JPRN-jRCTs031180319进行中（未招募）2 期
Randomized phase II/III study of gemcitabine and nab-paclitaxel therapy versus S-1 and concurrent radiotherapy as neoadjuvant treatment for Borderline resectable pancreatic cancer - GABARNANCE Trial
Ikeda Masafumi0 个研究点目标入组 110 人开始时间: 2019年3月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
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 <= 79age old（—）
- 性别
- All
入选标准
- •1. Borderline resectable pancreatic cancer
- •2. Adenocarcinoma or adenosquamous carcinoma
- •3. No distant metastasis
- •4. Age 20-79
- •5. ECOG PS 0-1
- •6. No prior abdominal radiation therapy
- •7. No history of chemotherapy within last 3 years
- •8. No prior therapy for pancreatic cancer
- •9. Included in the irradiation field of 10cm x10cm
- •10. Able to eat orally
- •11. No sensory or motor neuropathy
- •12. Appropriate biliary drainage if bile duct obstructed
- •13. No radiological evidence of apparent intestinal cancer invasion and history of gastrointestinal bleeding
- •14. Meet all the criteria of laboratory examination
- •15. Informed consent by patient
排除标准
- •1. History of gemcitabine, nab-paclitaxel and fluorouracil
- •2. poor control of diarrhea
- •3. Use of Coumadin, Phenytoin and Flucytosine
- •4. Allergic to gemcitabine and nab-paclitaxel
- •5. Computed tomography contrast media allergy
- •6. Intestinal pneumonia
- •7. Moderate amount of ascites or pleural effusion
- •8. Active infection
- •9. Poor control of diabetes mellitus
- •10. Ongoing active other malignancy
- •11. Active peptic ulcer
- •12. Serious comorbid conditions
- •13. Myocardial infarction within last 6 months
- •14. Systemic steroid therapy
- •15. Serious psychiatric diseases
- •16. Planning a baby or pregnancy
- •17. Planning a baby
- •18. Judged unable to guarantee safety
研究者
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