Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-03 @ 8:21 PM
Study NCT ID:
NCT04535895
Status:
WITHDRAWN
Last Update Posted:
2022-10-12
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], '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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Treatment standard has changed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Radiation induced toxicity (grade 2 or higher)', 'timeFrame': 'Measurement at the last 1 day of radiotherapy', 'description': 'Toxicity score using Common Terminology for Adverse Events (CTCAE)'}, {'measure': 'Acute Radiation induced toxicity (grade 2 or higher)', 'timeFrame': 'Measurement 3 months after completion of radiotherapy', 'description': 'Toxicity score using Common Terminology for Adverse Events (CTCAE)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Radiotherapy Side Effect']}, 'referencesModule': {'references': [{'pmid': '22280808', 'type': 'BACKGROUND', 'citation': 'Hurkmans CW, Dijckmans I, Reijnen M, van der Leer J, van Vliet-Vroegindeweij C, van der Sangen M. Adaptive radiation therapy for breast IMRT-simultaneously integrated boost: three-year clinical experience. Radiother Oncol. 2012 May;103(2):183-7. doi: 10.1016/j.radonc.2011.12.014. Epub 2012 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer.\n\nSimultaneous integrated boost (SIB) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, SIB enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques.\n\nThe proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using SIB technique.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive breast cancer or ductal carcinoma in situ\n* Breast conserving surgery\n* Complete tumor resection\n* Treatment with adjuvant radiotherapy of the breast\n* Indication for boost Irradiation\n* Given informed consent\n\nExclusion Criteria:\n\n* Incomplete tumor resection\n* Mastectomy\n* Distant metastases at diagnosis\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT04535895', 'briefTitle': 'Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Simultaneous Integrated Boost (SIB) Technique in the Adjuvant Radiotherapy of Breast Cancer Patients.', 'orgStudyIdInfo': {'id': '1094/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simultaneous integrated boost arm', 'interventionNames': ['Radiation: Simultaneous integrated boost']}], 'interventions': [{'name': 'Simultaneous integrated boost', 'type': 'RADIATION', 'description': 'Adjuvant breast cancer irradiation including simultaneous integrated boost', 'armGroupLabels': ['Simultaneous integrated boost arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Tanja Langsenlehner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz, Dept. of Therapeutic Radiology and Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}