Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-27 @ 5:08 AM
Study NCT ID:
NCT02104895
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2014-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'icro.meattini@unifi.it', 'phone': '+39055794', 'title': 'Dr. Icro Meattini', 'phoneExt': '7719', 'organization': 'Radiation-Oncology Unit, AOU Careggi, Florence University, Florence, Italy'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5-years', 'description': 'Acute and late skin toxicity, any grade', 'eventGroups': [{'id': 'EG000', 'title': 'Whole Breast Irradiation (WBI)', 'description': 'Conventional whole breast irradiation (WBI)\n\nWhole breast irradiation (WBI): Conventional whole breast irradiation (WBI)', 'otherNumAtRisk': 260, 'otherNumAffected': 173, 'seriousNumAtRisk': 260, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Partial Breast Irradiation (APBI)', 'description': 'Accelerated partial breast irradiation (APBI)\n\nAccelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)', 'otherNumAtRisk': 246, 'otherNumAffected': 49, 'seriousNumAtRisk': 246, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'acute skin toxicity, any grade', 'notes': 'Here we report total rate of acute skin toxicity in each arm of the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 173}, {'groupId': 'EG001', 'numAtRisk': 246, 'numAffected': 49}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'late skin toxicity, any grade', 'notes': 'Here we report rate of late skin toxicity in each arm of the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 246, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ipsilateral Breast Tumor Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Breast Irradiation (WBI)', 'description': 'Conventional whole breast irradiation (WBI)\n\nWhole breast irradiation (WBI): Conventional whole breast irradiation (WBI)'}, {'id': 'OG001', 'title': 'Partial Breast Irradiation (APBI)', 'description': 'Accelerated partial breast irradiation (APBI)\n\nAccelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5-year', 'description': 'We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced "Ipsilateral Breast Tumor Recurrence"', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acute Skin Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Breast Irradiation (WBI)', 'description': 'Conventional whole breast irradiation (WBI)\n\nWhole breast irradiation (WBI): Conventional whole breast irradiation (WBI)'}, {'id': 'OG001', 'title': 'Partial Breast Irradiation (APBI)', 'description': 'Accelerated partial breast irradiation (APBI)\n\nAccelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)'}], 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Acute skin toxicity ≥ grade 2, here we report the percentage of participants in each arm who experienced "Acute skin toxicity ≥ grade 2', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Excellent Cosmesis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Breast Irradiation (WBI)', 'description': 'Conventional whole breast irradiation (WBI)\n\nWhole breast irradiation (WBI): Conventional whole breast irradiation (WBI)'}, {'id': 'OG001', 'title': 'Partial Breast Irradiation (APBI)', 'description': 'Accelerated partial breast irradiation (APBI)\n\nAccelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)'}], 'classes': [{'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000'}, {'value': '95.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Physician-rated cosmesis, Cosmetic outcome was scored on the four-category Harvard Breast Cosmesis Scale. An excellent cosmetic result score was assigned when the treated breast looked like the contralateral one; a good cosmetic score was assigned for minimal but identifiable radiation effects of the treated breast; a fair score was used if significant radiation effects were readily observable; a poor score was used for severe sequelae due to radiation effects', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Whole Breast Irradiation (WBI)', 'description': 'Conventional whole breast irradiation (WBI)\n\nWhole breast irradiation (WBI): Conventional whole