Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT00527293
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2007-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018270', 'term': 'Carcinoma, Ductal, Breast'}], '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': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D001918', 'term': 'Brachytherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2007-09-07', 'studyFirstSubmitQcDate': '2007-09-07', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon', 'timeFrame': '1 month after RT & Q3mos for one year'}, {'measure': 'Patient satisfaction with partial breast irradiation as measured by a questionnaire', 'timeFrame': 'Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr'}, {'measure': 'Wound healing and overall complication rate after partial breast irradiation', 'timeFrame': '1 month after RT & Q3mos for one year'}, {'measure': 'Determination of which patients are best suited for each individual technique of partial breast irradiation', 'timeFrame': 'Patients will be followed for a period of five years following completion of radiation.'}, {'measure': 'Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates', 'timeFrame': 'Ipsilateral breast 6 mos after dx, bilateral annually x 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer', 'invasive ductal breast carcinoma', 'medullary ductal breast carcinoma with lymphocytic infiltrate', 'mucinous ductal breast carcinoma', 'tubular ductal breast carcinoma', 'papillary ductal breast carcinoma'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.\n\nPURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.', 'detailedDescription': "OBJECTIVES:\n\n* To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques.\n* To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire.\n* To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique.\n* To evaluate wound healing and overall complication rate after partial breast irradiation.\n* To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.\n\nOUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days.\n\nAfter completion of study therapy, patients are followed periodically for up to 5 years."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer, including the following histologic subtypes:\n\n * Invasive ductal carcinoma\n * Medullary ductal carcinoma\n * Papillary ductal carcinoma\n * Colloid (mucinous) ductal carcinoma\n * Tubular ductal carcinoma\n* The following histologic subtypes are not allowed:\n\n * Invasive lobular carcinoma\n * Extensive lobular carcinoma in situ\n * Ductal carcinoma in situ (DCIS)\n * Nonepithelial breast malignancies, such as lymphoma or sarcoma\n* No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue)\n* Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)\n\n * Lesion ≤ 3 cm\n * No more than 3 positive lymph nodes\n\n * Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible\n* Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy)\n\n * Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin\n* Unifocal breast cancer\n\n * No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm)\n\n * No palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative\n* No skin involvement of disease\n* No Paget's disease of the nipple\n* No distant metastatic disease\n* Hormone-receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Menopausal status not specified\n* Not pregnant or lactating\n* Negative pregnancy test\n* Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment\n* No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis\n* No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent\n* No other malignancy within the past 5 years, except non-melanomatous skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior radiotherapy to the breast\n* No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy\n* Concurrent hormonal therapy allowed"}, 'identificationModule': {'nctId': 'NCT00527293', 'briefTitle': 'Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study', 'orgStudyIdInfo': {'id': 'CASE2104'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE2104', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MammoSite Brachytherapy', 'description': 'Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days', 'interventionNames': ['Procedure: adjuvant therapy', 'Radiation: brachytherapy']}, {'type': 'EXPERIMENTAL', 'label': '3-dimensional conformal radiotherapy', 'description': '3-dimensional conformal radiotherapy twice daily for 5-10 days.', 'interventionNames': ['Procedure: adjuvant therapy', 'Radiation: 3-dimensional conformal radiation therapy']}], 'interventions': [{'name': 'adjuvant therapy', 'type': 'PROCEDURE', 'description': 'If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.', 'armGroupLabels': ['3-dimensional conformal radiotherapy', 'MammoSite Brachytherapy']}, {'name': '3-dimensional conformal radiation therapy', 'type': 'RADIATION', 'description': '3-dimensional conformal radiotherapy twice daily for 5-10 days.', 'armGroupLabels': ['3-dimensional conformal radiotherapy']}, {'name': 'brachytherapy', 'type': 'RADIATION', 'description': 'Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days', 'armGroupLabels': ['MammoSite Brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44060', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lake/University Ireland Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'UHHS Chagrin Highlands Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44145', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'UHHS Westlake Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Janice Lyons, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}