Examination of the safety and usefulness of preoperative chemotherapy and radiation therapy for locally advanced pancreatic cancer (Phase I / II)
- Conditions
- ocally advanced pancreatic cancer
- Registration Number
- JPRN-jRCT1031200325
- Lead Sponsor
- wagawa Tadashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 58
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
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)
11) Patients with other serious complications
12) Patients with severe neuropsychiatric symptoms and renal disorders
13) Patients with hearing impairment
14) Chickenpox patients
15) Patients with prior treatment history for this disease
16) Other patients who the doctor in charge judged to be inappropriate for conducting this study safely
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method