Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT05591456
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2022-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018714', 'term': 'Radiotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-23', 'studyFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2022-10-19', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detection of breast shrinkage', 'timeFrame': 'three months after radiotherapy', 'description': 'breast size measured before and after radiotharapy'}, {'measure': 'detection of breast shrinkage', 'timeFrame': '6 months after radiotherapy', 'description': 'breast size measured before and after radiotharapy'}, {'measure': 'breast on the treated side is indurated', 'timeFrame': '3 months after radiotherapy', 'description': 'the induration detected by palpation with comparison with the normal side'}, {'measure': 'detection of irregularity of breast shape', 'timeFrame': '3 months after radiotherapy', 'description': 'change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy'}, {'measure': 'breast on the treated side is indurated', 'timeFrame': '6 months after radiotherapy', 'description': 'the induration detected by palpation with comparison with the normal side'}, {'measure': 'detection of irregularity of breast shape', 'timeFrame': '6 months after radiotherapy', 'description': 'change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Radiotherapy']}, 'referencesModule': {'references': [{'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}, {'pmid': '7619770', 'type': 'BACKGROUND', 'citation': 'Ash DV, Benson EA, Sainsbury JR, Round C, Head C. Seven-year follow-up on 334 patients treated by breast conserving surgery and short course radical postoperative radiotherapy: a report of the Yorkshire Breast Cancer Group. Clin Oncol (R Coll Radiol). 1995;7(2):93-6. doi: 10.1016/s0936-6555(05)80808-8.'}, {'pmid': '25328522', 'type': 'BACKGROUND', 'citation': 'Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.'}, {'pmid': '23572855', 'type': 'BACKGROUND', 'citation': 'Fajdic J, Djurovic D, Gotovac N, Hrgovic Z. Criteria and procedures for breast conserving surgery. Acta Inform Med. 2013 Mar;21(1):16-9. doi: 10.5455/AIM.2013.21.16-19.'}, {'pmid': '25458960', 'type': 'BACKGROUND', 'citation': 'Aleknavicius E, Atkocius V, Kuzmickiene I, Steponaviciene R. Postmastectomy internal mammary nodal irradiation: a long-term outcome. Medicina (Kaunas). 2014;50(4):230-6. doi: 10.1016/j.medici.2014.09.010. Epub 2014 Oct 7.'}, {'pmid': '19243933', 'type': 'BACKGROUND', 'citation': 'Mannino M, Yarnold JR. Shorter fractionation schedules in breast cancer radiotherapy: clinical and economic implications. Eur J Cancer. 2009 Mar;45(5):730-1. doi: 10.1016/j.ejca.2009.01.024. Epub 2009 Feb 23. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Accelerated hypofractionated 1 week post-mastectomy chest wall irradiation in breast cancer patients will presumably produce comparable toxicity and disease control in comparison to 3 weeks schedule.\n\nThe aim is to evaluate toxicity and disease control after implementation of accelerated hypofractionated 1 week chest wall irradiation in breast cancer patients.', 'detailedDescription': 'Operational Design Patient Assessment Pre-radiotherapy assessment is done to provide a baseline for use in further follow-up and to rule out metastasis. This includes detailed history taking, full physical examination, hematological and biochemical laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for left cancer breast, bone scan if indicated.\n\nTreatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.\n\nSetup, simulation and target definition For setup, patients were positioned on a wingboard with both arms raised above the head and radiopaque markers along breast borders. Subsequently, the 5-mm slice-thick axial CT images were acquired from the lower mandible aspect to 5 cm below contralateral inframammary fold. The CT images will be automatically transferred to a planning workstation, where the CTV and relevant organs-at-risk (OARs) will be outlined. The planning of the tangential fields will be based on the target volume delineation for the dose-volume distribution analysis. The heart and ipsilateral lung were separately contoured as organs at risk, the heart was outlined to the pulmonary trunk superiorly, including pericardium and excluding major vessels. For setup verification purposes, weekly digitally reconstructed radiographs (DRRs) were performed.\n\nEvaluation of Treatment Follow-up is done for assessment of toxicity and disease-free and overall survival.\n\nDuring follow-up, patients are examined after completion of radiotherapy and at 3 and 6 months. Surveillance includes a full clinical examination, hematological and biochemical laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for left cancer breast, bone scan if indicated.\n\nAcute skin toxicity was assessed at the completion of radiotherapy and after 3 months (RTOG 2015), late skin toxicity was scored from 6 months after radiation and referred to the time of last examination (LENT/Soma Tables 1995). The maximal detected toxicity was scored according to the Common Terminology Criteria for Adverse Events, version 3.0, using the RTOG/EORTC toxicity scale associated with radiation as reference (NCI 2013) (Cox et al, 1995).\n\nAdmininistrative Design\n\nApprovals for performing this study are obtained from:\n\nA) The recruited cases; B) The Institutional Review Board (IRB) RESULTS Collected data will be presented in tables and suitable graphs and analyzed using SSPS package. Mean and standard deviations will be estimated for quantitative data and median for non-normally distributed data. Actuarial or life tables analysis will be used for estimating survival and long-rank test for comparison of curves. P value is significant at 0.05 level.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histological diagnosis of breast adenocarcinoma\n* prior modified radical mastectomy\n* negative resection margins (3 mm)\n* pathological stage pT1-pT2, N0-2 (AJCC, 2017)\n* no macroscopic evidence of distant metastases at diagnosis\n* Age 18-80 years\n* Normal hematological and biochemical laboratory tests\n* Written informed consent was obtained from all patients\n\nExclusion Criteria:\n\n* locally advanced disease pT3-pT4, N3\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'}, 'identificationModule': {'nctId': 'NCT05591456', 'briefTitle': 'Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'Radiotherapy in Breast Cancer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'The first group 50 patient (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week,', 'interventionNames': ['Radiation: adjuvant radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2', 'description': 'the second group 50 patient (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.', 'interventionNames': ['Radiation: adjuvant radiotherapy']}], 'interventions': [{'name': 'adjuvant radiotherapy', 'type': 'RADIATION', 'description': 'Treatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.', 'armGroupLabels': ['group 1', 'group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44511', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Zagazig university hospitals', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Rawda Balata, dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zagazig University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Rawda Ahmed Abdul Hakim Balata', 'investigatorAffiliation': 'Zagazig University'}}}}