Phase II trial of PerIoperativE Chemotherapy for Esophageal cancer

Phase 2

• Conditions: Esophageal cancer; C151

• Registration Number: JPRN-jRCTs051180154
• Lead Sponsor: Muto Manabu

Brief Summary

Adjuvant S-1 showed promising efficacy with manageable safety profile for patients with resectable ESCC after neoadjuvant chemotherapy followed by surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-25
• Study Completion: 2022-01-20
• Results First Posted: 2022-06-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus 2) Primary lesion are located within the thoracic esophagus (Te) 3) Clinical stage IB-III(without T4 disease) 4) Aged 20 to 75 years old 5) ECOG PS of 0 or1 6) Performed neoadjuvant chemotherapy (5-FU+cisplatin) 7) No previous treatment of esophageal cancer except EMR or ESD 8) Adequate organ functions 9) Resectable disease (R0) 10) Written informed consent

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