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Phase II trial of perioperative chemotherapy for esophageal cancer

Phase 2
Conditions
esophageal cancer
Registration Number
JPRN-UMIN000020204
Lead Sponsor
Kyoto university hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
50
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) Positive HBs antigen, or positive HCV antibody. 4) Pregnancy, possible pregnancy or breastfeeding. 5) Psychiatric disease. 6) Patients who need flucitosine, fenitoin or warfarin. 7) Poorly controlled diabetes mellitus 8) Severe pulmonary fibrosis or emphysema. 9) Serious angina or myocaedial infarcion within 3 months 10) Patients whom principle/sub-investigator judged ineligible to participate in this study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Three-year relapse free survival
Secondary Outcome Measures
NameTimeMethod
Overall survival, time to treatment free survival, treatment completion rate, incidence of adverse events, incidence of treatment related death
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