A phase II study of systemic chemotherapy with S-1 plus oxaliplatin followed by surgery in T3/T4a and/or lymph node-positive advanced adenocarcinoma of the esophagogastric junction

A phase II study of systemic chemotherapy with S-1 plus oxaliplatin followed by surgery in T3/T4a and/or lymph node-positive advanced adenocarcinoma of the esophagogastric junction - ESOX trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020815

Enrollment

Registered

2016-03-15

Start date

2016-04-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adenocarcinoma of the esophagogastric junction

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
R0 rate	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTakashi Ichimura

Cancer Institute Hospital Gastroenterological Chemotherapy Department

takashi.ichimura@jfcr.or.jp03-3520-0111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026