Status:
UNKNOWN
Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)
Lead Sponsor:
IFAG AG
Collaborating Sponsors:
Hiscia Society for Cancer Research
IFAG Basel AG, both Switzerland
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18-85 years
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, UI...
Detailed Description
see summary
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01448668
Start Date
September 1 2010
End Date
June 1 2016
Last Update
July 2 2013
Active Locations (9)
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1
5th Med., Clinic Hietzing
Vienna, Austria
2
University Vienna
Vienna, Austria
3
Augusta Clinic
Bochum, Germany
4
MVZ Fulda
Fulda, Germany