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Clinical Trials/JPRN-jRCT1031200325
JPRN-jRCT1031200325
Recruiting
Phase 1

Examination of the safety and usefulness of preoperative chemotherapy and radiation therapy for locally advanced pancreatic cancer (Phase I / II)

wagawa Tadashi0 sites58 target enrollmentJanuary 27, 2021

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
wagawa Tadashi
Enrollment
58
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 27, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
wagawa Tadashi

Eligibility Criteria

Inclusion Criteria

  • 1\) Patients who have been confirmed by histological or cytological examination to have pancreatic cancer.
  • 2\) Patients with locally advanced pancreatic cancer who do not have distant metastasis and the tumor has spread to the surrounding arteries and veins, making curative resection difficult.
  • 3\) Patients who have not received prior treatment for this disease prior to enrollment
  • 4\) Patients whose age at registration is 20 years or older and under 80 years old
  • 5\) Patients with Performance status (ECOG) of 0,1
  • 6\) Patients who are expected to survive for more than 3 months from the start of treatment
  • 7\) Patients who retain the functions of major organs (bone marrow, liver, kidneys, lungs, etc.)
  • 8\) Patients with sufficient urine output
  • 9\) Patients who can take orally
  • 10\) Patients with written consent

Exclusion Criteria

  • 1\) Patients with non\-curative factors during radical resection
  • 2\) Patients with overt pulmonary fibrosis or interstitial pneumonia
  • 3\) Patients with active infections (HB, HCV, HIV infections, etc.)
  • 4\) Patients with heart failure, angina, arrhythmia and myocardial infarction within 6 months of onset that are difficult to control despite treatment
  • 5\) Patients with uncontrollable diabetes
  • 6\) Patients with watery diarrhea
  • 7\) Patients using flucytosine and phenytoin
  • 8\) Pregnant women, lactating and patients with or willingness to become pregnant
  • 9\) Patients with severe drug allergies
  • 10\) Patients with active double cancer (not applicable to cases 5 years after complete cure)

Outcomes

Primary Outcomes

Not specified

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