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

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ClinicalTrials.gov Identifier: NCT01448655
Recruitment Status : Unknown
Verified July 2013 by IFAG AG.
Recruitment status was:  Recruiting
First Posted : October 7, 2011
Last Update Posted : July 2, 2013
Sponsor:
Collaborators:
Hiscia Society for Cancer Research
IFAG Basel AG (CRO), both Switzerland
Information provided by (Responsible Party):
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.


Condition or disease
Colorectal Cancer

Detailed Description:
see summary

Study Type : Observational
Estimated Enrollment : 300 participants
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
Study Start Date : September 2010
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. Disease-free survival time (DFS). [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life) [ Time Frame: 1 year ]
    As key symptom, the fatigue syndrome will be evaluated separately.

  2. Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score [ Time Frame: 1 year ]
  3. Interim analysis on overall survival time (OS) in UICC stage IV patients [ Time Frame: 2 years ]
  4. Safety of Iscador® Qu (number of patients with systemic or local adverse events (AE) to Iscador® Qu) [ Time Frame: 5 years ]
    Adverse events (local and/or systemic) contributable to Iscador® Qu

  5. Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy). [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448655


Contacts
Contact: Gerhard M Stauder, PhD +49 (8171) 96269 stauder@ifag.biz

Locations
Austria
5th Med., Clinic Hietzing Recruiting
Vienna, Austria
Contact: Thomas Stein, MD         
University Vienna Recruiting
Vienna, Austria
Contact: Leo Auerbach, Prof. 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)

Publications:
Responsible Party: IFAG AG
ClinicalTrials.gov Identifier: NCT01448655     History of Changes
Other Study ID Numbers: ISC-4.1.5
2010-018682-31 ( EudraCT Number )
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013

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:
Viscum album peptide
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents