JPRN-jRCT1031200325招募中1 期
Examination of the safety and usefulness of preoperative chemotherapy and radiation therapy for locally advanced pancreatic cancer (Phase I / II)
wagawa Tadashi0 个研究点目标入组 58 人开始时间: 2021年1月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old(—)
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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