Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-29 @ 3:21 PM
Study NCT ID:
NCT02266602
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2014-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Radiation Therapy in Early Stage 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': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2014-10-10', 'studyFirstSubmitQcDate': '2014-10-14', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Disease Relapse', 'timeFrame': '10 years', 'description': 'Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence. In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease. Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).'}], 'secondaryOutcomes': [{'measure': 'Disease specific and overall survival', 'timeFrame': '10 years', 'description': 'Disease specific and overall survival will be obtained for all patients in the study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IORT', 'Breast Cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.', 'detailedDescription': 'The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of:\n\n* Local recurrence in early stage breast cancer patients treated with IORT.\n* Toxicity associated with IORT.\n* Long-term disease-specific and overall survival\n* Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.\n* Quality of life in patients treated with IORT.\n* Health care costs associated with IORT.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral Inclusion Criteria\n\n1. Age ≥ 45 years.\n2. Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).\n3. Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.\n\nExclusion Criteria:\n\n1. Scleroderma, systemic sclerosis and active lupus.\n2. Participation in an investigational drug or device study.\n3. Previous ipsilateral radiation to the thorax or breast.\n4. Multifocal breast cancer.\n5. Pregnant patients.\n6. Patient not competent to provide informed consent.\n7. Neoadjuvant systemic therapy.\n8. Lymphovascular invasion on biopsy pathology'}, 'identificationModule': {'nctId': 'NCT02266602', 'acronym': 'IORTBreast', 'briefTitle': 'Intraoperative Radiation Therapy in Early Stage Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Benaroya Research Institute'}, 'officialTitle': 'Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer', 'orgStudyIdInfo': {'id': '11143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'description': 'Patients treated with intraoperative radiation therapy at the time of partial mastectomy.', 'interventionNames': ['Radiation: Intraoperative Radiation Therapy']}], 'interventions': [{'name': 'Intraoperative Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['IORT'], 'description': 'Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Janie Grumley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Mason Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benaroya Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Michelle Yao', 'investigatorAffiliation': 'Benaroya Research Institute'}}}}