Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT01448668
Status:
UNKNOWN
Last Update Posted:
2013-07-02
First Post:
2011-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-01', 'studyFirstSubmitDate': '2011-03-30', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival time (OS).', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)', 'timeFrame': '1 year', 'description': 'As key symptom, the fatigue syndrome will be evaluated separately.'}, {'measure': 'Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score', 'timeFrame': '1 year'}, {'measure': 'Safety of Iscador® Qu (number of patients with systemic or local AE to Iscador® Qu)', 'timeFrame': '3 years'}, {'measure': 'Number of patients with adverse events (AE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pancreatic cancer', 'mistletoe', 'supportive treatment', 'long-term study', 'non-interventional cohort study', 'controlled study with parallel groups'], 'conditions': ['Pancreas Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPrimary 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.\n\nProspective observational confirmation study of previous retrospective cohort study.\n\nAs 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.', 'detailedDescription': 'see summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients visiting the center with pancreatic cancer stage UICC II-IV and meeting the eligibility criteria will be asked to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of pancreatic cancer, adenocarcinoma, UICC stage II-IV\n* Age between 18 (Austria: 19) and 85 years\n* No previous malign tumor\n* ECOG 0-2\n* Estimated life expectancy \\> 3 months\n* Surgical resection of the tumor (R0, R1) or determination of interoperability\n* Conventional oncological therapy and measurements, or passive after-care ("best care")\n* Follow-up for several years feasible\n* Patient gives written consent to use the anonymized date for evaluation\n\nExclusion Criteria:\n\n* Other Iscador® sorts than Qu in the test group\n* Other mistletoe preparations in the test group\n* Any mistletoe preparation in the control group\n* 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\n* HIV infection, Aids, organ transplantation\n* 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)\n* Patients participating in another clinical study with non-approved substances'}, 'identificationModule': {'nctId': 'NCT01448668', 'briefTitle': 'Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'IFAG AG'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ISC-4.1.6'}, 'secondaryIdInfos': [{'id': '2010-018683-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Test group with Iscador® Qu', 'description': '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).'}, {'label': 'Control group', 'description': 'The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': '5th Med., Clinic Hietzing', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Augusta Clinic', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Fulda', 'country': 'Germany', 'facility': 'MVZ Fulda', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'University Clinic - Internal Med. I', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Herdecke', 'country': 'Germany', 'facility': 'Hospital Herdecke', 'geoPoint': {'lat': 51.39999, 'lon': 7.43584}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Med. Clinic III, University Munich Grosshadern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Soest', 'country': 'Germany', 'facility': 'Clinic Kloster Paradiese', 'geoPoint': {'lat': 51.57558, 'lon': 8.10619}}, {'city': 'Ulm', 'country': 'Germany', 'facility': 'University Clinic Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Volker Heinemann, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Med. Clinic III, University Clinic Munich Grosshadern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IFAG AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hiscia Society for Cancer Research', 'class': 'UNKNOWN'}, {'name': 'IFAG Basel AG, both Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}