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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 220
- Locations
- 9
- Primary Endpoint
- Overall survival time (OS).
Study Overview
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.
Detailed Description
see summary
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of pancreatic cancer, adenocarcinoma, UICC stage II-IV
- •Age between 18 (Austria: 19) and 85 years
- •No previous malign tumor
- •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
Outcomes
Primary Outcomes
Overall survival time (OS).
Time Frame: 3 years
Secondary Outcomes
- Number of patients with adverse events (AE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).(1 year)
- 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)