Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)
- Conditions
- Colorectal Cancer
- Registration Number
- NCT01448655
- Lead Sponsor
- IFAG AG
- Brief Summary
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
see summary
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival time (DFS). 5 years
- Secondary Outcome Measures
Name Time Method Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life) 1 year As key symptom, the fatigue syndrome will be evaluated separately.
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) 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). 1 year
Trial Locations
- Locations (9)
University Vienna
🇦🇹Vienna, Austria
Augusta Clinic
🇩🇪Bochum, Germany
Hospital Herdecke, private University
🇩🇪Herdecke, Germany
MVZ Fulda
🇩🇪Fulda, Germany
5th Med., Clinic Hietzing
🇦🇹Vienna, Austria
University Clinic - Internal Medicine I
🇩🇪Halle (Saale), Germany
Clinic Kloster Paradiese
🇩🇪Soest, Germany
Med 1, University Clinic Ulm
🇩🇪Ulm, Germany
Med. Clinic III, University Munich, Grosshadern
🇩🇪Munich, Germany