A Phase II study of combination chemotherapy with TS-1 and Trastuzumab for patients with HER2 positive advanced or recurrent gastric cancer.
- Conditions
- advanced or recurrent gastric cancer
- Registration Number
- JPRN-UMIN000008220
- Lead Sponsor
- Osaka medical center for cancer and cardiovascular diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1) Prior chemotherapy of TS-1 2) With severe allergy to TS-1 and Trastuzumab 3) Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant. 4) Active infection and inflammation. 5) History of cardiac disease 6) Patients with Severe complications 7) Patients with resting dyspnea 8) Patients with gastrointestinal ulceration and bleed 9) Patients with diarrhea (4 or more times per day or watery diarrhea). 10) Massive pleural or abdominal effusion 11) Patients with metastasis to CNS 12) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 13) Patients under treatment with flucytosine, phenytoin or warfarin potassium 14) Patients who are received systemic administration of corticosteroid. 15) Other patients who are unfit for the study as determined by the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method treatment completion ratio
- Secondary Outcome Measures
Name Time Method respons rete, progression-free survival, overall survival, time to treatment failure, Safety