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

• Conditions: Patients with Resected Pancreatic Adenocarcinoma; MedDRA version: 9.1Level: LLTClassification code 10033608Term: Pancreatic cancer resectable

• Registration Number: EUCTR2008-000121-19-DE
• Lead Sponsor: niversity of Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-17
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective is the comparison of the treatment groups with respect to event-free survival. An event is defined as tumor reccurence, grade 3 or grade 4 toxicity (according to CTC 3.0), or death (whichever occurs first). ;Secondary Objective: Secondary objectives are comparison of the treatment groups with respect to safety, OS, RFS, QoL and an accompanying immunomonitoring to screen for predictive marker and to analyze the mode of action of IFN-alpha.;Primary end point(s): Event-free survival (EFS)