EUCTR2015-002288-41-DE进行中（未招募）1 期
Open-label pilot Phase I / II study on hyperthermic intraperitoneal chemotherapy ( HIPEC ) after macroscopically complete resection ( R0 / R1 ) of adenocarcinomas of the pancreas ( PanHIPEC )
niversity Department of General, Visceral and Transplant Surgery Tuebingen0 个研究点目标入组 16 人开始时间: 2015年8月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
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
- •= 18 years
- •CT morphologically suspected pancreatic tumor without distant metastases , with the possibility of a macroscopically complete resection ( R0 / R1 ) .
- •Histological diagnosis of adenocarcinoma of the pancreas ' in the frozen section intraoperatively
- •Karnofsky Index > 70
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Patients who are considered inoperable because of reduced general condition:
- •- Congestive heart failure (NYHA III / IV)
- •- Severe coronary heart disease, non-treatable arrhythmia or non-adjustable hypertension,
- •- Severe asthma suffering (COPD)
- •- Renal insufficiency (serum creatinine = 1.5x of normal, or creatinine clearance <60 ml / min.).
- •patients where the intra-operative frozen section no adenocarcinoma of the pancreas can be demonstrated
- •Patients suffering from a second malignancy (within 5 years in the study of consent) except basal cell carcinoma and curative treated in-situ carcinoma of the cervix
- •distant metastases (M> 0)
- •Patients with a contraindication related to the present study
- •allergy or intolerance to the study drug or a substance with chemical similarity to the study medication.
- •Patients under legal custodianship (For Example for significant psychiatric disabilities, etc.) or incarcerated patients
- •Patients That can not understand the purpose of the study due to mental, intellectual or linguistic problem.
- •Participation in Clinical Trials or other observation period of competing trials.
- •Females during pregnancy and lactation
- •Females of childbearing potential (FCBP) That do not agree
- •- To utilize two reliable forms of contraception or practice complete abstinence from Simultaneously heterosexual contact for at least 28 days before start of treatment and for at least 28 days after administration of study treatment
- •- To abstain from breastfeeding during study participation and 6 months after study treatment.
- •Males That do not agree
- •-to use a latex condom during any sexual contact with FCBP during participation in the study and for at least 28 days study Following treatment, even if he has undergone a successful vasectomy
- •-to refrain from donating semen or sperm for at least 28 days after study treatment.
研究者
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