Pancreatic cancer adjuvant therapy after R1-resection Gemcitabine plus Sorafenib vs. Gemcitabine plus Placebo is given over 12 months randomised trial
Conditions
Interventions
Trade Name: Nexavar
Product Name: Sorafenib
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sorafenib Tosylate
Current Sponsor code: BAY 43-9006
Other descriptive name: Nexavar
Concentrat
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: R-resection histologically confirmed diagnosis of an adenocarcinoma of the pancreas no previous anticancer treatment karnofsky performance >=60% compliance signed informed consent sufficient blood cell count age >= 18 years beginning of the chemotherapy between week 4-8 post OP, wound healing must be completed 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
Exclusion criteria: Other serious illnesses: uncontrolled hypertension, congestive heart failure (NYHA II-IV), coronary heart disease, myocardial infarction within the last 12 months, cardiac arrhythmias, occlucive arterial disease, hemoptysis Active infection >grad 2 NCI-CTCAE v3.0 Pregnant or breastfeeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to start of treatment Impaired renal or liver function Patients undergoing renal dialysis Enrollment in another clinical trial within the last 4 weeks. Drug or alcohol abuse Non healing wounds Known or suspected allergy to the investigational agent or any agent given in association with this trial. Known (at time of entry) gastrointestinal disorder, including malabsorption or active gastric ulcer, present to the extent that it might interfere with oral intake and absorption of study medication. Any previous or concurrent malignancy or any cancer unless curatively treated > 3 years prior to study entry except cervical carcinoma in situ or adequate basal cell carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to comparate the disease free survival in both treatment groups;Secondary Objective: to comparate overall survival in both treatment groups security and toxicity to evaluate prognostic factors;Primary end point(s): to compare disease free survival in both treatment groups relapse of the pancreatic cancer | — |
Countries
Germany
Outcome results
None listed