Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-03-06 @ 2:53 AM
Study NCT ID:
NCT02561559
Status:
UNKNOWN
Last Update Posted:
2022-05-04
First Post:
2015-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2015-09-25', 'studyFirstSubmitQcDate': '2015-09-25', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local control of treated lesions', 'timeFrame': '12 months', 'description': 'Evaluation of proportion of patients free from progression from starting radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Overall survival of treated patients', 'timeFrame': '4 years', 'description': 'Evaluation of proportion of patients alive'}, {'measure': 'Disease free survival of treated patients', 'timeFrame': '4 years', 'description': 'Evaluation of proportion of patients alive and free from progression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastasis From Malignant Tumor of Soft Tissues']}, 'referencesModule': {'references': [{'pmid': '25686482', 'type': 'BACKGROUND', 'citation': "Navarria P, Ascolese AM, Cozzi L, Tomatis S, D'Agostino GR, De Rose F, De Sanctis R, Marrari A, Santoro A, Fogliata A, Cariboni U, Alloisio M, Quagliuolo V, Scorsetti M. Stereotactic body radiation therapy for lung metastases from soft tissue sarcoma. Eur J Cancer. 2015 Mar;51(5):668-74. doi: 10.1016/j.ejca.2015.01.061. Epub 2015 Feb 13."}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from STS.', 'detailedDescription': 'The investigators started to treat PM oligometastatic patients with Stereotactic Body Radiotherapy.\n\nThe investigators objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from soft-tissue sarcomas. Overall and disease free survival will be evaluated as secondary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by soft-tissue sarcomas with lung metastases unsuitable for surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 anni -85 years\n* PS according to ECOG 0-2\n* Histopathologically confirmation of soft tissue sarcoma\n* Metastatic lung lesion less than 4\n* Controlled primary tumor and other metastatic lesions\n* Metastatic lesion less than 5 such as the definition of oligometastatic patients\n* Written informed consent\n* Contraindication to surgical resection\n* Estimated survival ≥ 3 months\n* Absence of progressive disease longer than 6 months\n* No chemotherapy was given for at least 3 months after SBRT\n* Maximum diameter ≤ 5 cm\n\nExclusion Criteria:\n\n* Prior thorax radiation therapy\n* Age \\> 85 years\n* PS according to ECOG \\>2\n* Pregnant women\n* Maximum diameter ≥ 5.1 cm\n* Total volume of lung lesion greater than 1/3 of the whole pulmonary parenchima'}, 'identificationModule': {'nctId': 'NCT02561559', 'briefTitle': 'SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Phase II Study to Evaluate Feasibility and Safety of Stereotactic Body Radiation Radiotherapy (SBRT) for Lung Metastases From Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': '1393'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung metastasis from soft-tissue sarcoma', 'description': 'Lung metastases from soft-tissue sarcoma', 'interventionNames': ['Radiation: Lung metastasis from soft-tissue sarcoma']}], 'interventions': [{'name': 'Lung metastasis from soft-tissue sarcoma', 'type': 'RADIATION', 'description': 'Tretament based on Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT)', 'armGroupLabels': ['Lung metastasis from soft-tissue sarcoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano, MI', 'state': 'Milan', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'Marta Scorsetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Clinico Humanitas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Michele Tedeschi', 'investigatorAffiliation': 'Istituto Clinico Humanitas'}}}}