EUCTR2008-000121-19-DE进行中（未招募）不适用
A Randomized Multicentre Phase II Trial Comparing Adjuvant Therapy in Patients with Resected Pancreatic Adenocarcinoma Treated with Interferon Alpha-2b and 5-FU Alone or in Combination with Either External Radiation Treatment and Cisplatin (CapRI) or Radiation alone regarding Event-Free Survival - CapRI 2
niversity of Heidelberg0 个研究点开始时间: 2008年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-R0/R1 resected pancreatic ductal adenocarcinoma
- •-Adequate lab parameters (bone marrow-, liver and kidney function; Hb >8.0 g/dl, WBC >3,000 cells/mm³, platelets >75,000 cells/mm³; ALT/AST = 2 ULN; Creatinine ?1.5 mg/dL and calculated or measured creatinine clearance (CrCl) of = 60 ml/min).
- •-Therapy starts within eight weeks after surgery
- •-Ability of patient to understand character and individual consequences of clinical trial
- •-Written informed consent must be available before enrolment in the trial
- •-For women with childbearing potential, adequate contraception.
- •-Age = 18 years
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Metastatic disease
- •-Previous chemo- or radiotherapy for pancreatic carcinoma
- •-Previous radiotherapy in the corresponding region
- •-Patients with known severe depression
- •-Patients with severe heart diseases (NYHA stadium three and four) or severe lung disease (COPD Grade III, Asthma bronchiale Grade IV)
- •-General condition worse than ECOG 2
- •-Pregnancy and lactation
- •-History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product
- •-Any contraindication met for any investigational product
- •-Patients with mental diseases ICD-10-code F30, F31, F32.2 ff. or F33.2 ff.
- •-Participation in other clinical trials and observation period of competing trials, respectively.
- •-Serious uncontrolled acute infections at the time of therapy initiation or patients with known HIV infection, other immunodeficiencies or autoimmune diseases
研究者
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