Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT06335251
Status:
RECRUITING
Last Update Posted:
2025-08-28
First Post:
2024-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiotherapy Treatments for Neoplasms of the Limbs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Number of patients death'}, {'measure': 'Disease free survival', 'timeFrame': '5 years', 'description': 'Number of oncological event (local recurrence, distant metastasis, other primary tumor)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Neoplasms', 'Bone Metastases']}, 'descriptionModule': {'briefSummary': 'In this observational study patients treated at European Institute of Oncology with radiotherapy to limbs will be included', 'detailedDescription': 'Approximately 60% of patients with neoplasms receive radiotherapy as part of their oncological treatment. Various primary tumors as well as metastases of various origins can be localized in the upper or lower limbs. Patients with such neoplastic localizations will therefore receive radiotherapy treatment possibly associated with other systemic or surgical treatments.\n\nTreatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects.\n\nData collection related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. The availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies.\n\nThis project aims to collect data related to radiotherapy treatments for primary or secondary neoplasms localized in the upper or lower limbs for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time, and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated at European Institute of Oncology with radiotherapy to limbs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients treated with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the upper and lower limbs for:\n\n Primary bone tumors, Primary soft tissue tumors, Primary tumors of the cardio-circulatory system, Primary tumors of the lymphatic system, Primary tumors of the nervous system and skin, Secondary metastases from various origins localized in that district.\n2. Signed informed consent\n\nExclusion Criteria:\n\n1\\. Radiotherapy in districts other than limbs.'}, 'identificationModule': {'nctId': 'NCT06335251', 'briefTitle': 'Radiotherapy Treatments for Neoplasms of the Limbs', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Radiotherapy Treatments for Neoplasms of the Limbs', 'orgStudyIdInfo': {'id': 'IEO 0728'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radiotherapy to limbs', 'description': 'Collection of data of patients receiving RT to limbs'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Barbara Alicja Jereczek', 'role': 'CONTACT'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Barbara Alicja Jereczek', 'role': 'CONTACT', 'email': 'barbara.jereczek@ieo.it', 'phone': '+39 02 57489326'}], 'overallOfficials': [{'name': 'Barbara Alicja Jereczek', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}