Phase II study of Trastuzuman in combination with TS-1 and Cisplatin for patients with Human Epidermal Growth Facter Receptor type-2 (HER-2)-positive Advanced Gastric Cancer
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000008389
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 55
Not provided
1) Patients who received radiotherapy within 2 weeks before enrollment. 2) Patients with uncontrollable ascites, pleural effusion or pericardial effusion. 3) Patients with symptomatic brain metastases or carcinomatous meningitis. 4) Patients with other active malignancies. 5) Patients with active infections. 6) Patients with serious complications. 7) Patients with interstitial pneumonia or pulmonary fibrosis detected by chest X-ray. 8) Patients with a history of serious drug allergy. 9) Patients who receive continuous corticosteroid administration. 10) Patients who need to receive flucytosine. 11) Patients who need to receive continuous phenytoin or warfarin administration. 12) Patients with serious mental problem. 13) Pregnant or lactating female. 14) HBs antigen positive patients 15) Other patients evaluated to be inadequate to participate in this study by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival, Disease control rate, Overall survival, Time to Treatment Failure, Safety, Translational Research