esophageal cancer
Conditions
Interventions
docetaxel(70mg/m2/day) day1 cisplatin(70mg/m2/day1) day1 5-fluorouracil(700mg/m2/day) day1-5 q4w, 2 cycle
Sponsors
Shimane University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1,5)Patients with esophageal SCC who underwent currative (R0) resection without preoperative treatment and had pathological LN metastases 2)TNM stage 2 and 3 3)Age of 20 to 74 years with either gender and ECOG Performance Status of 0 to 2 4)No past history of chemotherapy, irradiation and operation for esophageal cancer 6)Laboratory values as follows 4000/mm3 < WBC < 12000mm3 2000/mm3 < Nuetrophil 100000/mm3 < Platelet count 9.0g/dL Hemoglobin AST,ALT < 2.0 times of normal upper limits Serum creatinine < 1.2mg/dL 60ml/min < Cleatinine clearance 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Past history of drug allergy 2)Past history of drug allergy of docetaxel, cisplati and fluorouracil 3)Patient with clinically obvious infecton 4)Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 5)Disease that is serious or requires hospitalization, or history of such disease within past year 6)Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage 7)Massive pleural effusion, ascites and pericardial effusion 8)Gastrointestinal hemorrhage 9)Chronic diarrhea (watery stool or 4 times or more/day) 10)Active hepatitis type HBs positive 11)More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment. 12)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of 2 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event Adverse eventProgression free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactNoriyuki Hirahara, M.D., Ph.D.
Shimane University Hospital Digestive and General Surgery
Outcome results
None listed