Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)
This study is currently recruiting participants.
Verified October 2011 by IFAG AG
Sponsor:
IFAG AG
Collaborators:
Hiscia Society for Cancer Research
IFAG Basel AG (CRO), both Switzerland
Information provided by (Responsible Party):
IFAG AG
ClinicalTrials.gov Identifier:
NCT01448655
First received: March 29, 2011
Last updated: October 6, 2011
Last verified: October 2011
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Purpose
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 |
|---|
|
Colorectal Cancer |
| Study Type: | Observational |
| 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 |
Resource links provided by NLM:
Further study details as provided by IFAG AG:
Primary Outcome Measures:
- Disease-free survival time (DFS). [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 800 |
| 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) |
| Groups/Cohorts |
|---|
|
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).
|
Detailed Description:
see summary
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients visiting the center with colorectal cancer stage UICC II-IV and meeting the eligibility criteria will be asked to participate.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448655
Contacts
| Contact: Gerhard M Stauder, PhD | +49 (8171) 96269 | stauder@ifag.biz |
Locations
| Austria | |
| University Vienna | Recruiting |
| Vienna, Austria | |
| Contact: Leo Auerbach, Prof. MD | |
| 5th Med., Clinic Hietzing | Recruiting |
| Vienna, Austria | |
| Contact: Thomas Stein, MD | |
| Germany | |
| Augusta Clinic | Recruiting |
| Bochum, Germany | |
| Contact: Dirk Behringer, Prof. MD | |
| MVZ Fulda | Recruiting |
| Fulda, Germany | |
| 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 |
| Herdecke, Germany | |
| Contact: Florian Glaser, MD | |
| Med. Clinic III, University Munich, Grosshadern | Recruiting |
| Munich, Germany | |
| Contact: Volker Heinemann, Prof. MD | |
| Clinic Kloster Paradiese | Recruiting |
| Soest, Germany | |
| Contact: Eckhard Böcher, Prof. MD | |
| Med 1, University Clinic Ulm | Recruiting |
| Ulm, Germany | |
| Contact: Götz PL von Wichert, MD | |
Sponsors and Collaborators
IFAG AG
Hiscia Society for Cancer Research
IFAG Basel AG (CRO), both Switzerland
Investigators
| Principal Investigator: | Thomas Seufferlein, Prof. M.D. | University Clinic Halle (Saale) |
More Information
Publications:
| Responsible Party: | IFAG AG |
| ClinicalTrials.gov Identifier: | NCT01448655 History of Changes |
| Other Study ID Numbers: | ISC-4.1.5, 2010-018682-31 |
| Study First Received: | March 29, 2011 |
| Last Updated: | October 6, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by IFAG AG:
|
colorectal cancer mistletoe supportive treatment |
long-term study non-interventional cohort study controlled study with parallel groups |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Viscum album peptide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013