esophageal cancer
Conditions
Interventions
S-1 80mg/ m2/day (day1-14, 29-42, po) NDP 80mg/m2/day (day1, 29, iv) Radiation therapy 1.8Gy/day, 28fractions (day1-38), 5 fractions/week, total 50.4Gy
S-1 80mg/ m2/day (day1-14, 29-42, po) N
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Pathologically proven squamous cell carcinoma or adenocarcinoma of the esophagus b) tumors can be included within a single irradiation field c) age >= 20, <= 75 d) Karnofsky performance status : >= 70% e) Patients with sufficient organ function -WBC >= 3,000 /mm3 -Platelet >= 100,000 /mm3 -Hb >= 10 g/dL -GOT, GTP <= 2.0 times upper limit of normal(ULN) -T.Bil <= 1.5 mg/dL -Creatinine <= 1.2 mg/dL -Creatinine clearance or eGFR <= 50 ml/min -PaO2 >= 70 mmHg -ECG: no severe abnormalities f) No prior chemotherapy or no prior irradiation g) Written informed concent
Exclusion criteria
Exclusion criteria: a) with active gastrointestinal hemorrhage b) with clinically important infection c) with severe complicatons (heart failure, renal failure, liver failure, uncontrollable diabetes, etc.) d) with another active malignant tumors e) pregnant and/or lactating women f) judged not to understand the trial explanation g) judged to be unfit to participate in this study by investigater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year local control rate within PTV. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression-free survival, frequency and degree of adverse events, and Quality of life in full observation period. | — |
Countries
Japan
Contacts
Public ContactKIRITOSHI Tomoki
The University of Tokyo Hospital The department of Radiology
Outcome results
None listed