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

• ClinicalTrials.gov Identifier: NCT01448668
• Recruitment Status: Unknown
• First Posted: October 7, 2011
• Last Update Posted: July 2, 2013
• Sponsor: IFAG AG
• Collaborators: Hiscia Society for Cancer Research; IFAG Basel AG, both Switzerland
• Information provided by (Responsible Party): IFAG AG

Study Description

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.

Condition or disease
Pancreas Cancer

Detailed Description:

see summary

Study Design

• Study Type: Observational
• Actual Enrollment: 220 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: September 2010
• Estimated Primary Completion Date: December 2015
• Estimated Study Completion Date: June 2016

Groups and Cohorts

Group/Cohort
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).

Outcome Measures

Primary Outcome Measures :

1. Overall survival time (OS). [ Time Frame: 3 years ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All patients visiting the center with pancreatic cancer stage UICC II-IV and meeting the eligibility criteria will be asked to participate.

Criteria

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

Contacts and Locations

Locations

Austria

5th Med., Clinic Hietzing

Vienna, Austria

University Vienna

Vienna, Austria

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, Germany

Sponsors and Collaborators

IFAG AG

Hiscia Society for Cancer Research

IFAG Basel AG, both Switzerland

Investigators

• Principal Investigator: Volker Heinemann, Prof. MD; Med. Clinic III, University Clinic Munich Grosshadern

More Information

• Responsible Party: IFAG AG
• ClinicalTrials.gov Identifier: NCT01448668
• Other Study ID Numbers: ISC-4.1.6; 2010-018683-17 ( EudraCT Number )
• First Posted: October 7, 2011
• Last Update Posted: July 2, 2013
• Last Verified: July 2013

Keywords provided by IFAG AG:

pancreatic cancer; mistletoe; supportive treatment; long-term study; non-interventional cohort study; controlled study with parallel groups

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases