ISRCTN79802092已完成不适用
A randomised multicentre phase II trial comparing adjuvant therapy in patients with resected pancreatic adenocarcinoma treated with interferon alpha-2b and 5-fluorouracil (5-FU) alone or in combination with either external radiation treatment and cisplatin (CapRI) or radiation alone regarding event-free survival
niversity of Heidelberg (Germany)0 个研究点目标入组 135 人开始时间: 2008年5月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
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
- 性别
- All
入选标准
- •As of 02/10/2008, point two of the initial inclusion criteria has been amended as follows:
- •2. Adequate laboratory parameters:
- •2.1. Bone marrow, liver and kidney function
- •2.2. Haemoglobin (Hb) greater than 8.0 g/dl, white blood cell count (WBC) greater than 3,000 cells/mm^3, platelets greater than 75,000 cells/mm^3
- •2.3. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to 1.5 mg/dL
- •2.4. Calculated or measured creatinine clearance (CrCl) of greater than or equal to 60 ml/min)
- •All other points have remained the same.
- •Initial criteria at time of registration:
- •Patients meeting all of the following criteria will be considered for admission to the trial:
- •1. R0/R1 resected pancreatic ductal adenocarcinoma
- •2. Adequate laboratory parameters:
- •2.1. Bone marrow, liver and kidney function
- •2.2. Haemogoblin [Hb] greater than 8.0 g/%, white blood cell count [WBC] greater than 3,000 cells/mm^3, platelets greater than 75,000 cells/mm^3
- •2.3. Alanine aminotransferase [ALT]/aspartate aminotransferase [AST] less than or equal to 2 x upper limit of normal [ULN]
- •2.4. Creatinine less than or equal to 1.5 mg/dL and calculated or measured creatinine clearance (CrCl) of greater than or equal to 60 ml/min
- •3. Therapy starts within eight weeks after surgery
- •4. Ability of patient to understand character and individual consequences of clinical trial
- •5. Written informed consent must be available before enrolment in the trial
- •6. For women with childbearing potential, adequate contraception
- •7. Age greater than or equal to 18 years, either sex
排除标准
- •As of 02/10/2008, point five of the initial exclusion criteria has been amended as follows:
- •5. Patients with severe heart diseases (New York Heart Association [NYHA] stadium three and four) or severe lung disease (chronic obstructive pulmonary disease [COPD] Grade III, Asthma bronchiale Grade IV)
- •At this time, the following exclusion criteria were also added:
- •10. General condition worse than Eastern Cooperative Oncology Group (ECOG) grade 2
- •11. Any contraindication met for any investigational product
- •12. Serious uncontrolled acute infections at the time of therapy initiation or patients with known HIV infection, other immunodeficiencies or autoimmune diseases
- •Initial criteria at time of registration:
- •Patients presenting with any of the following criteria will not be included in the trial:
- •1. Metastatic disease
- •2. Previous chemo- or radiotherapy for pancreatic carcinoma
- •3. Previous radiotherapy in the corresponding region
- •4. Patients with known severe depression
- •5. Patients with severe heart or lung disease
- •6. Pregnancy and lactation
- •7. 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
- •8. Patients with mental diseases (International Classification of Diseases version 10 [ICD-10] code F30, F31, F32.2 ff. or F33.2 ff.)
- •9. Participation in other clinical trials and observation period of competing trials, respectively
- •No patient will be allowed to enrol in this trial more than once.
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