Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-01 @ 5:11 PM
Study NCT ID:
NCT04699292
Status:
RECRUITING
Last Update Posted:
2022-08-30
First Post:
2021-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International Prospective Registry on Local Treatment Approaches in MLS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018208', 'term': 'Liposarcoma, Myxoid'}], 'ancestors': [{'id': 'D008080', 'term': 'Liposarcoma'}, {'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2031-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient-Reported Outcome Measures (PROMs)', 'timeFrame': 'From baseline visit to the end of 5 years of follow-up', 'description': 'PRO-CTCAE Item Library; relevant questions from the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE)'}, {'measure': 'Health-Related Quality of Life (HRQoL)', 'timeFrame': 'From baseline visit to the end of 5 years of follow-up', 'description': 'EORTC QLQ-C30; 30-item HRQoL questionnaire; EORTC Items Library; 3 questions to assess some radiotherapy-specific HRQoL; EQ5D-5L; descriptive system for measurement of health; iMCQ; relevant items from the Medical Consumption Questionnaire (iMCQ) to assess medical consumption; PRODISQ; PROductivity and DISease Questionnaire to assess all relevant aspects of the relationship between health and productivity;'}], 'primaryOutcomes': [{'measure': 'Local recurrence free survival', 'timeFrame': 'From surgery to the end of at least 5 years of follow-up', 'description': 'Survival from surgery to local recurrence (event) or last follow-up'}], 'secondaryOutcomes': [{'measure': 'Wound complications', 'timeFrame': 'From surgery to 6 months of follow-up', 'description': 'Any wound complication requiring intervention'}, {'measure': 'Late toxicity', 'timeFrame': 'From 3 months after surgery to the end of at least 5 years of follow-up', 'description': 'Any grade ≥2 late (radiation-induced) toxicity according to CTCAE v5.0 toxicity criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myxoid Liposarcoma']}, 'descriptionModule': {'briefSummary': 'To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)', 'detailedDescription': 'In order to confirm the promising results of the 36 Gy dose level in the DOREMY trial (NCT02106312) and to compare outcome with other local treatment approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with Myxoid Liposarcoma (MLS) that will be treated in one of the participating Sarcoma Reference Centers according to one of the treatment approaches defined in the 5 cohorts.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Biopsy proven MLS, including the reciprocal chromosomal translocation t(12;16)(q13;p11)\n* ECOG PS 0-2\n* Written informed consent to share coded information in this international Registry\n\nExclusion Criteria:\n\n* Prior radiotherapy to the target area\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04699292', 'briefTitle': 'International Prospective Registry on Local Treatment Approaches in MLS', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'International Prospective Registry on Local Treatment Approaches in Myxoid Liposarcomas', 'orgStudyIdInfo': {'id': 'M20DMY'}, 'secondaryIdInfos': [{'id': 'IRBd20-354', 'type': 'OTHER', 'domain': 'The Netherlands Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'MLS patients managed by surgery only', 'interventionNames': ['Procedure: Surgery']}, {'label': 'Cohort B', 'description': 'MLS patients receiving preoperative RT to a dose of 36 Gy (equivalent) followed by surgery', 'interventionNames': ['Procedure: Surgery', 'Radiation: Preoperative RT 36Gy']}, {'label': 'Cohort C', 'description': 'MLS patients receiving preoperative RT to a dose of 50 Gy (equivalent) followed by surgery', 'interventionNames': ['Procedure: Surgery', 'Radiation: Preoperative RT 50Gy']}, {'label': 'Cohort D', 'description': 'MLS patients receiving surgery followed by postoperative RT to a dose of 50-66 Gy (equivalent)', 'interventionNames': ['Procedure: Surgery', 'Radiation: Postoperative RT 50-66Gy']}, {'label': 'Cohort E', 'description': 'MLS patients with oligometastatic and/or oligoprogressive disease receiving definitive RT to a dose of 36Gy (equivalent)', 'interventionNames': ['Radiation: RT 36Gy']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Surgery', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C', 'Cohort D']}, {'name': 'Preoperative RT 36Gy', 'type': 'RADIATION', 'description': 'Preoperative radiotherapy to 36Gy (equivalent)', 'armGroupLabels': ['Cohort B']}, {'name': 'Preoperative RT 50Gy', 'type': 'RADIATION', 'description': 'Preoperative radiotherapy to 50Gy (equivalent)', 'armGroupLabels': ['Cohort C']}, {'name': 'Postoperative RT 50-66Gy', 'type': 'RADIATION', 'description': 'Postoperative radiotherapy to 50-66Gy (equivalent)', 'armGroupLabels': ['Cohort D']}, {'name': 'RT 36Gy', 'type': 'RADIATION', 'description': 'Definitive radiotherapy to 36Gy (equivalent)', 'armGroupLabels': ['Cohort E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066CX', 'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rick Haas, MD/PhD', 'role': 'CONTACT'}, {'name': 'Jules Lansu, MD/PhD', 'role': 'CONTACT'}], 'facility': 'The Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Rick Haas, MD/PhD', 'role': 'CONTACT', 'email': 'r.haas@nki.nl', 'phone': '+31 20 512 9111'}, {'name': 'Jules Lansu, MD/PhD', 'role': 'CONTACT', 'email': 'j.lansu@nki.nl', 'phone': '+31 20 512 9111'}], 'overallOfficials': [{'name': 'Rick Haas, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Netherlands Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radboud University Medical Center', 'class': 'OTHER'}, {'name': 'Maastro Clinic, The Netherlands', 'class': 'OTHER'}, {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, {'name': 'Vienna General Hospital', 'class': 'OTHER'}, {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, {'name': 'Universitetssykehus', 'class': 'UNKNOWN'}, {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'Universitäts-Frauenklinik Graz', 'class': 'OTHER'}, {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'National Cancer Center, Japan', 'class': 'OTHER_GOV'}, {'name': 'Princess Margaret Hospital, Canada', 'class': 'OTHER'}, {'name': 'MOUNT SINAI HOSPITAL', 'class': 'OTHER'}, {'name': 'University of Sydney', 'class': 'OTHER'}, {'name': 'Institute for Cancer Research and treatment', 'class': 'UNKNOWN'}, {'name': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'class': 'OTHER'}, {'name': 'Institut Curie', 'class': 'OTHER'}, {'name': 'Australia and New Zealand Sarcoma Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}