Phase II study of chemoradiotherapy with 5-FU plus cisplatin followed by S-1 for clinical stage IA esophageal cancer

Phase 2

Recruiting

• Conditions: Esophageal cancer

• Registration Number: JPRN-jRCTs051180094
• Lead Sponsor: Takehara Tetsuo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Clinical stage IA (cT1a or cT1bN0M0) esophageal cancer (Histologically proven squamous cell carcinoma of the esophagus)
2) Aged >= 20 years old
3) ECOG PS of 0 or 1
4) Adequate food intake
5) No esophageal cancer including HGIN out of radiation field
6) Adequate organ functions
a) WBC: >=3,000/mm3, <12,000/mm3
b) Neu: >=1,500/mm3c) Hb: >=9.0g/dl
d) Plt: >=100,000/mm3
e) T.bil: <2.0mg/dl
f) AST/ALT: <150IU/L
g) Cr: <1.2mg/dl
h) CCr: >=50ml/min (in favor of the prediction formula of Cockcroft-Gault: Male; CCr = body weight x (140-age) / (72 x Cr), Female; CCr= body weight x (140-age) / (72 x Cr) x 0.85)
7) Written informed consent

Exclusion Criteria

1) Previous treatment with pyrimidine fluoride drug or platinum within 5 years
2) With active diseases (interstitial pneumonia, fibroid lung, intestinal obstruction, uncontrollable diabetes millutus or hypertentsion, history of myocardial infarction within 6 months, or unstable angina pectoris, liver cirrhosis, renal failure)
3) Simultaneous or metachronous cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer
4) History of severe allergic reactions to pyrimidine fluoride drug or platinum
5) Active infection
6) Positive HBs antigen
7) Previous radiotherapy to chest
8) With severe diarrhea
9) Psychosis
10) Pregnant or lactating women, women of childbearing potential or women who like to have children in future
11) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
12) Any patients judged by the investigator to be unfit to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival, complete response rate, relative dose intensity, toxicity