Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-01 @ 7:19 AM
Study NCT ID:
NCT04913532
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2021-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionation With Simultaneous Integrated Boost 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2021-05-30', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Skin toxicity (Cosmetic results)', 'timeFrame': '0 to 6 months', 'description': 'RTOG'}], 'primaryOutcomes': [{'measure': 'Acute Toxicity', 'timeFrame': '6 months', 'description': 'Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE'}], 'secondaryOutcomes': [{'measure': 'Feasibility of the radiation plan', 'timeFrame': '19 days', 'description': 'Dose constraints Dmean lung \\< 10 Gy; Dmean heart \\< 5 Gy, Dmedian contralateral breast \\< 4Gy'}, {'measure': 'other acute Toxicity', 'timeFrame': '0-6 months', 'description': 'All dimensions of NCI-CTCAE/RTOG'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Surgery', 'Adjuvant Radiotherapy']}, 'descriptionModule': {'briefSummary': 'Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.\n\nInvestigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.', 'detailedDescription': 'Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins\n* Indication to adjuvant radiotherapy including boost radiotherapy\n* Clearly identified primary tumor region preferably by radiopaque clips\n* Primary wound healing after breast conserving therapy without signs of infection\n* Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients operated by mastectomy\n* No indication for boost radiation\n* Resection margins positive for disease or insufficient identification of the boost volume\n* Indication for radiotherapy of the regional lymph nodes\n* History of prior breast or thoracic radiotherapy\n* Extended postoperative seroma at the beginning of radiotherapy\n* Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance\n* Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception'}, 'identificationModule': {'nctId': 'NCT04913532', 'briefTitle': 'Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'A Phase II Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer', 'orgStudyIdInfo': {'id': '2020-q12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionation with SIB', 'description': 'Hypofractionation with SIB', 'interventionNames': ['Radiation: Hypofractionation with simultaneous integrated boost']}], 'interventions': [{'name': 'Hypofractionation with simultaneous integrated boost', 'type': 'RADIATION', 'description': 'Hypofractionation with simultaneous integrated boost', 'armGroupLabels': ['Hypofractionation with SIB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Shijitan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Wenjie Ni, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Shijitan Hospital, Capital Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Capital Medical University', 'investigatorFullName': 'Wenjie Ni', 'investigatorAffiliation': 'Capital Medical University'}}}}