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Clinical Trials/JPRN-jRCTs051180192
JPRN-jRCTs051180192
Completed
Phase 2

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) - ESOX trial

Watanabe Masayuki0 sites50 target enrollmentMarch 26, 2019

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
adenocarcinoma of the esophagogastric junction
Sponsor
Watanabe Masayuki
Enrollment
50
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 26, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Watanabe Masayuki

Eligibility 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

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.

Outcomes

Primary Outcomes

Not specified

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