Chemoradiation following induction chemotherapy in locally advanced, unresectable pancreatic cancer -a randomised phase 3 trial:Chemoradiation following induction chemotherapy compared with chemotherapy alone.

Dekan of the Medical Faculty of the University Erlangen-Nuremberg; Prof. Dr. med. Markus F. Neurath0 个研究点目标入组 830 人开始时间: 2012年12月20日最近更新: 2023年11月20日

试验速览

暂无简介。

•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
•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 830
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 830

•Pregnant or lactating/nursing women
•Fertile patients who refuse effective contraception during study treatment
•synchron second malignant neoplsam except basal cell carcinoma of the skin and carcinoma is 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 and after Stent implantation according to centre`s practice or after having consulted with PI); 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

发起方

Dekan of the Medical Faculty of the University Erlangen-Nuremberg; Prof. Dr. med. Markus F. Neurath