CONKO-006 Additive Therapie beim R1-resezierten Pankreaskarzinom mit Gemcitabin plus Sorafenib versus Gemcitabin plus Placebo über 12 Monate - eine doppelblinde, placebokontrollierte Phase IIb Studie - CONKO-006
- Conditions
- Pancreatic canceradjuvant therapy after R1-resectionGemcitabine plus Sorafenib vs. Gemcitabine plus Placebo is given over 12 monthsrandomised trial
- Registration Number
- EUCTR2007-000718-35-DE
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 162
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to comparate the disease free survival in both treatment groups;Secondary Objective: to comparate overall survival in both treatment groups<br>security and toxicity<br>to evaluate prognostic factors;Primary end point(s): to compare disease free survival in both treatment groups<br>relapse of the pancreatic cancer
- Secondary Outcome Measures
Name Time Method