Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT01413269
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2011-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 720}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2011-08-09', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'in-breast recurrence rate', 'timeFrame': '5 year', 'description': 'evidence of ipsilateral breast local recurrence confirmed by histology'}], 'secondaryOutcomes': [{'measure': 'regional node recurrence rate', 'timeFrame': '5 year', 'description': 'ipsilateral axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examination, image evaluation or histology.'}, {'measure': 'disease-free survival', 'timeFrame': '5 year', 'description': 'locoregional relapse, distant relapse, death'}, {'measure': 'overall survival', 'timeFrame': '5 year', 'description': 'any death'}, {'measure': 'acute toxicity', 'timeFrame': '6 months', 'description': 'radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria'}, {'measure': 'late complication', 'timeFrame': '3 -10 year', 'description': 'breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer patients', 'breast conservation surgery', 'hypofractionated radiotherapy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '32780661', 'type': 'DERIVED', 'citation': 'Wang SL, Fang H, Hu C, Song YW, Wang WH, Jin J, Liu YP, Ren H, Liu J, Li GF, Du XH, Tang Y, Jing H, Ma YC, Huang Z, Chen B, Tang Y, Li N, Lu NN, Qi SN, Yang Y, Sun GY, Liu XF, Li YX. Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China. J Clin Oncol. 2020 Nov 1;38(31):3604-3614. doi: 10.1200/JCO.20.01024. Epub 2020 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. KPS\\>=60\n2. histology confirmed invasive breast cancer\n3. received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)\n4. surgical margins negative\n5. primary tumor ≤5cm in the largest diameter\n6. no internal mammary node or supraclavicular node metastases or distant metastasis\n7. can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy\n8. for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date\n9. for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy\n10. patients signed written inform consent form\n\nExclusion Criteria:\n\n1. ductal carcinoma in situ\n2. prior neoadjuvant chemotherapy\n3. prior breast cancer history\n4. bilateral breast cancer\n5. pregnant or during lactation\n6. prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ\n7. active collagen vascular disease\n8. prior neoadjuvant hormone therapy\n9. immediate ipsilateral breast reconstruction'}, 'identificationModule': {'nctId': 'NCT01413269', 'briefTitle': 'Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery', 'orgStudyIdInfo': {'id': 'CH-BC-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hypofractionation radiotherapy', 'description': 'irradiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.', 'interventionNames': ['Radiation: radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional fractionation radiotherapy', 'description': 'irradiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.', 'interventionNames': ['Radiation: radiotherapy']}], 'interventions': [{'name': 'radiotherapy', 'type': 'RADIATION', 'description': 'one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.\n\nthe other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.', 'armGroupLabels': ['conventional fractionation radiotherapy', 'hypofractionation radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'ye-xiong Li, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, {'name': 'Shu-lian Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Shu lian Wang', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}