Esophageal squamous cell carcinoma
Conditions
Interventions
Neoadjuvant chemotherapy by S-1 plus cisplatin
Sponsors
Nagoya University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed esophageal squamous cell carcinoma 2) Clinical stage III according to the Japanese classification of esophageal cancer (10th edition) 3) Age between 20 and 75 at registration 4) Performance Status(ECOG) 0 or 1 5) No prior treatment of chemotherapy or radiation therapy against any other malignancies 6) Adequate organ function 7) Written informed consent from patient
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ 2) Uncontrolled infection 3) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 4) Psychiatric disease 5) Continuous systemic steroid therapy 6) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.) 7) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated 8) Symptomatic CNS metastasis 9) Interstitial lung disease or pulmonary fibrosis 10) Hypersensitivity for S-1 or cisplatin 11) Flucytosine, phenytoin, warfarin potassium or aminoglycoside antibiotic administration 12) Intestinal bleeding 13) Judged by physician inadequate for inclusion in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event, 2 year survival rate, Progression free survival, Relative dose intensity, Pathological response | — |
Countries
Japan
Contacts
Public ContactMasahiko Koike
Nagoya University Graduate School of Medicine Department of Gastroenterological Surgery
Outcome results
None listed