Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-01-13 @ 8:17 AM
Study NCT ID:
NCT07274800
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2025-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Ultra-Hypofractionated vs Hypofractionated Radiotherapy for Early Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2025-11-28', 'studyFirstSubmitQcDate': '2025-11-28', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Skin Toxicity (CTCAE v5.0)', 'timeFrame': 'From start of radiotherapy to 6 weeks post-treatment', 'description': 'Incidence and severity of acute skin toxicity (erythema, desquamation, edema) assessed'}], 'secondaryOutcomes': [{'measure': 'Late Skin Toxicity and Cosmesis', 'timeFrame': '12 months post-radiotherapy', 'description': 'Incidence of late skin changes (pigmentation, fibrosis) and cosmetic outcomes assessed at 12 months post-radiotherapy using physician assessment and patient-reported outcomes (EORTC QLQ)'}, {'measure': 'Locoregional Recurrence', 'timeFrame': 'Up to 24 months post-radiotherapy', 'description': 'Rate of locoregional recurrence in the irradiated breast assessed by clinical examination and imaging at follow-up visits'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'breast-conserving surgery. One group receives ultra-hypofractionated radiotherapy (26 Gy in 5 sessions over 1 week), while the other group receives hypofractionated radiotherapy (40 Gy in 15 sessions over 3 weeks). The study aims to compare skin toxicity, cosmetic outcomes, and local cancer control between thetwo schedules . Participants are followed during and after radiotherapy for up to 24 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:• Histological diagnosis of breast adenocarcinoma\n\n* Prior breast conservative surgery negative resection margins (3 mm)\n* Pathological stage pT1-pT2, N0-1, pT3-N0, M0\n* No macroscopic evidence of distant metastases at diagnosis\n* Age 18-80 years\n* Female patients\n* Normal hematological and biochemical laboratory tests\n* Written informed consent was obtained from all patients\n\nExclusion Criteria: • Patients underwent mastectomy.\n\n* Locally advanced disease pT4, N2,3.\n* Positive surgical margins\n* Prior thoracic radiation\n* Synchronous second primary tumor\n* Distant metastases\n* Pregnancy\n* Presence of a concomitant psychiatric disorder precluding an aware informed consent.\n* Age \\>80 years\n* Low risk patient meeting all the following criteria (more than or equal 65 years, PT1, grade 1 or 2, +ER, -Her2nu, N0, M0).'}, 'identificationModule': {'nctId': 'NCT07274800', 'acronym': 'UHF vs HF-EBC', 'briefTitle': 'Adjuvant Ultra-Hypofractionated vs Hypofractionated Radiotherapy for Early Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Adjuvant Ultra Hypofractionation Radiotherapy Versus Hypofractionation Radiotherapy in Treatment of Early Invasive Breast Cancer', 'orgStudyIdInfo': {'id': '11119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A:Adjuvat Ultra-Hypofractionation Radiotherapy', 'description': 'Adjuvant external beam radiotherapy after breast-conserving surgery Total dose: 26 Gy delivered in 5 fractions over 1 week 3D conformal radiotherapy technique without breath-hold Daily fractionation, whole breast irradiation', 'interventionNames': ['Radiation: Adjuvant Ultra hypofractionation radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Adjuvant hypofractionation radiotherapy', 'interventionNames': ['Radiation: Adjuvant Hypofarctionated radiotherapy']}], 'interventions': [{'name': 'Adjuvant Ultra hypofractionation radiotherapy', 'type': 'RADIATION', 'description': 'Adjuvant external beam radiotherapy after breast-conserving surgery Total dose: 26 Gy delivered in 5 fractions over 1 week 3D conformal radiotherapy technique without breath-hold Daily fractionation, whole breast irradiation', 'armGroupLabels': ['Arm A:Adjuvat Ultra-Hypofractionation Radiotherapy']}, {'name': 'Adjuvant Hypofarctionated radiotherapy', 'type': 'RADIATION', 'description': 'Adjuvant external beam radiotherapy after breast-conserving surgery Total dose: 40 Gy delivered in 15 fractions over 3 week 3D conformal radiotherapy technique without breath-hold Daily fractionation, whole breast irradiation', 'armGroupLabels': ['Arm B: Adjuvant hypofractionation radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}