Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:40 PM
Study NCT ID:
NCT07407192
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toxicity Outcomes of Simultaneous Integrated Boost in Adjuvant Breast Radiotherapy Acronym
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with breast cancer after breast-conserving surgery receive adjuvant radiotherapy with a simultaneous integrated boost (SIB) to the tumor bed. Acute and late toxicity outcomes are prospectively recorded.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Radiation Toxicity (CTCAE)', 'timeFrame': 'From start of radiotherapy up to 3 months after completion of radiotherapy', 'description': 'Incidence and severity of acute radiotherapy-related toxicity assessed during treatment and shortly after completion, graded according to Common Terminology Criteria for Adverse Events (CTCAE).'}, {'measure': 'Acute Radiation Toxicity (CTCAE)', 'timeFrame': 'From start of radiotherapy up to 3 months after completion of radiotherapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This prospective study systematically evaluates toxicity outcomes in breast cancer patients treated with adjuvant radiotherapy using the simultaneous integrated boost (SIB) technique after breast-conserving surgery. The aim is to monitor acute and late treatment-related side effects during implementation of this radiotherapy approach and to compare institutional toxicity outcomes with published data in the literature.', 'detailedDescription': 'Breast cancer patients undergoing breast-conserving surgery are treated with adjuvant radiotherapy using either standard fractionation or hypofractionation combined with a simultaneous integrated boost (SIB) to the tumor bed. This prospective study includes systematic collection and grading of acute and late radiation-related toxicity outcomes in order to evaluate the safety of the implemented protocol and to assess whether toxicity rates are comparable to those reported in published clinical studies. The results will support optimization and quality assurance of the radiotherapy technique in routine clinical practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with histologically confirmed breast cancer\n* Status post breast-conserving surgery (lumpectomy)\n* Planned adjuvant whole-breast radiotherapy with simultaneous integrated boost (SIB) to the tumor bed\n* Age ≥ 18 years\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to the breast or thoracic region\n* Mastectomy (no breast-conserving surgery)\n* Pregnancy or breastfeeding\n* Inability to complete planned radiotherapy or follow-up assessments'}, 'identificationModule': {'nctId': 'NCT07407192', 'acronym': 'SIB', 'briefTitle': 'Toxicity Outcomes of Simultaneous Integrated Boost in Adjuvant Breast Radiotherapy Acronym', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Oncology Ljubljana'}, 'officialTitle': 'Toxicity Outcomes of Simultaneous Integrated Boost as Part of Adjuvant Radiotherapy in Breast Cancer Patients After Breast-Conserving Surgery', 'orgStudyIdInfo': {'id': 'OI-BREAST-SIB-2019'}, 'secondaryIdInfos': [{'id': 'ERIDEK-0045/2019', 'type': 'OTHER', 'domain': 'Ethics Committee, Institute of Oncology Ljubljana'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adjuvant Radiotherapy With Simultaneous Integrated Boost (SIB)', 'description': 'Breast cancer patients treated with breast-conserving surgery receive adjuvant radiotherapy to the whole breast with a simultaneous integrated boost (SIB) to the tumor bed, using either standard fractionation or hypofractionation. Acute and late toxicity outcomes are prospectively recorded.', 'interventionNames': ['Radiation: Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB)']}], 'interventions': [{'name': 'Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB)', 'type': 'RADIATION', 'description': 'Adjuvant whole-breast radiotherapy after breast-conserving surgery with a simultaneous integrated boost (SIB) dose delivered to the tumor bed during the same treatment sessions. Treatment is delivered using either standard fractionation or hypofractionation, according to institutional protocol.', 'armGroupLabels': ['Adjuvant Radiotherapy With Simultaneous Integrated Boost (SIB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Institute of Oncology Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}