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.
Investigators
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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