Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT06050434
Status:
TERMINATED
Last Update Posted:
2025-12-01
First Post:
2023-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'The study was terminated prematurely due to slow recruitment after inclusion of 7 patients (of initially planned 100 patients).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2023-09-15', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of PRO data capture via an electronic tool (ePRO)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Assessment of PRO data capture via an electronic tool (ePRO), e.g. handling, user experience, completion rate, adherence) and its implementation into the routine sarcoma patient care (parameters will e.g. include patient acceptance, represented by the rate of patients entering an ePRO tool at least once) for sarcoma patients under Trabectedin rechallenge'}], 'primaryOutcomes': [{'measure': 'Patient reported outcome regarding symptoms and side effects during Trabectedin re-challenge in soft tissue sarcoma patients', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'PRO-CTCAE questionnaire'}, {'measure': 'Patient reported outcome regarding distress during Trabectedin re-challenge in soft tissue sarcoma patients', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Distress-Thermometer'}, {'measure': 'Patient reported outcome regarding quality of life during Trabectedin re-challenge in soft tissue sarcoma patients', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'QLQ-C30 Questionnaire'}, {'measure': 'Patient reported outcome regarding cancer behaviour inventory', 'timeFrame': 'every nine to 18 weeks during Trabectedin re-challenge, every 3 Month in follow up', 'description': 'CBI-B Questionnaire'}, {'measure': 'Patient reported outcome measuring anxiety and depression', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'PHQ-4 Questionnaire'}, {'measure': 'Patient reported outcome measuring self-efficacy for managing chronic disease', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'SES6G Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Analysis of correlation of PROs with clinical parameters', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Evaluation of different PROs and analysis of correlation with clinical parameters, e.g. therapy response and side effects experienced during therapy'}, {'measure': 'Characterization of patients receiving Trabectedin rechallenge in real life setting', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Characterization of patients receiving Trabectedin rechallenge in real life setting, e.g. demographics, previous therapies'}, {'measure': 'Characterization of Trabectedin rechallenge in real life conditions', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Characterization of Trabectedin rechallenge in real life conditions, e.g. number of Trabectedin cycles applied, response to therapy, reason for end of Trabectedin rechallenge (e.g. disease progression, intolerable toxicity, death)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Re-Challenge', 'Trabectedin', 'Sarcoma', 'registry', 'PRO'], 'conditions': ['Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': 'Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. The prospective study will primarily investigate the PRO of Trabectedin rechallenge in patients with soft tissue sarcomas that had to discontinue initial Trabectedin treatment due to various reasons such as progression, side effects or surgery, as is commonly the case in real-life settings. Embedding this trial in the GISAR registry enables the evaluation of a large number of patients with long-term follow-up which allows multiple analyses regarding different questions that remain unanswered until today.', 'detailedDescription': 'Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. Several features differentiate its clinical performance from other chemotherapeutic agents, including durability of response and the absence of cumulative toxicity even upon re-exposition to treatment after interruption of therapy. In addition, the results of the T-Dis trial evaluating the impact of Trabectedin rechallenge demonstrated that it retains its activity when patients are rechallenged on progression after a treatment break.\n\nSince sarcoma patient usually report a worse global quality of life (QoL) compared to the general population, one of the main goals of treating advanced-stage patients with Trabectedin, in addition to its efficacy, is to improve the QoL, represented by symptom control and other patient-related outcomes. However, little is known to date about the QoL during a rechallenge with Trabectedin, after patients had to discontinue Trabectedin treatment.\n\nPatient-reported outcome (PRO) measures are standardized questionnaires that collect information on health outcomes directly from the patients, including symptoms, health-related QoL parameters and functional status. In general, there are two types of PROMs, disease-specific and general measures that can also be used for healthy populations. A growing number of articles supports the need for, as well as the benefit of, deriving information directly from patients. Thus, the application of PRO measures, initially developed for the use in research, has become more common nowadays and their application is included in supporting clinical decision making, comparing outcomes among health-care providers, stimulating quality improvement and evaluating practices and policies. Therefore, the collection of real-world data from patients subject to Trabectedin rechallenge would enable further estimations on the feasibility and efficacy of Trabectedin rechallenge.\n\nThe prospective PROTraSarc sub-study will primarily investigate the PRO of Trabectedin rechallenge in patients with soft tissue sarcomas that had to discontinue initial Trabectedin treatment due to various reasons such as progression, side effects or surgery, as is commonly the case in real-life settings. Embedding this trial in the GISAR registry enables the evaluation of a large number of patients with long-term follow-up which allows multiple analyses regarding different questions that remain unanswered until today.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult GISAR participants with Trabectedin-pretreated soft tissue sarcomas and rechallenge with at least one cycle of Trabectedin in any line of therapy, with the interval between Trabectedin interruption and Trabectedin rechallenge being at least 3 months.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled participant of the GISAR registry and their sub-studies\n* Patient with histologically confirmed soft tissue sarcomas\n* Pretreatment with Trabectedin, termination of this therapy regardless of reason\n* Planned rechallenge or started rechallenge with Trabectedin in any line of therapy within 2 weeks before inclusion\n* Interval between last Trabectedin treatment and Trabectedin rechallenge at least 3 months\n\nExclusion Criteria:\n\n* Not able to understand all implications of study participation\n* No written informed consent\n* Age ≤ 18 years'}, 'identificationModule': {'nctId': 'NCT06050434', 'acronym': 'PROTraSarc', 'briefTitle': 'Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest'}, 'officialTitle': 'PROTraSarc Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients - A GISAR Sub-study', 'orgStudyIdInfo': {'id': 'PROTraSarc'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trabectedin Rechallenge in Soft sarcoma patients', 'description': 'Adult GISAR participants with Trabectedin-pretreated soft tissue sarcomas and rechallenge with at least one cycle of Trabectedin in any line of therapy, with the interval between Trabectedin interruption and Trabectedin rechallenge being at least 3 months.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Saarow', 'country': 'Germany', 'facility': 'HELIOS KLinikum Bad Saarow', 'geoPoint': {'lat': 52.28333, 'lon': 14.06667}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'HELIOS Klinikum Berlin Buch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Frankfurt Universitätsklinikum', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'Universitätsmedizin Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Greifswald', 'country': 'Germany', 'facility': 'Universitätsmedizin Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Uniklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Westfälische Wilhelms-Universität Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Markus Schuler, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Onkologischer Schwerpunkt Oskar-Helene-Heim, Clinic and Polyclinic for Internal Medicine I, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany'}, {'name': 'Daniel Pink, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sarcoma Center Berlin-Brandenburg, Helios Hospital Bad Saarow, Department of Internal Medicine C, University Hospital Greifswald, Germany'}, {'name': 'Salah-Eddin Al-Batran, Prof. Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut für Klinische Krebsforschung am Krankenhaus Nordwest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest', 'class': 'OTHER'}, 'collaborators': [{'name': 'PharmaMar', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}