Esophageal carcinoma
Conditions
Interventions
S-1: twice a day oral intake on days 1-28, followed by14 days rest.
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically proven esophageal squamous cell carcinoma or esophageal adenosquamous carcinoma 2) advanced/recurrent esophageal cancer resistant /intolerable to fluoropyrimydine (exclude S-1), platinum compounds, or Taxane 3) without prior use of TS-1 4) with/withnot measurable lesions by RESIST ver. 1.1 5) 20 years of age or older 6) Performance Status by Eastern Cooperative Oncology Group of 0 or 1 7) with an expected survival period longer than 3 months from the registration 8) with a rest longer than 14 days from the end of prior therapy 9) with good functions of important organs tested within 14 days before registration 1. Neutrophil: =>1,500/mm3 2. Hemoglobin: =>8.0 g/dl 3. Platelet: =>100,000/mm3 4. T.bil.: =<1.5 mg/dL 5. AST, ALT: =< 100 IU/L 6. cleatinine clearance : =>50mL/min 10) with HBs antigen negative within 1 year, or under administration of anti-nuclear analogues by a specialist for liver diseases when HSs is positive 11) with written Informed Consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Progression free surviva(PFS) Time to Treatment Failure(TTF) Response rate(RR) Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactTakayuki Ki
Osaka Medical College chemotherapy center
Outcome results
None listed