ESOX trial

JRCT ID: jRCTs051180192

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: adenocarcinoma of the esophagogastric junction
• Date of first enrollment: 26/03/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Three courses of S-1+oxaliplatin (L-OHP 130mg/m2 div 2h day1, S-1 80-120 mg/body p.o. day1 evening~day15 morning ) are given by 3-week interval, prior to the surgery.

Outcome(s)

• Primary Outcome: R0 rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

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

Include criteria

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

Exclude criteria

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.

Related Information

• Primary Sponsor: Watanabe Masayuki
• Secondary ID(s): UMIN000020815