Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)
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|ClinicalTrials.gov Identifier: NCT01448655|
Recruitment Status : Unknown
Verified July 2013 by IFAG AG.
Recruitment status was: Recruiting
First Posted : October 7, 2011
Last Update Posted : July 2, 2013
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||300 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 Colorectal Cancer Stages UICC II-IV|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
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).
- Disease-free survival time (DFS). [ Time Frame: 5 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 ]
- Interim analysis on overall survival time (OS) in UICC stage IV patients [ Time Frame: 2 years ]
- Safety of Iscador® Qu (number of patients with systemic or local adverse events (AE) to Iscador® Qu) [ Time Frame: 5 years ]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 ]
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): NCT01448655
|Contact: Gerhard M Stauder, PhD||+49 (8171) email@example.com|
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