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Clinical Trials/JPRN-jRCT1051180068
JPRN-jRCT1051180068
Completed
Phase 2

A prospective study to verify the effectiveness of a element supplement Elental for patients who are administered TS-1 after surgical resection of pancreatic cancer - Elental adjuvant S-1 trial

Toyama Hirochika0 sites35 target enrollmentFebruary 19, 2019

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
pancreatic cancer
Sponsor
Toyama Hirochika
Enrollment
35
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The number of compatible cases was extremely small and could not be analyzed.

Registry
who.int
Start Date
February 19, 2019
End Date
December 28, 2020
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Toyama Hirochika

Eligibility Criteria

Inclusion Criteria

  • Eligebility Criteria during hospital state
  • 1\)patients 20 years old or more
  • 2\)proven pancreatic cancer histlogecally
  • 3\)confirmed by R0 or R1 surgery
  • 4\)PS (ECOG) between 0 and 2
  • 5\)wityout any prior chemotherapy and/or radiation therapy
  • 6\)with good oral intake
  • 7\)written informed consent to participate in this study
  • 8\)without any severe diseases and with a good condition of important organs for administration of TS\-1
  • a)WBC \>\= 2,500/mm3

Exclusion Criteria

  • Exclusion Criteria during hospital stay
  • 1\)with active double cancer (\*)
  • \*Simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years.
  • Carcinoma in situ or cancers localized in membranous layer are not included to double cancer.
  • Cancers removed by EMR/ESD are included.
  • 2\)with a history of allergy against TS\-1 and/or Elental
  • 3\)with active infection diseases
  • 4\)with uncontrollable hypertension
  • 5\)with uncontrollable DM
  • 6\)with severe heart diseases clinically

Outcomes

Primary Outcomes

Not specified

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