esophageal cancer
Conditions
Interventions
pegfilgrastim:3.6mg(s.c.) on day3 in the first course of DCF regimen.
Sponsors
Kyoto Prefectural University of Medicine, Gatroenterology and Hepatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma. 2) Diagnosed clinical stage II, III,IV based on the UICC-TNM classification with PET-CT or contrast-enhanced CT, and able to receive DCF regimen. 3)Aged over 20 years old. Male and Female. 4)No prior chemotherapy or radiotherapy against malignancy. 5)ECOG performance status of 0 or 1 6)Able to receive full-dose DCF regimen from fist course as preoperative or induction chemotherapy before CRT. 7)Cases with adequately maintained organ functions and fullfilling the following conditions within 14 days before registration. leukocyte count >= 4000 and < 12000/uL neutrophil count >= 1,500/ mm3 hemoglobin level >= 10.0g/ dL platelet count >= 100,000/mm3 AST and ALT <= 100IU/L total bilirbin <= 1.5mg/dL serum creatinine <= 1.5mg/dL Creatinine clearance >= 60ml/min 8)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Synchronous or metachronous malignancies other than carcinoma in situ or mucosal carcinoma 2)Evidence of any other serious disease 3)Active local or systemic infection under treatment 4)History of serious allergic reaction 5)Pulmonary fibrosis or interstitial pneumonitis detected by chest X-ray 6)primary hematologic disease 7)Serious allergic reaction to Docetaxel, cisplatin, 5FU and pegfilgrastim 8)Massive pericardial effusion, pleural effusion or ascites 9)Received radiotherapy within 4 weeks before 10)Received drugs of other clinical tests within 4 weeks before 11)History of receiving pegfilgrastim before 12)Pregnant or lactating female 13)Judged inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of less than 500/uL of neutrophillic number confirmed after 1st course. | — |
Countries
Japan
Contacts
Public ContactTakeshi Ishikawa
Kyoto Prefectural University of Medicine Department of Gatroenterology and Hepatology
Outcome results
None listed