Resectable large type 3 or type 4 Gastric Cancer
Conditions
Interventions
Drug: TS-1, CDDP, and radiation [Level 0] TS-1: 60mg/m2 po between day 1 and day 14 CDDP: 60mg/m2 iv on day 1 Radiation:2Gyx5/week X 4 [Level 1] TS-1: 80mg/m2 po between day 1 and day 14 CDD
Sponsors
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed gastric adenocarcinoma 2)Type 3 or Type 4 gastric cancer 3)The size of type 3 cancer is larger than 8cm by CT 4)No peritoneal metastases and CY0 by diagnostic laparoscopy 5)Patient expected R0 resection at the registration 6)Esophageal invasion is smaller than 1cm and no duodenal invasion 7)Age between 20 and 75 years old 8)Performance status (ECOG scale) 0 or 1 9)Without any prior chemotherapy and/or surgical treatment 10)Without bleeding from stomach lesion or stenosis on bowel 11)Adequate baseline organ and marrow function from data within 14 days before registration a.WBC : >=4.000/mm3 and <12,000/mm3 b.Absolute neutrophil count : >=2,000 / mm3 c.Platelets : >=100,000 / mm3 d.Hemoglobin : >=9.0 g/dL e.AST (SGOT)/ALT (SGPT) : <100 IU/L f.Total bilirubin : <2.0mg/dL g.Creatine clearance : >=60mL/min *Cockcrft-Gault method is available 12)Patients who can take food orally 13)Patients should sign a written informed consent
Exclusion criteria
Exclusion criteria: 1)with active double cancer within 5 years except intramucosal cancer 2)with a history of severe allergy 3)with active infectious disease(over 38 degrees C) 4)Women in pregnancy, at risk of pregnancy, or hoping to become pregnant. 5)Men who want their partners to become pregnant 6)with a history of cardiac infarction in recent 6 months 7) with a continuous administration of steroids 8)patient who needs continuous administration of Flucytosine, fenitoin or walfarin karium 9)with ulceration on digestive tract and/or bleeding from the ulcer 10)with uncontrollable diarrhea or watery stool 11) with active hepatitis B Ag and/or hepatitis C Ab 12) with serious complication as followings, -Interstitial pneumonia -Pulmonary fibrosis -paralysis on bowel -ischemic heart diseases 13)Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I : Feasibility of the regimen followed by decision of recommend dose Phase II : histological response rate of grade 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I : histological response rate of grade 3 Phase II : Response Rate, RFS, OS, completion rate of surgical operation, completion rate of curative resection, completion rate of hole regimen, incidence of down staging, incidence of surgical complications and the grade, and incidence of adverse events and the grade | — |
Countries
Japan
Contacts
Public ContactMotohiro Imano
Kinki University School of Medicine Department of Surgery
Outcome results
None listed