Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)
Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with colorectal cancer (Union for International Cancer Control, UICC stages II-IV), in addition to post-operative 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 5 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.
|Study Design:||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 Colorectal Cancer Stages UICC II-IV|
- Disease-free survival time (DFS). [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life) [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Interim analysis on overall survival time (OS) in UICC stage IV patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Safety of Iscador® Qu (number of patients with systemic or local adverse events (AE) to Iscador® Qu) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Adverse events (local and/or systemic) contributable to Iscador® Qu
- Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448655
|Contact: Gerhard M Stauder, PhD||+49 (8171) email@example.com|
|Contact: Leo Auerbach, Prof. MD|
|5th Med., Clinic Hietzing||Recruiting|
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|Contact: Dirk Behringer, Prof. MD|
|Contact: Andrea Distelrath, MD|
|University Clinic - Internal Medicine I||Recruiting|
|Halle (Saale), Germany, 06120|
|Contact: Thomas Seufferlein, Prof. M.D.|
|Principal Investigator: Thomas Seufferlein, Prof. M.D.|
|Hospital Herdecke, private University||Recruiting|
|Contact: Florian Glaser, MD|
|Med. Clinic III, University Munich, Grosshadern||Recruiting|
|Contact: Volker Heinemann, Prof. MD|
|Clinic Kloster Paradiese||Recruiting|
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|Med 1, University Clinic Ulm||Recruiting|
|Contact: Götz PL von Wichert, MD|
|Principal Investigator:||Thomas Seufferlein, Prof. M.D.||University Clinic Halle (Saale)|