Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)
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|ClinicalTrials.gov Identifier: NCT01448668|
Recruitment Status : Unknown
Verified July 2013 by IFAG AG.
Recruitment status was: Active, not recruiting
First Posted : October 7, 2011
Last Update Posted : July 2, 2013
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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|
|Study Type :||Observational|
|Actual Enrollment :||220 participants|
|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|
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).
The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).
- Overall survival time (OS). [ Time Frame: 3 years ]
- 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.
- 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 ]
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|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|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448668
|5th Med., Clinic Hietzing|
|University Clinic - Internal Med. I|
|Halle (Saale), Germany|
|Med. Clinic III, University Munich Grosshadern|
|Clinic Kloster Paradiese|
|University Clinic Ulm|
|Principal Investigator:||Volker Heinemann, Prof. MD||Med. Clinic III, University Clinic Munich Grosshadern|
|Responsible Party:||IFAG AG|
|Other Study ID Numbers:||
2010-018683-17 ( EudraCT Number )
|First Posted:||October 7, 2011 Key Record Dates|
|Last Update Posted:||July 2, 2013|
|Last Verified:||July 2013|
non-interventional cohort study
controlled study with parallel groups
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases