Iscador Qu As Supportive Treatment In Pancreatic Cancer (Union For International Cancer Control, UICC Stages II-IV)

Study Overview

Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)

Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with pancreatic cancer (Union for International Cancer Control, UICC stages II-IV), in addition to conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only. Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (DFS, OS) after 3 years. Prospective observational confirmation study of previous retrospective cohort study. As this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.

see summary

Pancreas Cancer

ISC-4.1.6
2010-018683-17 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-03-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-07-01
First Submitted that Met QC Criteria 2011-10-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-07-02
First Posted (ESTIMATED) 2011-10-07	Results First Posted N/A	Last Verified 2013-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Test group with Iscador® Qu The test group will receive the mistletoe extract Iscador® Qu as supportive treatment in addition to post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).
: Control group The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).

Primary Outcome Measures	Measure Description	Time Frame
Overall survival time (OS).		3 years

Secondary Outcome Measures	Measure Description	Time Frame
Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)	As key symptom, the fatigue syndrome will be evaluated separately.	1 year
Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score		1 year
Safety of Iscador® Qu (number of patients with systemic or local AE to Iscador® Qu)		3 years
Number of patients with adverse events (AE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).		1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Confirmed diagnosis of pancreatic cancer, adenocarcinoma, UICC stage II-IV
Age between 18 (Austria: 19) and 85 years
No previous malign tumor
ECOG 0-2
Estimated life expectancy > 3 months
Surgical resection of the tumor (R0, R1) or determination of interoperability
Conventional oncological therapy and measurements, or passive after-care ("best care")
Follow-up for several years feasible
Patient gives written consent to use the anonymized date for evaluation

Other Iscador® sorts than Qu in the test group
Other mistletoe preparations in the test group
Any mistletoe preparation in the control group
Non-oncological immunomodulating, -stimulating or -suppressive drugs (e.g. Echinacea, interferons, Polyerga®, BCG, azathioprine). Allowed are approved tumor inhibiting immuno- or targeted therapies (e.g. bevacizumab, cetuximab) and tumor specific vaccines
HIV infection, Aids, organ transplantation
Contraindications for Iscador® Qu (allergy against mistletoe, acute inflammatory disease or fever > 38.5°C, active tuberculosis, hyperthyreosis with not-adjusted metabolism, primary brain or spinal tumor, brain metastases)
Patients participating in another clinical study with non-approved substances

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Hiscia Society for Cancer Research
IFAG Basel AG, both Switzerland

Investigators

PRINCIPAL_INVESTIGATOR: Volker Heinemann, Prof. MD, Med. Clinic III, University Clinic Munich Grosshadern

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record