ESOX trial
- Conditions
- adenocarcinoma of the esophagogastric junction
- Registration Number
- JPRN-jRCTs051180192
- Lead Sponsor
- Watanabe Masayuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
1) Pathologically proven adenocarcinoma of the esophagus.
2) Siewert type I or typeII with esophageal invasion over 3 cm.
3) T3/T4a and/or lymph node-positive (over 1cm )
4) Eligible for surgery with curative intent.
5) no prior therapy
6) An age of over 20
7) An ECOG performance status of 0 or 1
8) Major organs are in normal conditions.
Hemoglobin => 8.0g/dL
neutrophil count => 1,500/mm3
Platelet count => 100,000/mm3
Serum bilirubin <= 2.0 mg/dL
AST, ALT <= 100 IU/L
Serum creatinine <= 1.3 mg/dL
Creatinine clearance (or estimated GFR) => 60mL/min
9) Written informed consent must be taken by patients
1) Active synchronous or metachronous malignancy, excepting for early stage cancers
2) Active infectious diseases
3) Uncontrollable HBV infection
4) Pregnant or lactation women, or women with the possibility of the pregnancy.
5) Severe mental disorders, neurological disease
6) under systemic steroid therapy
7) under treatment of flucytosine, phenytoin or warfarin potassium
8) Iodoallergy
9) Unstable angina, or myocardial infarction within 6 months.
10) Patients who are judged inappropriate for the entry into this study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method R0 rate
- Secondary Outcome Measures
Name Time Method response rate, rate of the patients who completed the neoadjuvant treatment, pathological response rate, Perioperative complications rate, 2y recurrence free survivalrate, 3y recurrence free survival rate, overall survival, adverse event rate, severe adverse event rate