EUCTR2008-000121-19-DE
Active, not recruiting
Not Applicable
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 sitesJune 17, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with Resected Pancreatic Adenocarcinoma
- Sponsor
- niversity of Heidelberg
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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