Esophageal cancer
Conditions
Interventions
Combination chemotherapy consists of docetaxel (35 mg/m2/day, day 1 and day 15), nedaplatin (90 mg/m2/day, day 1), and 5-FU (800mg/m2/day, days 1 through 5). The treatment is repeated every 4 weeks un
Sponsors
Kinki university Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Primary tumor located at cervical esophagus, thoracic esophagus or esophago-gastric junction. 2)Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma or basaloid carcinoma. 3)Unresectable or recurrent esophageal cancer with no indication for surgery, radiotherapy, and chemoradiotherapy. a)In case of unresectable esophageal cancer, all of the following conditions must be fulfilled: i)Having metastatic lesion except for #102 or #104 metastases ii)cT1-cT4a iii)Dysphagia score =<2 and no stenosis which endoscope does not pass through b)In case of recurrent esophageal cancer, all of the following conditions must be fulfilled: i)Having metastatic lesion except for #102 or #104 metastases. ii)Dysphagia score =<2. 4)Older than 20 years old. 5)ECOG PS of 0,1 or 2. 6)Measurable lesion is required. 7)Neither previous chemotherapy ,chemoradiotherapy,nor radiotherapy against any cancer 8)Adequate organ function 9)Without symptomatic brain metastasis 10)Without moderate or more ascites/pleural effusion 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Poorly controlled diabetes mellitus or routine administration of insulin. 2)Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 3)History of hypersensitivity to 5FU, DOC, CDGP, or polysorbate 80. 4)Active infection requiring systemic therapy. 5)Patients requiring systemic steroid medication. 6)Motor paralysis or peripheral neuropathy by any reason. 7)Edema by any reason. 8)Severe pulmonary fibrosis or emphysema. 9)A case with the past of radiotherapy or the chemotherapy within two weeks before registration. 10)With moderate or more ascites/pleural effusion or pericardial fluid. 11) Severe cardiac disease , or with a history of myocardial infarction within 6 months , or poorly controlled hypertension. 12)A case to have the past of the cerebrovascular disorder that developed within six months. 13)A case to have diarrhea continuously. 14)Case having the intestinal tract paralysis, ileus 15)Positive HBs antigen , or positive HIV antibody. 16)The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination. 17) During the pregnancy or a pregnant female patient we are possible or are nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival overall survival adverse event | — |
Countries
Japan
Contacts
Public ContactHIROTO UEDA
Kinki University Faculty of Medicine Department of Medical Oncology
Outcome results
None listed