Phase I/II trial of weekly docetaxel and concomitant radiotherapy for unresectable esophageal squamous cell carcinoma after induction chemothrapy
- Conditions
- nresectable esophageal squamous cell carcinoma after induction chemotherapy
- Registration Number
- JPRN-UMIN000004856
- Lead Sponsor
- Gastroenterologic surgery, Kanazawa university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
1) The presence of esophageal fistula 2) The presence of severe combined diseases including hear failure, renal failure, hepatic failure and uncontrollable diabetes mellitus. 3) Active infectious diseases (exept HBV or HCV infection). 4) Previous radiotherapy to chest. 5) Apparent interstitial pneumonia or lung fibrosis. 6) Combined active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment. 7) The presence of motor paralysis, peripheral neuropathy or edema. 8) No usage of contraceptive method for patients with reproductive age. 9) The presence of mental disease or disorder with difficulty in participating in the clinical trial. 10) Inadequate for clinical trial entry by the attending physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: To determine the maximaum tolerated dose (MTD) and recommended dose (RD) of Docetaxel Phase II: 2 year survival rate
- Secondary Outcome Measures
Name Time Method Phase I: response rate Phase II: complete remission rate, progression free survival, the rate of occurrence of adverse event, the rate of occurrence of late adverse event