Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-02-24 @ 9:57 AM
Study NCT ID:
NCT01185132
Status:
RECRUITING
Last Update Posted:
2014-06-26
First Post:
2010-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 660}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2010-08-18', 'studyFirstSubmitQcDate': '2010-08-18', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)', 'timeFrame': '5 years', 'description': 'Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit'}, {'measure': 'Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)', 'timeFrame': '2-5 years', 'description': 'Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit'}], 'secondaryOutcomes': [{'measure': 'Dosimetric comparison', 'timeFrame': '5-10 days', 'description': 'Comparison of treatment plans and actual doses received between comparable patients treated with 3D-CRT and IMRT with regard to treatment target and normal tissue'}, {'measure': 'Acute skin reactions', 'timeFrame': '6 months', 'description': 'Radiation-induced dermatitis'}, {'measure': 'Cosmetic outcomes after APBI', 'timeFrame': '2-5 years', 'description': 'Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit'}, {'measure': 'Ipsilateral breast event', 'timeFrame': '5-15 years', 'description': 'Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)'}, {'measure': 'Cause specific survival', 'timeFrame': '5-15 years', 'description': 'Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)'}, {'measure': 'Disease free survival', 'timeFrame': '5-15 years', 'description': 'Track breast-cancer free survival status of study participants (efficacy outcome measure)'}, {'measure': 'Overall survival', 'timeFrame': '5-15 years', 'description': 'Track the overall survival status of all study participants (efficacy outcome measure)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast-conservation', 'adjuvant radiotherapy', 'breast cancer', 'early-stage breast cancer', 'DCIS', 'lumpectomy', 'accelerated partial breast irradiation', 'APBI', 'three dimensional conformal external radiotherapy', 'intensity modulated radiotherapy', '3D CRT', 'IMRT'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34469056', 'type': 'DERIVED', 'citation': 'Leonard CE, Wang Y, Asmar L, Lei RY, Howell KT, Henkenberns PL, Johnson TK, Hobart TL, Tole SP, Kercher JM, Widner JL, Barke L, Kaske T, Carter DL. A prospective Phase III trial evaluating patient self-reported pain and cosmesis in accelerated partial breast irradiation utilizing 3-D versus intensity-modulated radiotherapy. Cancer Med. 2021 Oct;10(20):7089-7100. doi: 10.1002/cam4.4242. Epub 2021 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0.\n* Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.\n* Negative surgical margins ( ≥ 0.2 cm) after final surgery.\n* Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease.\n* Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.\n* Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease.\n* Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.\n* Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4.\n* Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials.\n* PTV to ipsilateral breast ratio (IBR) ≤ 25 %.\n* Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding.\n* Have collagen-vascular disease.\n* Inadequate surgical margins ( \\< 0.2 cm) after final surgery.\n* Subjects with persistent malignant/suspicious micro-calcifications.\n* Gross multifocal disease and microscopic disease greater than 3.0 cm.'}, 'identificationModule': {'nctId': 'NCT01185132', 'acronym': '2009-APBI', 'briefTitle': 'Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy', 'organization': {'class': 'OTHER', 'fullName': 'Rocky Mountain Cancer Centers'}, 'officialTitle': 'A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy', 'orgStudyIdInfo': {'id': '2009-APBI'}, 'secondaryIdInfos': [{'id': 'WIRB #20091193', 'type': 'OTHER', 'domain': 'Western IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMRT', 'description': 'Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days', 'interventionNames': ['Radiation: accelerated partial breast irradiation - IMRT planning']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3D-CRT', 'description': 'Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days', 'interventionNames': ['Radiation: accelerated partial breast irradiation - 3D-conformal planning']}], 'interventions': [{'name': 'accelerated partial breast irradiation - 3D-conformal planning', 'type': 'RADIATION', 'otherNames': ['APBI', 'EBRT'], 'description': '38.5 Gy, 10 fractions over 5 days', 'armGroupLabels': ['3D-CRT']}, {'name': 'accelerated partial breast irradiation - IMRT planning', 'type': 'RADIATION', 'otherNames': ['APBI', 'EBRT'], 'description': '38.5 Gy, 10 fractions over 5 days', 'armGroupLabels': ['IMRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dennis Carter, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'William Daniel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kathryn Howell, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rocky Mountain Cancer Centers - Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80303', 'city': 'Boulder', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Antell, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Meera Patel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ralph Wright, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rocky Mountain Cancer Centers - Boulder', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ralph Wright, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charles Leonard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rocky Mountain Cancer Centers - Lakewood', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles Leonard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kathryn Howell, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rocky Mountain Cancer Centers - Littleton', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '80260', 'city': 'Thornton', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert LaPorte, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Chin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rocky Mountain Cancer Centers - Thornton', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}], 'centralContacts': [{'name': 'Rachel Lei, BS', 'role': 'CONTACT', 'email': 'rachel.lei@usoncology.com', 'phone': '303-418-7607'}, {'name': 'Charles Leonard, MD', 'role': 'CONTACT', 'phone': '303-730-4700'}], 'overallOfficials': [{'name': 'Charles Leonard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rocky Mountain Cancer Centers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rocky Mountain Cancer Centers', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}