Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT01614002
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2012-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Non Interventional Study With Doce Onkovis (Docetaxel) Utilized for the Treatment of Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 371}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2012-06-01', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the quantity of Doce onkovis needed pro treatment cycle', 'timeFrame': 'the time the participants will be followed depends on the number of treatment cycles; that means the time frame may extend up to 24 weeks (8 cycles).', 'description': 'Determine the quantity of Doce onkovis needed pro treatment cycle'}], 'secondaryOutcomes': [{'measure': 'adverse events during and after treatment', 'timeFrame': 'up to 24 weeks (8 cycles)', 'description': 'The number and kind of adverse events during and after the intra-venous application of Docetaxel will be assessed and documented.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['carcinoma', 'breast cancer', 'non-small cell lung cancer', 'prostata cancer', 'adenocarcinoma of the stomach', 'squamous cell carcinoma of the head and neck region', 'ambulant chemotherapy', 'treatment cycles', 'Docetaxel', 'Doce onkovis', 'Quantity of Docetaxel', 'Packaging Sizes'], 'conditions': ['Carcinoma']}, 'descriptionModule': {'briefSummary': 'The main purpose of this observational study with Docetaxel is to determine the number of treatment cycles and the quantity of Doce onkovis needed therefore under the special circumstance of ambulant chemotherapy.\n\nonkovis aims an economical utilization of the chemotherapeutics.The provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective.\n\nSecondary objectives are the evaluation of the safety and tolerability of Doce onkovis. To this purpose data regarding co medications and adverse events are also collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated in practices, clinics, hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for Docetaxel according to the SmPC and treating physician\n\nExclusion Criteria:\n\n* according to the Docetaxel SmPC'}, 'identificationModule': {'nctId': 'NCT01614002', 'briefTitle': 'A Non Interventional Study With Doce Onkovis (Docetaxel) Utilized for the Treatment of Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Onkovis GmbH'}, 'officialTitle': 'Open, Multicenter Observational Study of Docetaxel Utilized in Mono- or Combination Therapy for Treatment of Breast Cancer, NSCLC, Prostate Carcinoma, Adenocarcinoma of Stomach and Advanced Squamous Cell Carcinoma of Head/Neck Region.', 'orgStudyIdInfo': {'id': 'ONKODOC 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'carcinoma, Doce onkovis (Docetaxel)', 'description': 'treatment in mono- or combination therapy with Docetaxel of breast cancer, non-small cell lung cancer, prostata carcinoma, adenocarcinoma of the stomach and advanced squamous cell carcinoma of the head/neck region.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13156', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14770', 'city': 'Brandenburg', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 52.41667, 'lon': 12.55}}, {'zip': '09117', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '03055', 'city': 'Cottbus', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 51.75769, 'lon': 14.32888}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01920', 'city': 'Elstra', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 51.22172, 'lon': 14.13201}}, {'zip': '01705', 'city': 'Freital', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 51.00166, 'lon': 13.6488}}, {'zip': '15517', 'city': 'Fürstenwalde', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 52.36067, 'lon': 14.06185}}, {'zip': '06132', 'city': 'Halle', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '06366', 'city': 'Köthen', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 51.75185, 'lon': 11.97093}}, {'zip': '96317', 'city': 'Kronach', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 50.23963, 'lon': 11.33308}}, {'zip': '04277', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Hospital', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04277', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '39104', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '98617', 'city': 'Meiningen', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 50.56787, 'lon': 10.41521}}, {'zip': '99974', 'city': 'Mühlhausen', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 51.20896, 'lon': 10.45275}}, {'zip': '19370', 'city': 'Parchim', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 53.42631, 'lon': 11.84875}}, {'zip': '08525', 'city': 'Plauen', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 50.4973, 'lon': 12.13782}}, {'zip': '09481', 'city': 'Scheibenberg', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 50.54023, 'lon': 12.91215}}, {'zip': '04860', 'city': 'Torgau', 'country': 'Germany', 'facility': 'Clinic', 'geoPoint': {'lat': 51.56016, 'lon': 12.99617}}, {'zip': '08412', 'city': 'Werdau', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 50.73604, 'lon': 12.37534}}, {'zip': '02763', 'city': 'Zittau', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 50.89772, 'lon': 14.80764}}, {'zip': '08060', 'city': 'Zwickau', 'country': 'Germany', 'facility': 'Practice', 'geoPoint': {'lat': 50.72724, 'lon': 12.48839}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onkovis GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AKP Freiburg GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}