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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 Pancreatic Cancer Stages UICC II-IV


N/A
18 Years
85 Years
Open (Enrolling)
Both
Pancreas Cancer

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Trial Information

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 Pancreatic Cancer Stages UICC II-IV


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Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Overall survival time (OS).

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Volker Heinemann, Prof. MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Med. Clinic III, University Clinic Munich Grosshadern

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

ISC-4.1.6

NCT ID:

NCT01448668

Start Date:

September 2010

Completion Date:

June 2016

Related Keywords:

  • Pancreas Cancer
  • pancreatic cancer
  • mistletoe
  • supportive treatment
  • long-term study
  • non-interventional cohort study
  • controlled study with parallel groups
  • Pancreatic Neoplasms

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