Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT02509234
Status:
UNKNOWN
Last Update Posted:
2015-07-27
First Post:
2015-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trabectedin and Irinotecan for Refractory Pediatric Sarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012512', 'term': 'Sarcoma, Ewing'}, {'id': 'D012208', 'term': 'Rhabdomyosarcoma'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-24', 'studyFirstSubmitDate': '2015-07-01', 'studyFirstSubmitQcDate': '2015-07-24', 'lastUpdatePostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival in comparison to matched controls.', 'timeFrame': '12 months', 'description': 'Comparison of overall survival in a matched pair analysis.'}, {'measure': 'Differences in response rate comparing response rate in Ewing Sarcoma to response rate in Soft Tissue Sarcoma', 'timeFrame': '12 months', 'description': 'Statistical comparison of response rate according to RECIST in Ewing Sarcoma vs. Soft Tissue Sarcoma'}, {'measure': 'Event free survival in comparison to matched controls.', 'timeFrame': '12 months', 'description': 'Comparison of event free survival in a matched pair analysis.'}], 'primaryOutcomes': [{'measure': 'Toxicity during therapy', 'timeFrame': 'As long as patient is undergoing therapy/ 6 months', 'description': 'WHO toxicity grading'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '12 months', 'description': 'Assessment of quality of life at the day before starting the next cycle and at months 3, 6, 9 and 12 after start of treatment, using adapted Karnofsky Score.'}, {'measure': 'Assessment of therapeutic effect', 'timeFrame': '12 months', 'description': 'Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.'}, {'measure': 'Assessment of time to treatment failure', 'timeFrame': '12 months', 'description': 'Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric sarcomas', 'Ewing sarcoma', 'rhabdomyosarcoma', 'soft tissue sarcoma'], 'conditions': ['Recurrent Childhood Soft Tissue Sarcoma', 'Recurrent Ewing Sarcoma', 'Recurrent Rhabdomyosarcoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma, for which there are presently no further treatment options in EURO-Ewing/ EURAMOS/CWS (i.e. ≥ second relapse in ES, resistance to surgery in osteosarcoma, relapsed rhabdomyosarcoma) and have been treated with a combined chemotherapy of trabectedin and irinotecan (described in intervention)\n* existing matched control in existing study databases\n* have started of treatment within three months of last progress\n\nKey Exclusion Criteria:\n\n* Patients newly diagnosed or in first relapse.'}, 'identificationModule': {'nctId': 'NCT02509234', 'acronym': 'TrIPReSarc', 'briefTitle': 'Trabectedin and Irinotecan for Refractory Pediatric Sarcomas', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Trabectedin and Irinotecan in Pediatric Refractory Sarcomas', 'orgStudyIdInfo': {'id': 'TrI.PReSarc V150429'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Combined chemotherapy with trabectedin followed by irinotecan', 'type': 'DRUG', 'description': 'Day 1:\n\nTrabectedin 1,1 - 1,5 mg/m²/day i.v.\n\nDay 3-5 and 10-12:\n\nIrinotecan 30- 90 mg/m²/day p.o. or i.v.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stefan Burdach, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Kinderklinik München Schwabing - Klinik und Poliklinik für Kinder- und Jugendmedizin, Klinikum Schwabing, Städtisches Klinikum München GmbH und Klinikum Rechts der Isar (AöR) der Technischen Universität München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}