Comparison of three different therapies (radio-, chemo- and immunotherapy) in patients with resected pancreatic adenocarcinoma
- Conditions
- Resected pancreatic adenocarcinomaCancerMalignant neoplasm of pancreas
- Registration Number
- ISRCTN79802092
- Lead Sponsor
- niversity of Heidelberg (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 135
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective is the comparison of the treatment groups with respect to event-free survival. <br><br>Primary endpoint: <br>Event-free survival (EFS) - EFS is defined as time from resection to objective tumour recurrence, grade 3 or grade 4 toxicity (according to Common Toxicity Criteria version three [CTC 3.0]), or death (whichever occurs first).
- Secondary Outcome Measures
Name Time Method