Phase II study of chemoradiotherapy with S-1 plus cisplatin for clinical stage IA esophageal cancer (endoscopic resection followed by chemoradiotherapy)

Phase 2

• Conditions: clinical stage IA esophageal cancer

• Registration Number: JPRN-UMIN000014684
• Lead Sponsor: Osaka International Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-30
• Last Update Posted: 17 October 2023
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer 2) Patients requiring the administration of phenytoin or warfarin potassium 3) Uncontrollable diabetes millutus 4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac failure 5) Uncontrollable arrhythmia 6) Patients requiring systemic steroids medication 7) Liver cirrhosis 8) Active bacterial or fungous infection 9) With a history of grade 2-4 allergic reaction by CTCAE version 4.0 10) With grade 2-4 nerve disturbance by CTCAE version 4.0 11) With blood transfusion within 2 weeks and/or active bleeding 12) Interstitial pneumonia, fibroid lung or severe emphysema 13) With a history of allergic reaction to tegafur (FT), gimestat (CDHP) and otastat potassium (Oxo) 14) Psychosis 15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future 16) Any patients judged by the investigator to be unfit to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified