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

Study Overview
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Brief Summary
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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.

Detailed Description
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see summary

Official Title
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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

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of colorectal cancer, UICC stage II-IV Age between 18 (Austria: 19) and 85 years No previous malign tumor Surgical resection of the tumor if indicated (Post-operative) 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: Anal cancer 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 High-dose systemic glucocorticoids 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) Known mistletoe intolerance Patients participating in another clinical study with non-approved substances

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test group with Iscador® Qu<br>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<br>The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival time (DFS). |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, mistletoe, supportive treatment, long-term study, non-interventional cohort study, controlled study with parallel groups