JPRN-UMIN000015107
Recruiting
Phase 3
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) - A randomized phase III study comparing 2-weekly docetaxel combined with cisplatin plus 5-FU (2-weekly DCF) with cisplatin and 5-FU (CF) in patients with metastatic or recurrent esophageal cancer (JCOG1314, MIRACLE study)
Japan Clinical Oncology Group (JCOG)0 sites240 target enrollmentSeptember 10, 2014
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Japan Clinical Oncology Group (JCOG)
- Enrollment
- 240
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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