Resected pancreatic adenocarcinoma Cancer Malignant neoplasm of pancreas
Conditions
Interventions
The clinical trial CapRI II is subdivided into three different interventional study arms:
1. Arm A: cisplatin, 5-fluorouracil, INTRON A® and external beam radiation (CapRI)
2. Arm B: 5-fluorouracil, I
patients in arm A receive additional cisplatin.
Dosage, frequency:
1. First cycle of 5-FU: 200 mg/m^2/day by continuous intravenous infusion days 1 - 38
2. Second and third cycle 5-FU: 200/mg/m^2/day
maximum single cisplatin dose of 60 mg) intravenously (IV) over 60 minutes on days 1, 8, 15, 22, 29, 36 (6 doses). Two to three hours before and after cisplatin dose the patients will receive hydratio
Sponsors
University of Heidelberg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is the comparison of the treatment groups with respect to event-free survival. Primary endpoint: 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
| Measure | Time frame |
|---|---|
| Secondary objectives are comparison of the treatment groups with respect to safety, overall survival (OS), reccurence-free survival (RFS), quality of life (QoL) and an accompanying immuno-monitoring to screen for predictive marker and to analyse the mode of action of IFN-alpha. Secondary endpoints: 1. Overall survival (OS), defined both as time from randomisation and resection to death 2. Recurrence-free survival (RFS) defined both as time from randomisation and resection or death from any cause (whichever occurs first) Time from resection to OS/RFS is important for comparability with other randomised controlled trials (RCTs) for adjuvant treatment of pancreatic carcinoma 3. Quality of life (QoL): European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) and EORTC Quality of Life Questionnaire for Pancreatic cancer (QLQ PAN26) 4. Immunological parameters: the translational research will be based on the immunological parameters (vascular endothelial growth factor [VEGF], basic fibroblast growth factor [bFGF], interleukin-2 [IL-2], interferon-alpha [IFN-alpha], tumour necrotising factor [TNF-alpha], interleukin-12 [IL-12], soluble MHC class I chain related molecules [sMIC], inactivated C3b complement [iC3b], etc.,). For each parameter, several (longitudinal) measurements will available. Apart from the parameter values themselves, further parameters will be generated, such as differences, or relative differences, of values after versus before administration of IFN-alpha, or binary variables obtained by applying threshold values. | — |
Countries
Germany
Outcome results
None listed