Gastric cancer
Conditions
Interventions
It takes three weeks for a one course of Cisplatin plus capecitabin combination therapy Standard treatment is two courses before surgical operation Cisplatin (80 mg/m2) is administered on day 1 and
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. 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 a) WBC: =>4000/mm3 b) Neutrophil: =>1,500/mm3 c) Hemoglobin: =>8.0 g/dl without blood transfusion d) Platelet: =>100,000/mm3 e) AST, ALT: =< 100 IU/L f) T.bil.: =<1.5 mg/dL g) S-cleatinine: =<1.2mg/dL h) 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 flucytosine, phenytoin or warfarin 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)Any other patients whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) Curative operation rate Preoperative treatment completion rate Surgical operation completion rate Hole treatment schedule completion rate Histological response rate Safety check (AE, postoperative complication) | — |
Countries
Japan
Contacts
Public ContactHiroshi Furukawa
Kinki University School of Medicine Department of surgery
Outcome results
None listed