PhaseI/II trial of chemotherapy with docetaxel, CDDP and 5-Fluorouracil followed by chemoradiotherapy with CDDP and 5-Fluorouracil in patients with locally advanced esophageal cancer.
Phase 1
- Conditions
- esophageal cancer
- Registration Number
- JPRN-UMIN000003546
- Lead Sponsor
- Department of Surgical Oncology, Division of Clinical and Experimental Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1.History of hypersensitivity to DOC, CDDP, 5-FU, or polysorbate 80 2.With severe complication 3.Infection with fever elevation 4.Motor paralysis, peripheral neuropathy or edema 5.Pleural or pericardial effusion that requires treatment 6.Simultaneous or metachronous (within 5 years) double cancers. 7.Pregnant or lactating women 8.Interstitial pneumonia or fibroid lung 9.Psychosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PhaseI: Incidence of dose limiting toxicity PhaseII: Clinical response rate
- Secondary Outcome Measures
Name Time Method PhaseI: Adverse events, Clinical response rate PhaseII: Adverse events, Progression-free survival, Overall survival