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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018682-31 | EudraCT Number |
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| Name | Class |
|---|---|
| Hiscia Society for Cancer Research | UNKNOWN |
| IFAG Basel AG (CRO), both Switzerland | UNKNOWN |
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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 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.
see summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival time (DFS). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score |
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Inclusion Criteria:
Exclusion Criteria:
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All patients visiting the center with colorectal cancer stage UICC II-IV and meeting the eligibility criteria will be asked to participate.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerhard M Stauder, PhD | Contact | +49 (8171) 96269 | stauder@ifag.biz |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Seufferlein, Prof. M.D. | University Clinic Halle (Saale) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 5th Med., Clinic Hietzing | Recruiting | Vienna | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20021637 | Background | Ostermann T, Raak C, Bussing A. Survival of cancer patients treated with mistletoe extract (Iscador): a systematic literature review. BMC Cancer. 2009 Dec 18;9:451. doi: 10.1186/1471-2407-9-451. | |
| 19883529 | Background | Friedel WE, Matthes H, Bock PR, Zanker KS. Systematic evaluation of the clinical effects of supportive mistletoe treatment within chemo- and/or radiotherapy protocols and long-term mistletoe application in nonmetastatic colorectal carcinoma: multicenter, controlled, observational cohort study. J Soc Integr Oncol. 2009 Fall;7(4):137-45. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 1 year |
| Interim analysis on overall survival time (OS) in UICC stage IV patients | 2 years |
| Safety of Iscador® Qu (number of patients with systemic or local adverse events (AE) to Iscador® Qu) | Adverse events (local and/or systemic) contributable to Iscador® Qu | 5 years |
| Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy). | 1 year |
| University Vienna | Recruiting | Vienna | Austria |
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| Augusta Clinic | Recruiting | Bochum | Germany |
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| MVZ Fulda | Recruiting | Fulda | Germany |
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| University Clinic - Internal Medicine I | Recruiting | Halle | 06120 | Germany |
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| Hospital Herdecke, private University | Recruiting | Herdecke | Germany |
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| Med. Clinic III, University Munich, Grosshadern | Recruiting | Munich | Germany |
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| Clinic Kloster Paradiese | Recruiting | Soest | Germany |
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| Med 1, University Clinic Ulm | Recruiting | Ulm | Germany |
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| 18955241 | Background | Ziegler R. Mistletoe Preparation Iscador: Are there Methodological Concerns with Respect to Controlled Clinical Trials? Evid Based Complement Alternat Med. 2009 Mar;6(1):19-30. doi: 10.1093/ecam/nem121. Epub 2007 Oct 4. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |