Phase I/II trial of preoperative TS-1 + CDDP + radiation therapy for large type 3 or type 4 advanced gastric cancer (OGSG 1205)
- Conditions
- Resectable large type 3 or type 4 Gastric Cancer
- Registration Number
- JPRN-UMIN000008964
- Lead Sponsor
- Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I : Feasibility of the regimen followed by decision of recommend dose Phase II : histological response rate of grade 3
- Secondary Outcome Measures
Name Time Method 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