Phase II study of neoadjuvant and adjuvant docetaxel/cisplatin/5-fluorouracil in resectable esophagus cancer
- Conditions
- esophagus cancer
- Registration Number
- JPRN-UMIN000005588
- Lead Sponsor
- Jikei university of medicine department of surgery, department of oncology and hematology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
(1) Known hypersensitivity to taxanes, platinum, fluoropyrimidines. Known dihydropyrimidine-dehydrogenase (DPD) deficit. (2) Pre-existing motor or sensory neurotoxicity of a severity => Grade2 (CTCAE v4.0) (3) Active infectious diseases. (4) Symptomatic bleeding tendency, coagulation disorder, or coagulation factor deficiency. (5) Uncontrollable hypertension, uncontrollable diabetes, unstable angina, or heart failure. (6) Pre-existing renal insufficiency or proteinuria => 2+. (7) Clinical or radiographic signs of interstitial pneumonia or pulmonary fibrosis. (8) Active gastrointestinal bleeding, bowel obstruction. (9) Severe mental disorders, neurological disease (10) Pregnant or lactation women, or women with the possibility of the pregnancy. (11) Men who want let to pregnancy. (12) Patients who are judged inappropriate for the entry into this study by the investigator. (13) Active synchronous or metachronous malignancy, excepting for early stage cancers of the oral cavity, pharynx, larynx and early (stage Ia) gastric cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method