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

Pancreas Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01448668
• Other study ID #: ISC-4.1.6
• Secondary ID: 2010-018683-17
• Status: Active, not recruiting
• Phase: N/A
• First received: March 30, 2011
• Last updated: July 1, 2013
• Start date: September 2010
• Est. completion date: June 2016

Study information

• Verified date: July 2013
• Source: IFAG AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Description:

see summary

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Austria	5th Med., Clinic Hietzing	Vienna
Austria	University Vienna	Vienna
Germany	Augusta Clinic	Bochum
Germany	MVZ Fulda	Fulda
Germany	University Clinic - Internal Med. I	Halle (Saale)
Germany	Hospital Herdecke	Herdecke
Germany	Med. Clinic III, University Munich Grosshadern	Munich
Germany	Clinic Kloster Paradiese	Soest
Germany	University Clinic Ulm	Ulm

Sponsors (3)

Lead Sponsor	Collaborator
IFAG AG	Hiscia Society for Cancer Research, IFAG Basel AG, both Switzerland

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival time (OS).		3 years	No
Secondary	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	No
Secondary	Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score		1 year	No
Secondary	Safety of Iscador® Qu (number of patients with systemic or local AE to Iscador® Qu)		3 years	Yes
Secondary	Number of patients with adverse events (AE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).		1 year	No