Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-31 @ 2:44 AM
Study NCT ID:
NCT06984250
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2025-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 315}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ipsilateral breast tumor recurrence', 'timeFrame': 'From enrollment to the end of treatment at 2 years', 'description': 'The time from the date of completion of radiotherapy to the date of ipsilateral breast recurrence or death, whichever occurs first. Unit of Measure: Time-to-event (months)'}], 'secondaryOutcomes': [{'measure': 'Early Phase Acute Skin Toxicity', 'timeFrame': 'Up to 3 months following completion of radiotherapy', 'description': 'Acute skin toxicity assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), grading severity from Grade 0 (none) to Grade 5 (death). Unit of Measure: CTCAE Grade (0-5)'}, {'measure': 'Late Phase Breast Fibrosis', 'timeFrame': 'From 3 months up to 5 years following completion of radiotherapy', 'description': 'Late breast fibrosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), grading severity from Grade 0 (none) to Grade 5 (death). Unit of Measure: CTCAE Grade (0-5)'}, {'measure': 'Patient Quality of Life (EORTC QLQ-C30)', 'timeFrame': 'At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years)', 'description': 'Quality of life evaluation using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Chinese Mandarin (Taiwan) version. Scores range from 0 to 100, with higher scores indicating better quality of life. Unit of Measure: Score (0-100)'}, {'measure': 'Patient Quality of Life (EORTC QLQ-BR23)', 'timeFrame': 'At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years)', 'description': 'Quality of life evaluation using the Breast Cancer Module (BR23) of the European Organization for Research and Treatment of Cancer, Chinese Mandarin (Taiwan) version. Scores range from 0 to 100, with higher scores indicating better quality of life. Unit of Measure: Score (0-100)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['breast cancer', 'concomitant boost', 'tumor bed', 'Intensity-modulated radiation therapy', 'hypofractionated breast radiotherapy'], 'conditions': ['Early Breast Cancer', 'Ductal Breast Carcinoma In Situ']}, 'descriptionModule': {'briefSummary': 'Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients diagnosed with early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS) who are undergoing breast-conserving surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with histologically confirmed early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS).\n* Patients undergoing breast-conserving surgery\n* Age ≥ 20 years\n* Karnofsky Performance Status (KPS) ≥70%\n* Life expectancy ≥ 5 years\n* Adequate renal and hepatic function\n\nExclusion Criteria:\n\n* Pregnant patients\n* Patients requiring re-irradiation of the thoracic region'}, 'identificationModule': {'nctId': 'NCT06984250', 'acronym': 'HFCBB', 'briefTitle': 'Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Hybrid Techniques Combining Hypofractionated Whole Breast Radiotherapy With Concomitant Tumor Bed Boost in Patients With Breast Cancer', 'orgStudyIdInfo': {'id': '202110027RINB'}, 'secondaryIdInfos': [{'id': '113-S0087', 'type': 'OTHER_GRANT', 'domain': 'National Taiwan University Hospital Yunlin Branch'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'CBB', 'description': 'Hypofractionated breast radiotherapy following partial mastectomy in patients with early breast cancer or ductal breast carcinoma in situ', 'interventionNames': ['Radiation: Hypofractionated Radiation Therapy']}], 'interventions': [{'name': 'Hypofractionated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Hypofractionated breast radiotherapy with concomitant boost'], 'description': 'Hypofractionated breast radiotherapy (HFRT) with hybrid techniques combining field-in-field intensity-modulated RT (FIF-IMRT) to the whole breast with inverse-IMRT for concomitant boost', 'armGroupLabels': ['CBB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yen-Ting Liu', 'role': 'CONTACT', 'email': 'nickliucool@ntuh.gov.tw', 'phone': '886972655451'}, {'name': 'Sung-Hsin Kuo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '632', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yen-Ting Liu', 'role': 'CONTACT', 'email': 'nickliucool@ntuh.gov.tw', 'phone': '886972655451'}, {'name': 'Yen-Ting Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital Yunlin Branch', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yen-Ting Liu', 'role': 'CONTACT', 'email': 'nickliucool@ntuh.gov.tw', 'phone': '88697255451'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'Anonymized patient-level clinical data necessary to replicate the main study findings'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}