A phase II study of S-1 therapy for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (OGSG1404)
- Conditions
- Esophageal carcinoma
- Registration Number
- JPRN-UMIN000016830
- Lead Sponsor
- Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
- Brief Summary
The disease control rate(DCR) was 46.7%. The response rate was 13.3%. The median progression-free survival was 2.0 months. The median time to treatment failure was 1.9 months. The median overall survival was 8.4 months, and the 1-year overall survival rate was 30.5%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 17
Not provided
1) with active double cancers excluding carcinoma in situ and/or prior cancer cured with shorter than 5 year interval period 2) with uncontrollable DM 3) with a history of cardiac infarction and/or anxiety angina pectoris within 6 months 4) with uncontrolled arrhythmia 5) under continuous steroids medication 6) with liver cirrhosis 7) with active infectious disease 8) with pericardial fluid, pleural fluid and/or ascites which needs drainage except controlled pleural fluid or ascites 9) have a history of Grade 2-4 hypersensitivity (CTCAE ver.4.0) 10) with grade 2-4 peripheral neuropathy by CTCAE v4.0 11) with blood transfusion within 2 weeks and/or continuous bleeding 12) with a figure of interstitial pneumonitis except radiation pneumonitis 13) with metastatic lesions in the central nerve 14) patient with psychological disorder who cannot participate in this study 15) women pregnant and/or nursing or men who like to have children in future 16) Any patients judged by the investigator to be unfit to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease control rate (DCR)
- Secondary Outcome Measures
Name Time Method Overall survival Progression free surviva(PFS) Time to Treatment Failure(TTF) Response rate(RR) Incidence of adverse events