breast irradiation (WBI)'}, {'id': 'FG001', 'title': 'Partial Breast Irradiation (APBI)', 'description': 'Accelerated partial breast irradiation (APBI)\n\nAccelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '260'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '246'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Whole Breast Irradiation (WBI)', 'description': 'Conventional whole breast irradiation (WBI)\n\nWhole breast irradiation (WBI): Conventional whole breast irradiation (WBI)'}, {'id': 'BG001', 'title': 'Partial Breast Irradiation (APBI)', 'description': 'Accelerated partial breast irradiation (APBI)\n\nAccelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-11', 'studyFirstSubmitDate': '2014-04-02', 'resultsFirstSubmitDate': '2015-11-25', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-29', 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ipsilateral Breast Tumor Recurrence', 'timeFrame': '5-year', 'description': 'We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced "Ipsilateral Breast Tumor Recurrence"'}], 'secondaryOutcomes': [{'measure': 'Acute Skin Toxicity', 'timeFrame': '5 years', 'description': 'Acute skin toxicity ≥ grade 2, here we report the percentage of participants in each arm who experienced "Acute skin toxicity ≥ grade 2'}, {'measure': 'Excellent Cosmesis', 'timeFrame': '5 years', 'description': 'Physician-rated cosmesis, Cosmetic outcome was scored on the four-category Harvard Breast Cosmesis Scale. An excellent cosmetic result score was assigned when the treated breast looked like the contralateral one; a good cosmetic score was assigned for minimal but identifiable radiation effects of the treated breast; a fair score was used if significant radiation effects were readily observable; a poor score was used for severe sequelae due to radiation effects'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'Early breast cancer', 'Adjuvant breast cancer', 'Accelerated partial breast irradiation', 'Intensity modulated radiotherapy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '19700248', 'type': 'RESULT', 'citation': 'Livi L, Buonamici FB, Simontacchi G, Scotti V, Fambrini M, Compagnucci A, Paiar F, Scoccianti S, Pallotta S, Detti B, Agresti B, Talamonti C, Mangoni M, Bianchi S, Cataliotti L, Marrazzo L, Bucciolini M, Biti G. Accelerated partial breast irradiation with IMRT: new technical approach and interim analysis of acute toxicity in a phase III randomized clinical trial. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):509-15. doi: 10.1016/j.ijrobp.2009.04.070. Epub 2009 Aug 21.'}, {'pmid': '25605582', 'type': 'RESULT', 'citation': 'Livi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, Saieva C, Paiar F, Scotti V, De Luca Cardillo C, Bastiani P, Orzalesi L, Casella D, Sanchez L, Nori J, Fambrini M, Bianchi S. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Eur J Cancer. 2015 Mar;51(4):451-463. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17.'}, {'pmid': '26350524', 'type': 'RESULT', 'citation': 'Meattini I, Saieva C, Marrazzo L, Di Brina L, Pallotta S, Mangoni M, Meacci F, Bendinelli B, Francolini G, Desideri I, De Luca Cardillo C, Scotti V, Furfaro IF, Rossi F, Greto D, Bonomo P, Casella D, Bernini M, Sanchez L, Orzalesi L, Simoncini R, Nori J, Bianchi S, Livi L. Accelerated partial breast irradiation using intensity-modulated radiotherapy technique compared to whole breast irradiation for patients aged 70 years or older: subgroup analysis from a randomized phase 3 trial. Breast Cancer Res Treat. 2015 Oct;153(3):539-47. doi: 10.1007/s10549-015-3565-2. Epub 2015 Sep 9.'}, {'pmid': '32840419', 'type': 'DERIVED', 'citation': 'Meattini I, Marrazzo L, Saieva C, Desideri I, Scotti V, Simontacchi G, Bonomo P, Greto D, Mangoni M, Scoccianti S, Lucidi S, Paoletti L, Fambrini M, Bernini M, Sanchez L, Orzalesi L, Nori J, Bianchi S, Pallotta S, Livi L. Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial. J Clin Oncol. 2020 Dec 10;38(35):4175-4183. doi: 10.1200/JCO.20.00650. Epub 2020 Aug 24.'