unresectable and recurrent esophageal cancer
Conditions
Interventions
DCF-R Docetaxel (50mg/m2)day1,29, CDDP(60mg/m2) day1,29, 5-FU(600mg/m2)day1-4, 29-32 Radiation 2Gy30times
CF-R CDDP(70mg/m2) day1,29, 5-FU(700mg/m2)day1-4, 29-32 Radiation 2Gy30times
Sponsors
Gunma University Hospital Integrative center of general surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)The histologiy or cytology of the esophageal cancer (squamous cell carcinoma, adenocarcinoma) is confirmed. 2)The unresectable or recurrence cancer of the esophagus. 3)The age at registration is less than 75 years old 20 years old or older 4)PS(ECOG) is a case of 0 or 1. 5)A case (it is not said that the measurable lesion is required) that an evaluable lesion is confirmed with objective documents such as CT, MRI, X-ray within 30th before registration. 6)The case that did not undergo chemotherapy or radiotherapy in unresectable cancer of the esophagus. But we allow only for a case to be more than 180 days after last dosage day when adjuvant chemotherapy is enforced after surgery. 7)The case that the following main organ functions are secured for less than 14 days before registration by inspection of (possible as for the inspection of the same day two weeks before the registration day). 1)A white blood-cell count: It is less than 12,000 /mm3 more than 3,000 /mm3 2)A neutrophilic number: More than 1,500 /mm3 3)The number of the platelets: More than 100,000 /mm3 4)Hemoglobin: More than 9.0 g/dL 5)Total bilirubin: Lower than 2.0 mg/dL 6)AST (GOT): 100IU/L or less 7)ALT (GPT):) 100IU/L or less 8)Serum creatinine: Lower than 1.2 mg/dL 9)Creatinine clearance: It is more than 60 mL/min When I measure creatinine clearance by the urine collection for 24 hours, I use the value. When there is not an actual value, I calculate an estimate using a following Cockcroft-Gault estimates type. Creatinine clearance estimate =(the (140-age) X weight)/ [72* serum creatinine level] (do a value provided in the case of a woman more 0.85 times) 8)The case that survival more than three months is expected. 9)The case that a written agreement is provided from a patient.
Exclusion criteria
Exclusion criteria: 1)The patients with a history of severe drug hypersensitivity. 2)Pregnant women or women that might be pregnant. Men who wish to partner pregnancy. 3)patients with active infection (fever over 38 degree). 4)cases of serious complications (interstitial pneumonia or pulmonary fibrosis, kidney failure, liver failure, poor control of diabetes, control such as failure of the high blood pressure). 5)significant ECG abnormalities are observed cases or heart disease (heart failure to be a clinical problem, myocardial infarction, patients with angina pectoris). 6)the active gastrointestinal tract ulcers or patients with bleeding. 7)patients with sensory neuropathy. 8)Serious cases of diarrhea. 9)patients with ascites and pleural effusion requiring drainage by continuous drainage detention. 10)patients with brain metastases or case to suspect brain metastases from clinical symptoms 11)patient with cancer of less than five years disease-free period (healing skin basal cell cancer and cervical cancer or endoscopic mucosal resection by healing, it has been confirmed, esophageal cancer, colon pM cases of cancer I and registration available). 12)patients undergoing continuous systemic administration of steroids. cases 13)attending physician is considered unsuitable for participation in the study. 14)Docetaxel, case is the administration contraindication of CDDP, 5-FU.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival rate, progression free survival rate, response rate, disease control rate, toxicity | — |
Countries
Japan
Contacts
Public ContactMiyazaki Tatsuya
Gunma University Hospital Integrative center of general surgery
Outcome results
None listed