Phase 1 study of Docetaxel and Oxaliplatin and TS-1 for unresectable / recurrent gastric cancer (KOGC-06)
- Conditions
- unresectable / recurrent gastric cancer
- Registration Number
- JPRN-UMIN000015723
- Lead Sponsor
- Keio University School of Medicine, Department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Not provided
(1) Patients with severe ischemic heart disease or arhythmia. (2) Patients with myocardial infarction within 6 months. (3) Patients with liver cirrhosis or active hepatitis. (4) Patients with dyspnea needing oxygen. (5) Patients with fresh gastrointestinal bleeding which require a repeat blood transfusion. (6) Patient who have been treated with antipsychotic drugs, or patient with mental disorder requiring medication. (7) Patients with uncontrolled diabetes mellitus. (8) Patients with ileus or subilues. (9) Patients with fever infection. (10) Patients who have history of active simultaneous or metachronous double cancers within 5 year. However, patient with carcinoma in situ or intramucosal carcinoma curable with local therapy is excluded for active double cancer. (11) Patients with CNS metastases. (12) Patients with acute infectious diseases. (13) Patients with peripheral neuropathy. (14) Patients with history of severe adverse event suspected to be caused by drugs. (15) Patients with history of severe adverse event suspected to be caused by Polyoxyethylene Castor Oil or hydroxyohlorinatedcasteroil. (16) Patients who are pregnant women, possibly pregnant women, willing to become pregnant, and nursing mothers. (17) Patients who are inappropriate for the study at the physician's assessment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of dose limiting toxicity
- Secondary Outcome Measures
Name Time Method Overall Response rate