Combination chemotherapy of TS-1, oxaliplatin and irinotecan (TIROX) for unresectable gastric cancer; a phase I study
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000030482
- Lead Sponsor
- Osaka Medical College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
"(1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. (2) Recurrence after surgery (3) Past history of severe hypersensitivity to drugs (4) Diarrhea (4 or more times per day or watery diarrhea) (5) Body temperature of over 38 degrees Celsius or active infection (6) serious bone marrow suppression, a renal damage or a liver damage (7) Severe complications (8) Positive HBs antigen (9) Under treatment with flucytosine or atazanavir (10) Under treatment with phenytoin or warfarin (11) Continuous systemic steroid therapy (12) Pregnant women, women with the possibility of the pregnancy, or men who want their partners to become pregnant (13) Psychological disorder (14) Patients judged inappropriate for the study by the physicians "
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MTD, RD
- Secondary Outcome Measures
Name Time Method Response rate, Incidence and extent of adverse events, Time to treatment failure, Progressin free survival, Overall survival