Primary or recurrent inoperable pancreatic cancer
Conditions
Interventions
Trade Name: Iscador Qu
Product Name: Fermented aqueous extract of Viscum album ssp album (L.) (mistletoe)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Mistletoe extract
CAS Number
Sponsors
Center for Digestive Diseases, Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to compare mistletoe therapy to placebo in the endpoint overall survival (time from randomization to death of any cause) in palliative patients with inoperable pancreatic cancer. ;Secondary Objective: Key secondary objectives are to compare mistletoe therapy to placebo in the endpoints ”global health”, “physical function”, “fatigue” and “appetite loss” as scales of the EORTC QLQ-C30 questionnaire in palliative patients with inoperable pancreatic cancer. Other secondary objectives are to compare mistletoe therapy to placebo in the endpoints body weight, corticosteroid use, adverse events (AE) and costs for supportive care and inpatient care. ;Primary end point(s): Primary Endpoint is Overall Survival (OS) which is defined as time from randomization to death for any reason. ;Timepoint(s) of evaluation of this end point: At time of death and end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints are: scales for ”global health”, “physical function”, “fatigue” and “appetite loss” according to EORTC QLQ-C30 Other secondary endpoints are remaining scales for QoL according to EORTC QLQ-C30 and EORTC QLQ-PAN-26, body weight, corticosteroid use, adverse events (AE), costs for supportive care and costs for inpatient care ;Timepoint(s) of evaluation of this end point: At each visit in the study | — |
Countries
Sweden
Contacts
Public ContactClinnical Trial Unit
Center for Digestive Diseases, Karolinska University Hospital
Outcome results
None listed