1 9) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason 10) Edema of limbs or 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year overall survival
- Secondary Outcome Measures
Name Time Method Proportion of R0 resection, 5-year overall survival, 3- and 5-year recurrence free survival, Proportion of completion of surgery, Proportion of completion of protocol treatment, Clinical response rate, Pathological response rate, Adverse events from chemotherapy, Operation time, Intraoperative blood loss, Surgical complications, Postoperative hospital stay