esophageal neoplasm
Conditions
Interventions
initial cohort n=30 aged 70 or younger docetaxel 70 mg/m2/day day1 iv cisplatin 70 mg/m2/day day1 iv 5-fluorouracil 750 mg/m2/day day1-5 civ q3w , 3 cycle Esophagectomy with D2 (or more) lymph
Sponsors
Saitama Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus 2) Primary lesion are located within the thoracic esophagus (Te) 3) Clinical stage II or III without T4 4) Aged 20 to 75 years old (expanding cohort ; aged 75 or younger) 5) ECOG PS of 0 or 1 6) no need for measurable lesion 7) no previous treatment of esophageal cancer 8) no previous chemotherapy or radiotherapy against any other malignancies 9) no palsy of recurrent nerve 10) adequate organ functions 11) curative resection for esophageal carcinoma 12) written informed consent
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential 3) Psychosis 4) Patients requiring systemic steroids medication 5) HBs antigen positive 6) Uncontrollable diabetes millutus 7) History of myocardial infarction or unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema 8) Active bacterial or fungous infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of treatment completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Progression free survival Resectability rate Adverse event Response rate | — |
Countries
Japan
Contacts
Public ContactHiroki Hara, MD
Saitama Cancer Center Department of Gastroenterology
Outcome results
None listed