PhaseI/II trial of neoadjvant chemoradiotherapy with docetaxel,CDDP and 5-Fluorouracil followed by surgery in patients with advanced esophageal cancer.

Phase 1

• Conditions: Esophageal Cancer

• Registration Number: JPRN-UMIN000002137
• 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

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-01
• Study Completion: 2014-11-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

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:Histopathological response rate

Secondary Outcome Measures

Name	Time	Method
PhaseI:Adverse events,Histopathological response rate PhaseII:Adverse events, Disease-free survival, Overall survival