MISTRAL - Mistletoe therapy in primary and recurrent inoperable pancreatic cancer - A phase III prospective, randomized, double blinded, multicenter, parallel group, placebo controlled clinical trial on overall survival and health-related quality of Life - MISTRAL (short term for MIStletoe TRiAL)

Center for Digestive Diseases, Karolinska University Hospital0 个研究点开始时间: 2016年1月19日最近更新: 2017年7月24日

试验速览

暂无简介。

•Signed written informed consent
•Age = 18 years
•Histological confirmed inoperable locally advanced or metastatic pancreatic cancer or relapse of pancreatic cancer.
•- Primary diagnosis: if histology is not possible diagnosis is to be confirmed according to local practice sufficient for diagnosis and choice of therapy (such as CA19-9 and CT).
•- Relapse: histology (not required) or diagnosis according to local practice such as clinical signs and/or imaging and/or CA19-9.
•ECOG performance status 0-2
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 240

•Life expectancy less than 4 weeks
•Pregnancy or breastfeeding
•Neuroendocrine tumors of the pancreas (NET)
•Current use of interferon, G-CSF and thymus preparations
•Symptomatic brain edema due to brain metastases
•Known hypersensitivity to mistletoe-containing products
•Current use of mistletoe extract preparations in any form
•Previous, ongoing or planned irreversible electroporation (IRE)
•Chronic granulomatous disease or active autoimmune disease or autoimmune disease with immunosuppressive treatment
•Medical, psychiatric, cognitive or other conditions that may compromise the patient´s ability to understand the patient information, give informed consent, comply with the study protocol or complete the study (e.g. needle phobia).

发起方

Center for Digestive Diseases, Karolinska University Hospital