Phase II trial of PerIoperativE Chemotherapy for Esophageal cancer

JRCT ID: jRCTs051180154

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 22/01/2016
• Target sample size: 50
• Study type: Interventional
• Intervention(s): S-1 80mg/m2/day is administered orally between day 1 and day 28. It takes 42 days for the one course. S-1 administration for 4 couses.

Outcome(s)

• Primary Outcome: Three-year relapse free survival
• Secondary Outcome: Overall survival, relapse free survival, time to treatment free survival, treatment completion rate, treatment continuation rate per time point, incidence of adverse events, incidence of treatment related death

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both
• Include 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
• Exclude 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.

Related Information

• Primary Sponsor: Muto Manabu
• Source(s) of Monetary Support: Taiho Pharmaceutical Co., Ltd.