large type 3 or type 4 gastric cancer
Conditions
Interventions
It takes four weeks for one course of DCS therapy (DTX 40 mg/m2 iv day 1, CDDP 60 mg/m2 iv day 1 and TS-1 80-120 mg/body day 1-14, followed by 2 weeks rest) Standard treatment is two or three courses
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)Macroscopic finding is type 4 or type 3 whose size is over 8 cm by endoscopy and/or CT within 28 days before registration 3)Without any P2, P3, liver metastases and/or paraaortic node metastases by CT, PET and/or laparoscopic detection within 28 days before registration 4)Without esophageal invasion longer than 3 cm by endoscopic detection within 28 days before registration 5)Age older than 20 years and younger than 75 years 6)Performance Status(ECOG): 0 or 1 7)Without any history of chemotherapy, radiation therapy and/or surgical operation for the gastric cancer 8)with good functions of important organs by a data taken within 2 weeks of registration a) WBC: =>4000/mm3 and <12,000 mm3 b) Neutrophil: =>1,500/mm3 c) Hemoglobin: =>8.0 g/dl d) Platelet: =>100,000/mm3 e) AST: =< 100 IU/L f) ALT: =< 100 IU/L g) T.bil.: =<1.5 mg/dL h) s-cleatinine: =<1.2mg/dL i) creatinine clearance: =>60 ml/min/body CC by Cockcroft-Gault method is available: => 60mL/min 9)enough oral intake 10)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)with a history of severe allergic reaction against medicines 3)with active infectious diseases (over 38 centigrade of body temperature) 4)pregnant or nursing female 5)male expecting pregnancy of partner 6)with a history of cardiac infarction within 6 months 7)under continuous steroids medication 8)under continuous medication of phenytoin or warfarin 9)with uncontrollable diarrhea (frequent movement and/or watery stool) 10)with HBs antigen positive or HCV antibody positive 11)With severe diseases (collagen disease, intestinal paralysis, interstitial pneumonitis, and/or ischemic cardiac disease) 12)Any other patients whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of curative resection (R0 ratio) | — |
Secondary
| Measure | Time frame |
|---|---|
| Preoperative treatment completion rate Postoperative treatment completion rate Disease Free Survival Overall Survival (OS) Response Rate of preoperative chemotherapy (RECIST v 1.1) Histological Response Rate of preoperative Chemotherapy AE rate of preoperative chemotherapy Incidence of postoperative adverse events | — |
Countries
Japan
Contacts
Public ContactJyunji Kawada
Kaizuka City Hospital Department of Surgery
Outcome results
None listed