gastric cancer
Conditions
Interventions
TS-1 fixed dose L-OHP fixed dose CPT-11 dose escalation
Sponsors
Osaka Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: "(1) Histological proven adenocarcinoma (2) unresectable gastric cancer (3) HER2 untested or negative (4) PS 0-1 (5) No history of chemotherapy or radiotherapy for unresectable gastric cancer (6) No massive ascites or massive pleural effusion retention (7) Patients without brain metastasis (8) Adequate organ function (9) Possible oral intake (10) Expected life span is more than 3 months (11) Written informed consent from patients "
Exclusion criteria
Exclusion criteria: "(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 "
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD, RD | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Incidence and extent of adverse events, Time to treatment failure, Progressin free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactTetsuji Terasawa
Osaka Medical College Hospital Chemotherapy Center
Outcome results
None listed