Treatment with a mistletoe preparation for patients with inoperable pancreatic cancer. A double blind placebo controlled multicenter trial investigating whether survival and quality of life can be improved.

Phase 1

• Conditions: Primary or recurrent inoperable pancreatic cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004552-64-SE
• Lead Sponsor: Center for Digestive Diseases, Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-19
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>;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.<br>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. <br>;Primary end point(s): Primary Endpoint is Overall Survival (OS) which is defined as time from randomization to death for any reason.<br><br><br><br>;Timepoint(s) of evaluation of this end point: At time of death and end of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Key secondary endpoints are: scales for ”global health”, physical function”, fatigue” and appetite loss” according to EORTC QLQ-C30 <br>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<br><br><br><br><br>;Timepoint(s) of evaluation of this end point: At each visit in the study