Overview

This trial is active, not recruiting.

Condition pancreas cancer
Sponsor IFAG AG
Collaborator Hiscia Society for Cancer Research
Start date September 2010
End date December 2015
Trial size 220 participants
Trial identifier NCT01448668, 2010-018683-17, ISC-4.1.6

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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).
The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).

Primary Outcomes

Measure
Overall survival time (OS).
time frame: 3 years

Secondary Outcomes

Measure
Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)
time frame: 1 year
Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score
time frame: 1 year
Safety of Iscador® Qu (number of patients with systemic or local AE to Iscador® Qu)
time frame: 3 years
Number of patients with adverse events (AE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Prospective Epidemiological Study to Expand Knowledge on Efficacy and Safety of a Routine Post-operative Supportive Therapy With the Mistletoe Extract Iscador® Qu Within Oncological Treatment of Pancreatic Cancer Stages UICC II-IV
Principal investigator Volker Heinemann, Prof. MD
Description see summary
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by IFAG AG.