PhaseII trial of capecitabine plus cisplatin in patients with recurrent HER-2 negative gastric cancer during or after the adjuvant chemotherapy using S-1 (T-CORE1102)
- Conditions
- HER2 negative gastric cancer
- Registration Number
- JPRN-UMIN000006804
- Lead Sponsor
- Tohoku Clinical Oncoogy, Research and Education Society(T-CORE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 21
Not provided
Exclusion criteria were as follows: 1) Cy1. 2) Patients who have been treated with platinum preaviously. 3) A history of drug sensitivity to fluoropyrimidine or platinum 4) Active double cancer within 5 years (except carcinoma in situ and skin cancer which were cured) 5) Active infection or inflammation (fever with 38.0 degree or higher) 6) Active hepatitis 7) Severe heart disease or that history within 1 year. 8) Patient with serious complications such as gastrointestinal paralysis, ileus, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetis mellitis, renal failure, liver damage, and liver cirrhosis. 9) Patient who needs treatments of phenytoin or warfarin. 10) Chronic diarrhea (diarrhea of more than 4 times daily, or watery diarrhea) 11) Active GI tract bleeding. 12) Patient who need drainage of peritoneal, pleural or pericardial effusion. 13) Clinically suspicious of brain metastasis, or that history. 14) Pregnancy, possible pregnancy or lactation. 15) Men who wish their partner to become pregnant 16) Treatment or that previous history of psychiatric diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median progression free survival (PFS)
- Secondary Outcome Measures
Name Time Method