Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-01-18 @ 10:59 PM
Study NCT ID:
NCT03643861
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2018-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)
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': 'RECRUITING', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0', 'timeFrame': '0-2 years', 'description': 'To determine the safety of 5 fractions SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study.'}], 'secondaryOutcomes': [{'measure': 'Toxicity of breast SBRT using CTCAE v4.0', 'timeFrame': '0-2 years', 'description': 'To define the acute (\\<90 days) and late toxicity (\\>90 days) up to two years after breast SBRT (CTCAE 4) attributable to therapy.'}, {'measure': 'Cosmetic outcome baseline and post-SBRT', 'timeFrame': '0-2 years', 'description': 'To determine patient and nurse assessed cosmetic outcome at baseline and 1, 6, 12, 18, 24, and 36 months post SBRT. Patient will give a verbal satisfaction rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor of their cosmetic appearance post-SBRT. Nurse will also give their overall rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor based off of their examination of the cosmetic appearance post-SBRT.'}, {'measure': 'Patient reported outcome baseline and post-SBRT', 'timeFrame': '0-2 years', 'description': 'To determine patient reported outcome at baseline and 1, 6, 12, 18, 24, and 36 months post SBRT. The Quality of Life Breast Cancer Questionnaire (QLQ-BR45) is a 45-item questionnaire is composed of 45 questions with scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the QLQ-BR45 range from 45 to 180, with a lower score representing a higher quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['SBRT', 'Breast cancer', 'Early stage', 'Radiation therapy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '35880164', 'type': 'DERIVED', 'citation': 'Liu Y, Veale C, Hablitz D, Krontiras H, Dalton A, Meyers K, Dobelbower M, Lancaster R, Bredel M, Parker C, Keene K, Thomas E, Boggs D. Feasibility and Short-Term Toxicity of a Consecutively Delivered Five Fraction Stereotactic Body Radiation Therapy Regimen in Early-Stage Breast Cancer Patients Receiving Partial Breast Irradiation. Front Oncol. 2022 Jul 8;12:901312. doi: 10.3389/fonc.2022.901312. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.', 'detailedDescription': 'This study offers 5 fractions stereotactic body radiotherapy for early stage breast cancer after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility of delivering only 5 doses of radiation treatment rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 36 months (2 years) with follow-up appointments at 6, 12, 18, 24, and 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed.\n* Age\\>50.\n* Maximum pathologic tumor size \\<2.0cm if invasive carcinoma or \\< 2.5cm if pure DCIS.\n* Estrogen receptor (ER) positive (\\>10%).\n* Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm.\n* Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative.\n* Zubrod Performance Status 0-2.\n\nExclusion Criteria:\n\n* Multifocal or multicentric cancer.\n* Reception of neoadjuvant chemotherapy.\n* Pure invasive lobular histology.\n* Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.\n* Measured maximum PTV of \\>124cc.\n* Lumpectomy cavity within 5mm of body contour.'}, 'identificationModule': {'nctId': 'NCT03643861', 'briefTitle': 'RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'RAD 1802: A Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)', 'orgStudyIdInfo': {'id': 'IRB-300002157'}, 'secondaryIdInfos': [{'id': '000521633', 'type': 'OTHER_GRANT', 'domain': 'Varian Medical Systems'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5 Fraction Breast Stereotactic Body Radiation Therapy', 'description': 'This study will enroll patients that have a confirmed histology of early stage breast cancer. The patient will undergo a lumpectomy and will then receive partial breast 5 fractions stereotactic body radiation therapy at a dose of 6 gy for 5 fractions for treatment. Patients will be followed for 36 total months with specific follow-ups at 3, 6, 9, 12, 18, 24, and 36 months.', 'interventionNames': ['Radiation: 5 Fraction Stereotactic Body Radiation Therapy']}], 'interventions': [{'name': '5 Fraction Stereotactic Body Radiation Therapy', 'type': 'RADIATION', 'description': 'Stereotactic body radiation therapy (SBRT) has gained favor in the treatment of select central nervous system, lung, and abdominal malignancies due to its ability to deliver highly conformal doses of radiotherapy while using sharp dose gradients to deliver comparatively lower doses to the surrounding normal tissue. Utilization of SBRT is more labor intensive than conventional fractionation and requires precise immobilization and localization techniques with daily image guidance with direct physician and physicist oversight for all treatments. While more labor intensive and often utilizing more advanced technologies, SBRT allows the advantage of reducing setup margins compared to conventionally fractionated treatment while being able to shorten overall treatment times due to the ability to safely dose escalate high risk areas', 'armGroupLabels': ['5 Fraction Breast Stereotactic Body Radiation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'D. Hunter Boggs, MD', 'role': 'CONTACT', 'email': 'dhboggs@uabmc.edu', 'phone': '(205) 934-5670'}, {'name': 'D. Hunter Boggs, MD', 'role': 'CONTACT', 'email': 'dhboggs@uabmc.edu', 'phone': '(205) 975-5581'}], 'overallOfficials': [{'name': 'D. Hunter Boggs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Varian Medical Systems', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Drexell Hunter Boggs', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}