CONKO-007Significance of Chemoradiation Following Induction Chemotherapy in Locally Advanced,Unresectable Pancreatic Cancer -a Randomised Phase 3 Trial: Chemoradiation Following Induction Chemotherapy Compared With Chemotherapy Alone

Date de début de l'étude : 4 avril 2013

Inclusion Criteria: Age > 18 years histologically confirmed adenocarcinoma of the pancreas no evidence of distant metastasis based on computed tomography of the thorax and abdomen non resectable pancreatic cancer no evidence of peritoneal carcinosis ECOG-performance status ≤ 2 signed study-specific consent form prior to therapy Exclusion Criteria: fertile patients who refuse effective contraception during study treatment synchron second malignant neoplasm except basal cell carcinoma of the skin and carcinoma in situ of the cervix after curative therapy the Inclusion of patients with prior or concurrent malignancy (≤ 5 years prior to enrolment in study) must be discussed chronic inflammatory disease of the intestine known allergic reactions on study medication on-treatment participation on other trials insufficient liver function: Bilirubin > 2,0 mg/dl; SGOT, SGPT, alkaline phosphatase, gGT more than 3 times upper limit of normal (after Stent implantation in case of obstructive jaundice); cirrhosis of the liver Child B and C insufficient bone marrow function: WBC < 3,0 x 10^9/l, Platelets > 100 x 10^9/l serum creatinine > 1,5 mg/dl, creatinin clearance < 60ml/min (or comparable test) preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy, myocardial infarction within the past 6 months, unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) class III or IV heart disease neurological and/or psychiatric diseases: stroke, dementia, epilepsy, psychosis active intractable or uncontrollable infection, HIV-infection prior radiotherapy or chemotherapy