Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT00909818
Status:
UNKNOWN
Last Update Posted:
2021-08-24
First Post:
2009-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}], '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': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069473', 'term': 'Radiation Dose Hypofractionation'}], 'ancestors': [{'id': 'D019583', 'term': 'Dose Fractionation, Radiation'}, {'id': 'D011879', 'term': 'Radiotherapy Dosage'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 976}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2009-05-28', 'studyFirstSubmitQcDate': '2009-05-28', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade 2 or 3 fibrosis 3 years after radiotherapy', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Carcinoma in Situ of the Breast']}, 'referencesModule': {'references': [{'pmid': '32910709', 'type': 'DERIVED', 'citation': 'Offersen BV, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Krause M, Stenbygaard L, Mjaaland I, Schreiber A, Kasti UM, Overgaard J; Danish Breast Cancer Group Radiation Therapy Committee. Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial. J Clin Oncol. 2020 Nov 1;38(31):3615-3625. doi: 10.1200/JCO.20.01363. Epub 2020 Sep 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.', 'detailedDescription': 'The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity.\n\nThe hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '41 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* operated with breast conserving strategy for:\n\n 1. invasive breast cancer, pT1-2, pN0-1mi, M0 OR\n 2. carcinoma in situ of the breast\n\nExclusion Criteria:\n\n* previous radiation of the breast/thorax\n* breast implants\n* pregnant/lactating\n* comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years'}, 'identificationModule': {'nctId': 'NCT00909818', 'briefTitle': 'Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Danish Breast Cancer Cooperative Group'}, 'officialTitle': 'Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase III Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)', 'orgStudyIdInfo': {'id': 'DBCG hypo protocol'}, 'secondaryIdInfos': [{'id': 'CIRRO IP030209'}, {'id': 'The Danish Cancer Society'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard fractionated radiotherapy', 'description': '50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week', 'interventionNames': ['Radiation: standard fractionated radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'hypofractionated radiotherapy', 'description': 'hypofractionated radiotherapy 40 Gy/15 fractions', 'interventionNames': ['Radiation: hypofractionated radiotherapy']}], 'interventions': [{'name': 'standard fractionated radiotherapy', 'type': 'RADIATION', 'description': 'standard fractionated radiotherapy 50 Gy/25 fractions', 'armGroupLabels': ['standard fractionated radiotherapy']}, {'name': 'hypofractionated radiotherapy', 'type': 'RADIATION', 'description': 'hypofractionated radiotherapy 40 Gy/15 fractions', 'armGroupLabels': ['hypofractionated radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100 Ø', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'The Danish Breast Cancer Cooperative Group', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Lars Stenbygaard, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aalborg University Hospital'}, {'name': 'Birgitte Offersen, MD, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Erik Jakobsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vejle Hospital'}, {'name': 'Mette H Nielsen, MD, phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Odense University Hospital'}, {'name': 'Birgitte Offersen, MD, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Mechthild Krause, M.D., Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'University Clinic Carl Gustav Carus Dresden'}, {'name': 'Andreas Schreiber, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt'}, {'name': 'Ingvil Mjaaland, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Helse Stavanger HF, Sorlandet Sykehus HF'}, {'name': 'Unn-Miriam Kasti, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Kristiansand Sykehus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Breast Cancer Cooperative Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., ph.d., associate professor', 'investigatorFullName': 'Birgitte Offersen', 'investigatorAffiliation': 'Danish Breast Cancer Cooperative Group'}}}}