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Clinical Trials/JPRN-jRCTs051180082
JPRN-jRCTs051180082
Recruiting
Phase 1

Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU for clinical stage IA-IIIC esophageal cancer.(PCF-RT) - Phase I study of PCF-RT

Yamamoto Sachiko0 sites24 target enrollmentFebruary 28, 2019

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Esophageal cancer
Sponsor
Yamamoto Sachiko
Enrollment
24
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 28, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Yamamoto Sachiko

Eligibility Criteria

Inclusion Criteria

  • 1\) Histologically proven squamous cell carcinoma, or adenosquamous cell carcinoma or basaloid of the esophagus
  • 2\) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae)
  • 3\) Aged 20 to 75 years old
  • 4\) ECOG PS of 0 or 1
  • 5\) Clinical stage IA \- IIIC
  • 6\) No need for measurable lesion
  • 7\) No previous treatment of esophageal cancer except endoscopic surgery
  • 8\) No palsy of recurrent nerve
  • 9\) No adaptation of surgery or refused esophagectomy
  • 10\) Adequate organ functions

Exclusion Criteria

  • 1\) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer or expected cure in surgery
  • 2\) history of radiotherapy for mediastinum
  • 3\) Uncontrollable diabetes mellitus
  • 4\) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac function disorder
  • 5\) Uncontrollable arrhythmia
  • 6\) Patients requiring systemic steroids medication
  • 7\) Liver cirrhosis
  • 8\) Active bacterial or fungous infection
  • 9\) With a history of grade 2\-4 allergic reaction by CTCAE version 4\.0
  • 10\) With a history of grade 2\-4 nerve disturbance by CTCAE version 4\.0

Outcomes

Primary Outcomes

Not specified

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