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

Charité - Universitätsmedizin Berlin0 个研究点目标入组 162 人开始时间: 2007年10月18日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•R-resection
•histologically confirmed diagnosis of an adenocarcinoma of the pancreas
•no previous anticancer treatment
•karnofsky performance >=60%
•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

发起方