Esophageal cancer
Conditions
Interventions
None listed
Sponsors
Gifu University
ajinomoto pharmacotheuticus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary tumor is either neck, chest, abdomen esophagus. You have been diagnosed with either squamous cell carcinoma, adenocarcinoma squamous cell carcinoma, adenocarcinoma of histopathologically. It is esophageal cancer StageII registration and III, it can be a surgery by chemotherapy or adaptation of surgery. Age of the registration date is 75 years old 20 years of age or older. ECOG Performance Status is 0 or 1. There is no history of radiation therapy chemotherapy, chemical and radiation therapy for all cancer types, including esophageal cancer. Organ function is maintained. There is no brain metastases with symptoms. Is not allowed pleural effusion of moderate or more, the ascites. Can be taken of enteral nutrition and oral intake enough. For the study participants, written consent from the person is obtained.
Exclusion criteria
Exclusion criteria: It is complicated by diabetes treatment by the continued use of insulin. Or mucous membranes (carcinoma in situ) carcinoma in situ, which is determined to be treated by topical treatment but patients that with a double cancer of activity is not included in the double cancer of active lesions in cancer equivalent. DOC, CDDP ,5-FU, and patients with a history of hypersensitivity to polysorbate 80-containing formulation. Patients with contraindications to administration Elental. I have a history of hypersensitivity to Elental. I have disorders of amino acid metabolism I have a fungal infection and bacterial activity. patients receiving systemic administration's ongoing steroids. Regardless of the presence or absence of cause, motor paralysis, and has a peripheral neuropathy. Patients with or without cause, admit edema. Patients with pulmonary fibrosis or interstitial pneumonia evidenced by CT or chest X-ray. Patients is determined participation in the test is difficult and complicated by psychiatric symptoms or psychosis. Patients participating in the clinical trial of the other endpoint is a duplicate. Patients with a possibility of pregnancy or during pregnancy. Cases study director doctor has determined to be inappropriate as a target for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oral mucositis (over grade2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity except for oral mucositis, safety of Elental, response rate of chemotherapy, resection rate, completion rate of chemotherapy, weight, QOL survey (QLQ-C30) | — |
Countries
Japan
Contacts
Public ContactYoshihiro Tanaka
Gifu university surgical oncology
Outcome results
None listed