Esophageal cancer Esophageal cancer
Conditions
Interventions
Concurrent chemoradiotherapy with paclitaxel, cisplatin and 5-FU
Sponsors
Yamamoto Sachiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma, or adenosquamous cell carcinoma or basaloid of the esophagus 2) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae) 3) Aged 20 to 75 years old 4) ECOG PS of 0 or 1 5) Clinical stage IA - IIIC 6) No need for measurable lesion 7) No previous treatment of esophageal cancer except endoscopic surgery 8) No palsy of recurrent nerve 9) No adaptation of surgery or refused esophagectomy 10) Adequate organ functions 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer or expected cure in surgery 2) history of radiotherapy for mediastinum 3) Uncontrollable diabetes mellitus 4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac function disorder 5) Uncontrollable arrhythmia 6) Patients requiring systemic steroids medication 7) Liver cirrhosis 8) Active bacterial or fungous infection 9) With a history of grade 2-4 allergic reaction by CTCAE version 4.0 10) With a history of grade 2-4 nerve disturbance by CTCAE version 4.0 11) With blood transfusion within 2weeks and/or active bleeding 12) Interstitial pneumonia, fibroid lung or severe emphysema 13) With a history of allergic reaction to platinum, polyoxy-ethilen oil, hydrogenated castor oil or polysorbate 80 14) Psychosis 15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future 16) Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT occurrence rate at each dose level | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, Adverse event | — |
Contacts
Public ContactSachiko Yamamoto
Osaka International Cancer Institute
Outcome results
None listed