Esophageal cancer Esophageal cancer
Conditions
Interventions
docetaxel and nedaplatin are administered intravenously on day1 every 2 weeks at a dose of 30mg/m2 (body surface area), until disease progression or unmanageable toxicity
Sponsors
Nagano Hiroaki
Takeda Shigeru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with unresectable or recurrent esophageal cancer who are not eligible for curative treatment (surgery, radiotherapy, chemoradiotherapy)and have been previously treated with 5FU +CDDP and PD-1 blocking antibody 1) For unresectable esophageal cancer, all of the following i)-iii) are met. i) Distant metastasis other than #102 mid (middle deep cervical lymph node)or #104 (supraclavicular lymph node). Even if the short diameter of the lymph node is less than 10 mm, it is considered a lymph node metastasis if it can be clearly judged as a tumor lesion by FDG-PET, ultrasonography, or clinical course. ii) Tumor depth is cT1-4a. iii) Dysphagia score =1,500/mm3 Hb:>=9.0 g/dl Plt:>=100,000/mm3 T-Bil:=50ml / min (Cockcroft- Gault) CCr should be greater than or equal to 50 mL/min/body as estimated by the Cockcroft-Gault equation. Even if the estimated value is less than 50 mL/min/body, the patient is eligible if the measured value is confirmed to be 50 mL/min/body or more. 11.No blood transfu
Exclusion criteria
Exclusion criteria: 1.Patients with a history of taxane use in the previous treatment history. (Preoperative or postoperative adjuvant therapy and radical chemoradiation can be enrolled if 180 days have passed since the last dose.) 2.Patients with Grade 2 or higher peripheral neuropathy at the time of obtaining written informed consent 3.Patients who have history of severe drug allergy. 4.Patients who have active infectious disease. 5.Patients with active multiple cancers (Active multiple cancers are defined as concurrent multiple cancers and heterogeneous multiple cancers with a disease-free interval of 5 years or less. However carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma that are considered curable by local treatment are not included in active multiple cancers). 6.Patients have symptomatic bone or brain metastases. 7.Patients who has severe complication Infectious disease on antibiotics. diabetes mellitus under treatment or poorly controlled by continuous insulin use poorly controlled hypertension myocardial infarction occurring within 6 months unstable angina pectoris liver cirrhosis Interstitial pneumonia or pulmonary fibrosis 8.Patients who want to be pregnant and /or pregnant woman 9.Patients with psychosis or psychiatric symptoms that make it difficult to participate in clinical research 10.Patients who was judged to be unsuitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression free survival, response rate, Disease control rate. | — |
Contacts
Public ContactShigeru Takeda
Yamaguchi University Hospital
Outcome results
None listed