EUCTR2011-000703-40-DK进行中（未招募）1 期
Clinical trial with chemotherapy for patients with non-resectable, locally advanced pancreatic cancer and addition of chemo-radiotherapy for patients with borderline resectable pancreatic cancer. DPSG - ”Danish Pancreatic cancer Study Group” - Folfirinox
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 53
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with histologically/cytologically proven pancreatic adenocarcinoma .
- •a.Patients can be included with appearance of malignant tumor cells at the cytological investigation or íf the investigator concludes that there is no indication for further biopsies.
- •2. UICC stadium IIA/IIB or III.
- •3. No lymphnode metastases outside the loco-regional area. That is what is expected to be removed by surgical resection.
- •4. 4.Patients with measurable or non-measurable disease according to RECIST version 1.1.
- •5. Performance status 0 and 1.
- •6. Normal liver function with bilirubin < 1.5 x upper normal limit (UNL).
- •7. Signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1. Major surgery within 4 weeks.
- •a. Including laparatomy
- •2. Other active malignant disease within the last 2 years.
- •3. Previous anti-neoplastic treatment for pancreatic cancer.
- •4. Previous radiotherapy to the abdomen which influence the specific radiation dose in the protocol.
- •5. Patients who are unable to follow treatment and evaluation plan.
- •6. Any condition or therapy which after the opinion of the investigator exposes the patient to a risk or interfere with the purpose of the trial.
- •7. Pregnant or lactating women.. In fertile women, this is done with a negative pregnancy test or use of safe anti-contraception (the pill) during the last 3 months before inclusion. Patients of childbearing potential must use effective anti-contraception (the pill) throughout the study treatment and at least 3 months after completion of study treatment.
- •8. Known hypersensitivity towards one of the components in the treatment.
- •9. Severe comorbidity.
- •a.Unstable angina or myocardial infarction within 12 months
- •b.NYHA class III & IV
研究者
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