StageII,III,IV non-resective esophageal cancer and recurrece ofesophageal cancer
Conditions
Interventions
2010/12-2012/12 nedaplatin 70mg/m2 day1 Doc 60mg/m2 day1 5FU 700mg/m2/day day1-5
Sponsors
Gunma University Graduate School Department of General Surgical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.It is diagnosed as an esophageal carcinoma for histopathology or cytology. 2.It is advanced unresectable esophageal cancer (StageII, III or IV) or esophageal carcinoma recurrent. 3.the interval between last treatment(radiation, chemotherapy) and this study is 4 weeks or more. 4.There is evaluable lesion for treatment. 5.ECOG Performance status is 0-2. 6.We satisfy all the following conditions. that examination of an equal day two weeks of registration day ago permits it (1)4,000 white blood corpuscle >= /mm3 and 12,000 <= /mm3 (2)2,000 mature granulocyte >= /mm3 (3)100,000 blood platelet >= /mm3 (4)Haemoglobin >= 9.5g/dL (5)1.5 fold upper limit in the hospital AST <= IU/L (6)1.5 fold upper limit in the hospital ALT <= IU/L (7)Bilirubin total <= 1.5mg/dL (8)1.5 fold upper limit in the hospital Al-P <= IU/L (9)Creatinine <= 1.2mg/dL (10)PaO2 >= 60 torr (room air) 7.expected prognosis is 3 months or more. 8.About final examination participation, an agreement by a document from the person himself is obtained.
Exclusion criteria
Exclusion criteria: 1.It is the patient having an anaphylactic history for DOC, CDGP, 5-FU and polysorbate "80" component pharmaceutical. 2.Severe complicate disease (malignant hypertension, severe heart failure, liver failure, liver cirrhosis, diabetes mellitus under inadequate control, bleeding disorders) 3.Infectious disease with fever up 4.Regardless of presence of a cause, it is motor paralysis, the patient having peripheral neuropathy, severe edema 5.pleural effusion or cardiac effusion need to treatment. 6.The patient having active multiple primary cancer. 7.During the pregnancy or a pregnant female patient we are possible or are nursing. 8.The patient having the interstitial pneumonia that is apparent by chest X-rays or CT or pulmonary fibrosis 9.The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination. 10.the case that resarch contact doctor regards as inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival time, safety, efficacy, progression free survival time | — |
Countries
Japan
Contacts
Public ContactTatsuya Miyazaki
Gunma University Graduate School Department of General Surgical Science
Outcome results
None listed