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

JRCT ID: jRCTs051180094

Registered date:06/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 16/12/2014
• Target sample size: 30
• Study type: Interventional
• Intervention(s): S-1 administration

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Overall survival, complete response rate, relative dose intensity, toxicity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takehara Tetsuo
• Secondary ID(s): UMIN000015938