Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 6:08 AM
Study NCT ID:
NCT05394194
Status:
UNKNOWN
Last Update Posted:
2022-05-27
First Post:
2022-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dosimetric Comparison of Three Radiation Techniques for Hypofractionated Whole Breast Radiotherapy in 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of coverage of planned target volume(PTV) among the three plans.', 'timeFrame': '1 year', 'description': 'PTV coverage in dose is compared among the three plans.'}, {'measure': 'Comparison of doses to organs at risk among the three plans.', 'timeFrame': '1 year', 'description': 'mean dose of the heart, lung volume receiving 20Gy, esophageal doses will be compared among the three plans'}], 'secondaryOutcomes': [{'measure': 'Comparison of target homogeneity among the three plans.', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['computer assisted, radiotherapy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'We aim to compare three different radiation delivery techniques, namely three-dimensional conformal radiation therapy (3D-CRT), intensity modulated radiotherapy (IMRT) and volumetric modulated radiation therapy (VMAT) in left-sided early breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '30 Female patients who will present to clinical Oncology department with early breast cancer, with pathological staging ≤ T2N0M0 and are operated by conservative breast surgery will be included in our current study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* left sided early breast cancer patients. Should have histopathological prove to have invasive breast cancer. Operated by breast conservative surgery. Have no associated comorbidities\n\nExclusion Criteria:\n\n* locally advanced breast cancer. Patients who have total mastectomy. Patients who had previous chest irradiation or known comorbidities.'}, 'identificationModule': {'nctId': 'NCT05394194', 'briefTitle': 'Dosimetric Comparison of Three Radiation Techniques for Hypofractionated Whole Breast Radiotherapy in Early Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Dosimetric Comparison of Three Radiation Techniques for Hypofractionated Whole Breast Radiotherapy in Early Breast Cancer', 'orgStudyIdInfo': {'id': 'Soh-Med-22-05-24'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3DCRT group', 'description': 'In this plan, we will create plans using three dimensional conformal radiotherapy, evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans.'}, {'label': 'IMRT group', 'description': 'In this plan, we will create plans using intensity modulated radiotherapy (IMRT), evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans.'}, {'label': 'VMAT plan', 'description': 'In this plan, we will create plans using volumetric modulated radiotherapy (VMAT), evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alshaymaa Abdelghaffar, PhD', 'role': 'CONTACT', 'email': 'alshimaaahmed@med.sohag.edu.eg', 'phone': '01006828975', 'phoneExt': '002'}, {'name': 'Emad Eldin Nabil Hassan, PhD', 'role': 'CONTACT', 'email': 'emadd122@yahoo.com', 'phone': '01227014556', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Alshaymaa Abdelghaffar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Oncology', 'investigatorFullName': 'Alshaymaa Abdelghaffar', 'investigatorAffiliation': 'Sohag University'}}}}