Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-05 @ 5:48 AM
Study NCT ID:
NCT00130858
Status:
COMPLETED
Last Update Posted:
2009-04-02
First Post:
2005-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-01', 'studyFirstSubmitDate': '2005-08-15', 'studyFirstSubmitQcDate': '2005-08-15', 'lastUpdatePostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response according to RECIST criteria'}], 'secondaryOutcomes': [{'measure': 'Toxicity'}, {'measure': 'Overall-Survival'}, {'measure': 'Event-free-survival'}]}, 'conditionsModule': {'keywords': ['Sarcoma, Soft Tissue'], 'conditions': ['Sarcoma, Soft Tissue']}, 'descriptionModule': {'briefSummary': 'Phase II Study to evaluate the response on two blocks of topotecan and carboplatin', 'detailedDescription': 'Phase II study for patients with chemosensible soft tissue sarcoma stage IV in children and adolescents ; response according to RECIST criteria following two blocks of combination therapy consisting of Topotecan and carboplatin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Soft tissue sarcoma chemosensible, stage IV\n* age \\< 21\n* measurable tumor lesions\n\nExclusion Criteria:\n\n* Lack of cooperation by the patient\n* no willingness of follow-up examinations\n* participation on another clinical trial at the same time\n* death due to the sickness within four weeks'}, 'identificationModule': {'nctId': 'NCT00130858', 'briefTitle': 'a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4', 'organization': {'class': 'OTHER', 'fullName': 'Cooperative Weichteilsarkom Study Group'}, 'officialTitle': 'a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4', 'orgStudyIdInfo': {'id': 'CWS-IV 2002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Topotecan', 'type': 'DRUG'}, {'name': 'Carboplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99089', 'city': 'Erfurt', 'state': 'Saxony', 'country': 'Germany', 'facility': 'HELIOS Klinikum Erfurt GmbH'}, {'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Zentralklinikum', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klinikum Berlin-Buch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Virchow Klinik', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53113', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Zentrum für Kinderheilkunde', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '28205', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Zentralkrankenhaus Bremen', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '50735', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Klinikum der Stadt Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '50931', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitäts-Kinderklinik', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinik der technischen Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40001', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Heinrich-Heine-Universität', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinik für Kinderund Jugendliche', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum der Universität', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitäts-Kinderklinik Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Klinikum der Justus-Liebig-Universität', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Georg-August-Universität', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '20251', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitäts-Kinderklinik Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Kinderklinik der Medizinischen Hochschule', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69112', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitäts-Kinderklinik', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '66421', 'city': 'Homburg/saar', 'country': 'Germany', 'facility': 'Universitäts-Kinderklinik'}, {'zip': '07740', 'city': 'Jena', 'country': 'Germany', 'facility': 'Klinik für Kinder- und Jugendmedizin', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '76131', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Städtisches Klinikum Karlruhe', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Klinikum der Universität Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '04137', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinik und Poliklinik', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '67067', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Kinderklinik St. Annastift', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '25538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Medizinische Universität zu Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Medizinische Fakultät', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '55101', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Klinikum der Johannes-Gutenberg-Universität', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '80337', 'city': 'München', 'country': 'Germany', 'facility': 'Dr. von Haunersches Kinderspital', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '80804', 'city': 'München', 'country': 'Germany', 'facility': 'Städtisches Krankenhaus Technische Universität Schwabing', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Westfälische Wilhelms-Universität', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '90419', 'city': 'Nuremberg', 'country': 'Germany', 'facility': "Cnopf'sche Kinderklinik", 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '93049', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Klinik St. Hedwig', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '53757', 'city': 'Sankt Augustin', 'country': 'Germany', 'facility': 'Johanniter-Kinderklinik', 'geoPoint': {'lat': 50.77538, 'lon': 7.197}}, {'zip': '70176', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Olgahospital', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitäts-Kinderklinik', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '89075', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitäts-Kinderklinik', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitäts-Kinderklinik', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Thomas Klingebiel, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinikum der Johann Wolfgang Goethe-Universität'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cooperative Weichteilsarkom Study Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsche Krebshilfe e.V., Bonn (Germany)', 'class': 'OTHER'}]}}}