Patients to be registered Esophageal cancer with distant metastasis (Stage IVb or stage IVa with N4)
Conditions
Sponsors
OGSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) with measurable lesion 2) esophageal cancer (Squamous cell carcinoma) diagnosed histologically or cytologically 3) without any prior therapy (surgery , chemotherapy or radiation therapy) 4) with distant metastasis 5) age: more than 20 years old and less than 75 ys. Old 6) Performance Status: 0 &#8211; 2 7) without any disorder in the important organs 1. WBC: 4,000 <= and <= 12,000/mm3 2. Neutrocyte >= 2,000 /mm3 3. Platelet: >= 10,000 /mm3 4. Hemoglobin: >= 9.0 g/dl 5. Total Bilirubin: <= 1.5 mg/dl 6. GOT, GPT: less than 2.5 times of normal range of each institute 7. serum Creatinin: <= 1.2 mg/dl Or Creatinin Clearance: more than 60 ml/min *Crockcroft-Gault method can be used instead of CC 8. PaO2: >= 70 torr (room air) 8) longer than 3 months of expected survival 9) with written informed consent
Exclusion criteria
Exclusion criteria: 1) severe disorders in The other organs(cardiac disorder, pulmonary fibrosis or interstitial pneumonia, Liver dysfunction) 2) brain metastasis with symptoms 3) edema which needs treatment 4) severe infectious disease 5) with high fever upper than 38 0C 6) with active double cancer 7) women under pregnancy and/or nursing or women who expects pregnancy 8) with a history of severe allergic reaction against medicines 9) uncontrolled cavity fluid in the chest, abdomen or heart 10) doctor's decision not to register to this regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| feasibility, survival period, survival time before progression (Time To Progression: TTP) | — |
Countries
Japan
Contacts
Public ContactShigeyuki Tamura/Hirohumi Miki
Kansai Rosai Hospital Dpt. surgery
Outcome results
None listed