Colorectal CancerNCT01448655
Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)
An observational study of Colorectal Cancer, run by IFAG AG at 9 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 300 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Sep 2010to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients visiting the center with colorectal cancer stage UICC II-IV and meeting the eligibility criteria will be asked to participate.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany7 sites, 7 recruiting
- Recruiting
Augusta Clinic
Bochum
Dirk Behringer, Prof. MD
- Recruiting
MVZ Fulda
Fulda
Andrea Distelrath, MD
- Recruiting
University Clinic - Internal Medicine I
Halle, 06120
Thomas Seufferlein, Prof. M.D.
Thomas Seufferlein, Prof. M.D.
- Recruiting
Hospital Herdecke, private University
Herdecke
Florian Glaser, MD
- Recruiting
Med. Clinic III, University Munich, Grosshadern
Munich
Volker Heinemann, Prof. MD
- Recruiting
Clinic Kloster Paradiese
Soest
Eckhard Böcher, Prof. MD
- Recruiting
Med 1, University Clinic Ulm
Ulm
Götz PL von Wichert, MD
Austria2 sites, 2 recruiting
- Recruiting
5th Med., Clinic Hietzing
Vienna
Thomas Stein, MD
- Recruiting
University Vienna
Vienna
Leo Auerbach, Prof. MD
About this study
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
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.
Read more
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.
Read the detailed description
see summary
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, mistletoe, supportive treatment, long-term study, non-interventional cohort study, controlled study with parallel groups
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival time (DFS).
Measured: 5 years
Secondary outcomes (5)
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.
Measured: 1 year
Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score
Measured: 1 year
Interim analysis on overall survival time (OS) in UICC stage IV patients
Measured: 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
Measured: 5 years
Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IFAG AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hiscia Society for Cancer Research, IFAG Basel AG (CRO), both Switzerland
- Responsible party
- Sponsor
- Investigators
- Thomas Seufferlein, Prof. M.D., Principal investigator, University Clinic Halle (Saale)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448655
- Sponsor's protocol ID
- ISC-4.1.5
- Other IDs
- 2010-018682-31
- Status last verified
- Jul 2013
- First submitted
- 29 Mar 2011
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20021637Friedel 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.
PubMed 19883529Ziegler 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.
PubMed 18955241
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01448655
- Acronym / sponsor ID
- ISC-4.1.5
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, mistletoe, supportive treatment, long-term study, non-interventional cohort study, controlled study with parallel groups
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IFAG AGIndustry (pharma, biotech, devices)
- Collaborators
- Hiscia Society for Cancer Research, IFAG Basel AG (CRO), both Switzerland
- Study start
- Sep 2010
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients visiting the center with colorectal cancer stage UICC II-IV and meeting the eligibility criteria will be asked to participate.
Key inclusion criteria (7 listed)
- 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")
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-free survival time (DFS).
Time frame: 5 years
5 secondary outcomes
Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)
Time frame: 1 year
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
Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
- Background: PubMed 20021637Ostermann 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.
- Background: PubMed 19883529Friedel 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.
- Background: PubMed 18955241Ziegler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Seufferlein, Prof. M.D. principal investigator
University Clinic Halle (Saale)
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by IFAG AG at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard M Stauder, PhD (+49 (8171) 96269, stauder@ifag.biz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival time (DFS). (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448655, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.