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

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

Tracking Information

• First Submitted Date: March 29, 2011
• First Posted Date: October 7, 2011
• Last Update Posted Date: July 2, 2013
• Study Start Date: September 2010
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 6, 2011): Disease-free survival time (DFS). [ Time Frame: 5 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 6, 2011)

• 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.
• 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 ]
  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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Colorectal Cancer
• Intervention: Not Provided

Study 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).

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.
• Friedel 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.
• Ziegler 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 1, 2013): 300
• Original Estimated Enrollment (submitted: October 6, 2011): 800
• Estimated Study Completion Date: June 2017
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany

Administrative Information

• NCT Number: NCT01448655
• Other Study ID Numbers: ISC-4.1.5; 2010-018682-31 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: IFAG AG
• Original Responsible Party: Same as current
• Current Study Sponsor: IFAG AG
• Original Study Sponsor: Same as current

Collaborators

• Hiscia Society for Cancer Research
• IFAG Basel AG (CRO), both Switzerland

Investigators

• Principal Investigator: Thomas Seufferlein, Prof. M.D.; University Clinic Halle (Saale)

• PRS Account: IFAG AG
• Verification Date: July 2013