Gastric Cancer
Conditions
Interventions
preoperative CapeOx therapy Capecitabine : 1,000mg/m2 bid, day1-14, q3w Oxaliplatin : 130mg/m2, day 1, q3w 3 cycle Surgery Postoperative CapeOx therapy Capecitabine : 1,000mg/m2 bid, day1-14, q3
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven gastric carcinoma by endoscopic detection 2)HER2 negative or unknown 3)With any lesion written below by upper abdominal enhanced CT: 1.Paraaortic node metastases (#16a2/16b1) larger than 10mm 2.Bulky lymph node metastases located at celiac axis, common hepatic artery, splenic artery and/or upper mesenteric vein which make a huge bulk larger than 3.0 cm and/or multiple large bulks larger than 1.5 cm 3.Paraaortic and bulky metastatic nodes 4)Without any lesions written below by thoratic, upper abdominal and pelvic enhanced CT: 1.mediastinal node metastases 2.lung metastases 3.peritoneal metastases 4.liver metastases 5.pleural fluid and/or ascites 6.paraaortic nodes metastases (# 16a1 and/or #16b2) 7.Other distant nodes metastases and/or CY1 5) Not a large type 3 or type 4 gastric cancer Large: the size of cancer is larger than 8 cm 6)Without esophageal invasion longer than 3 cm 7)Not a remnant gastric cancer 8)Without cervical nodes metastases and/or distant metastases 9)Age between 20 and 75 years old 10)An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 10)An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 11) Without any prior chemotherapy, radiation therapy and/or hormone therapy for the gastric cancer and/or any other cancers 12)Without prior surgical therapy except EMR/ESD and/or bypass 13) Patients can take food orally with /without bypass 14) With good functions of important organs by a data taken within 2 weeks of registration 1.Neutrophil: =>1,500/mm3 2.Hemoglobin: =>8.0 g/dL without blood transfusion 3.Platelet: =>100,000/mm3 4.AST, ALT: =< 100 IU/L 5.T.bil.: =<2.0 mg/dL 6.Creatinine clearance: =>60 ml/min/body CC by Cockcroft-Gault method is available:=>60mL/min 15) With written Informed Consent
Exclusion criteria
Exclusion criteria: 1)With active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period 2)Pregnant or nursing female 3)Male expecting pregnancy of partner 4)Impossible to register to the study due to a psychological disorder by physician in charge's decision 5)Under continuous steroids medication 6)Patients who receives systemic continuous administration of phenytoin or warfarin potassium 7)With neuropathy on peripheral motor and/or sensory nerves: -> glade 2 of CTCAE v4.0 8)With interstitial pneumonitis, pulmonary fibrosis and/or severe pulmonary emphysema 9)With active bacterial/fungal infectious disease (with a fever over 38 centigrade) 10)With a history of cardiac infarction and/or anxiety angina pectoris within 6 months 11)With uncontrollable blood hypertension 12)With uncontrollable DM 13)With uncontrollable Diarrhea 14)Positive HBs antigen 15)Severe complications 16)Any other patients whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate(RR)(RECISTv1.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Overall survival(OS) 2.Progression free survival 3.Rate of curative resection 4.Complete rate of protocol 5.Complete rate of preoperative chemotherapy 6.Complete rate of operation 7.Complete rate of postoperative chemotherapy 8.Relative Dose Intensity (RDI) 9.Response Rate of Histologically 10.Incidence of adverse events on perioperative chemotherapy 11.Incidence of a intraoperative and postoperative complication 12.Response Rate (RR)(RECISTv1.1) | — |
Countries
Japan
Contacts
Public ContactNaotoshi Sugimoto
Osaka International Cancer Institute Department of medical oncology
Outcome results
None listed