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

• Conditions: Pancreas Cancer

• Registration Number: NCT01448668
• Lead Sponsor: IFAG AG

Brief 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.

Detailed Description

see summary

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-01
• Last Update Posted: 2013-07-02
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival time (OS).	3 years

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events (AE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).	1 year
Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)	1 year	As key symptom, the fatigue syndrome will be evaluated separately.
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

Trial Locations

Locations (9)

5th Med., Clinic Hietzing; 🇦🇹 Vienna, Austria

University Clinic - Internal Med. I; 🇩🇪 Halle (Saale), Germany

University Vienna; 🇦🇹 Vienna, Austria

MVZ Fulda; 🇩🇪 Fulda, Germany

Augusta Clinic; 🇩🇪 Bochum, Germany

University Clinic Ulm; 🇩🇪 Ulm, Germany

Hospital Herdecke; 🇩🇪 Herdecke, Germany

Med. Clinic III, University Munich Grosshadern; 🇩🇪 Munich, Germany

Clinic Kloster Paradiese; 🇩🇪 Soest, Germany