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

NCT01448668 | Unknown

• 2 other identifiers: ISC-4.1.62010-018683-17
• Study Type: observational
• Target: 220
• Locations: 2 countries
• Sites: 9

Brief Summary

Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with pancreatic cancer (Union for International Cancer Control, UICC stages II-IV), in addition to 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 3 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.

Conditions

Pancreas Cancer

Keywords

pancreatic cancer; mistletoe; supportive treatment; long-term study; non-interventional cohort study; controlled study with parallel groups

Outcome Measures

Primary Outcomes (1)

• Overall survival time (OS).

  3 years

Secondary Outcomes (4)

• Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)

  1 year

• Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score

  1 year

• Safety of Iscador® Qu (number of patients with systemic or local AE to Iscador® Qu)

  3 years

• Number of patients with adverse events (AE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).

  1 year

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients visiting the center with pancreatic cancer stage UICC II-IV and meeting the eligibility criteria will be asked to participate.

You may qualify if:

• Confirmed diagnosis of pancreatic cancer, adenocarcinoma, UICC stage II-IV
• Age between 18 (Austria: 19) and 85 years
• No previous malign tumor
• ECOG 0-2
• Estimated life expectancy \> 3 months
• Surgical resection of the tumor (R0, R1) or determination of interoperability
• 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

You may not qualify if:

• 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
• 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)
• Patients participating in another clinical study with non-approved substances

Sponsors & Collaborators

• IFAG AG: lead
• Hiscia Society for Cancer Research: collaborator
• IFAG Basel AG, both Switzerland: collaborator

Study Sites (9)

5th Med., Clinic Hietzing

Vienna, Austria

Location

University Vienna

Vienna, Austria

Location

Augusta Clinic

Bochum, Germany

Location

MVZ Fulda

Fulda, Germany

Location

University Clinic - Internal Med. I

Halle, Germany

Location

Hospital Herdecke

Herdecke, Germany

Location

Med. Clinic III, University Munich Grosshadern

Munich, Germany

Location

Clinic Kloster Paradiese

Soest, Germany

Location

University Clinic Ulm

Ulm, Germany

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Volker Heinemann, Prof. MD

  Med. Clinic III, University Clinic Munich Grosshadern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: October 7, 2011
• Study Start: September 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 2, 2013

Record last verified: 2013-07

Locations

AU (2); DE (7)