A randomized controlled phase III study comparing docetaxel, cisplatin and 5-FU (2-weekly DCF) with cisplatin and 5-FU (CF) in patients with metastatic or recurrent esophageal cancer (JCOG1314, MIRACLE study)
- Conditions
- esophageal cancer
- Registration Number
- JPRN-UMIN000015107
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
Not provided
1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Active infection requiring systemic therapy. 3) Pregnancy, possible pregnancy or breastfeeding. 4) Psychiatric disease. 5) Patients requiring systemic steroid medication. 6) Under treatment with flucytosine, phenytoin, or warfarin. 7) History of iodine allergy. 8) History of hypersensitivity to DOC, CDDP, or polysorbate 80. 9) Poorly controlled diabetes mellitus. 10) Severe pulmonary fibrosis or emphysema. 11) Poorly controlled hypertension. 12) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months. 13) Positive HBs antigen, or positive HIV antibody
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method