Phase II study of a utility and the biomarker of the capecitabine plus cisplatin chemotherapy for the HER2-negative gastric cancer which is impossible of curative resectio
- Conditions
- Advanced gastric cancer
- Registration Number
- JPRN-UMIN000012491
- Lead Sponsor
- Department of Clinical Oncology, Toho University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Not provided
(1) Patient who had previously received chemotherapy including a fluorouracil based regimen at least 6 months before registration (2) Patient who had previously received chemotherapy including a Platinum based regimen (3) Patient with history of severe adverse event suspected to be caused by dihydropyrimidine dehydrogenase (DPD) deficiency (4) Active concomitant malignancy (History of active double cancer within 5 years prior to the study) (5) Patient who has severe or uncontrolled complication (infection, pulmonary fibrosis, paralytic intestine, bowel obstruction, uncontrolled diabetes mellitus, liver cirrhosis, uncontrolled hypertension, myocardiac infarction or unstable angina within 6 months before registration) (6) Patient who needs drainage of peritoneal, pleural or pericardial effusion (7) With symptoms due to brain metastasis (8) Active (significant or uncontrolled) bleeding from GI tract (9) Uncontrollable serious mental problem (10) Patient with recurrent gastric cancer have had history of severe diarrhea (>=Grade 3) in previous adjuvant chemotherapy (11) Patients with diarrhea (increase of 4 and more stool frequency per day over baseline or watery stool) at registration (12) Administrated antithrombotic drug or drug affected to congealing fibrinogenolysis system within 14 days before enrollment (Except for low dose of aspirin) (13) Women who is pregnancy, possible pregnancy or lactation and patients who wish their partner to become pregnant (14) Patients who have condition corresponding with contraindication for the administration of Capecitabine and Cisplatin. (15) Any other patients whom the physician in charge of the study judges to be unsuitable
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Overall survival Progression free survival Adverse event rate Exploring several predictable biomarkers