}, {'pmid': '30474504', 'type': 'DERIVED', 'citation': 'Becherini C, Meattini I, Livi L, Garlatti P, Desideri I, Scotti V, Orzalesi L, Sanchez LJ, Bernini M, Casella D, Nesi S, Nori J, Bianchi S, Pallotta S, Marrazzo L. External accelerated partial breast irradiation for ductal carcinoma in situ: long-term follow-up from a phase 3 randomized trial. Tumori. 2019 Jun;105(3):205-209. doi: 10.1177/0300891618811278. Epub 2018 Nov 26.'}, {'pmid': '28262584', 'type': 'DERIVED', 'citation': 'Meattini I, Saieva C, Miccinesi G, Desideri I, Francolini G, Scotti V, Marrazzo L, Pallotta S, Meacci F, Muntoni C, Bendinelli B, Sanchez LJ, Bernini M, Orzalesi L, Nori J, Bianchi S, Livi L. Accelerated partial breast irradiation using intensity modulated radiotherapy versus whole breast irradiation: Health-related quality of life final analysis from the Florence phase 3 trial. Eur J Cancer. 2017 May;76:17-26. doi: 10.1016/j.ejca.2017.01.023. Epub 2017 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole breast radiotherapy to accelerated partial breast irradiation using intensity-modulated radiotherapy technique in selected early breast cancer patients after breast conserving surgery.', 'detailedDescription': 'The surgeons were requested to place clips at the borders of the surgical bed, using a minimum of four clips. The presence of surgical clips was a selection criterion to avoid geographic misses. Computed tomography (CT) scanning was performed using 0.3-cm thick-slices and a slice spacing of 0.3 cm.\n\nIn patients assigned to APBI arm, the clinical target volume (CTV) was drawn with a uniform 1-cm three-dimensional margin around the surgical clips. The CTV was limited to 3 mm from the skin surface and 3 mm from the lung-chest wall interface. A second uniform, three-dimensional 1-cm margin was added to the CTV to obtain the planning target volume (PTV). The PTV was allowed to extend 4 mm inside the ipsilateral lung and was limited to 3 mm from the skin. The ipsilateral and contralateral breast, ipsilateral and contralateral lung, heart, and spinal cord were contoured as organs at risk.\n\nAll the regions of interest were contoured according to the International Commission on Radiation Units and Measurements reports 50 and 62 recommendations. No respiratory control was used.\n\nConcerning the experimental Arm (accelerated partial breast irradiation), a dose of 30 Gy in five fractions at 6 Gy/fraction was prescribed.\n\nThe following constraints were adopted for plan optimization: PTV coverage: 100% of PTV covered by 95% of the prescribed dose (V28.5 = 100%); maximal dose to PTV \\<105% (31.5 Gy); minimal dose to PTV 28 Gy; uninvolved breast (i.e., ipsilateral breast without PTV): not \\>50% covered by a dose of \\>50% of the prescribed dose (V15 \\<50%); ipsilateral lung: not \\>20% covered by a dose \\>10 Gy (V10\\<20%); contralateral lung: not \\>10% covered by a dose \\>5 Gy (V5\\<10%); contralateral breast: maximal dose \\<1 Gy; heart: not \\>10% covered by a dose \\>3 Gy (V3 \\<10%).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at presentation \\>40 y\n* Tumor size \\<25 mm\n* Wide excision or quadrantectomy with clear margins (\\>5 mm)\n* Clips placed in tumor bed\n* Full informed consent from patient\n\nExclusion Criteria:\n\n* Cardiac dysfunction\n* Forced expiratory volume in 1 second (FEV1) \\<1 L/m\n* Extensive intraductal carcinoma\n* Multifocal cancer\n* Psychiatric problems\n* Recurrent breast cancer'}, 'identificationModule': {'nctId': 'NCT02104895', 'briefTitle': 'Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria Careggi'}, 'officialTitle': 'Randomised Phase 3 Trial Of Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation', 'orgStudyIdInfo': {'id': 'APBI-IMRT-Florence'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Whole breast irradiation (WBI)', 'description': 'Conventional whole breast irradiation (WBI)', 'interventionNames': ['Radiation: Whole breast irradiation (WBI)']}, {'type': 'EXPERIMENTAL', 'label': 'Partial breast irradiation (APBI)', 'description': 'Accelerated partial breast irradiation (APBI)', 'interventionNames': ['Radiation: Accelerated partial breast irradiation (APBI)']}], 'interventions': [{'name': 'Accelerated partial breast irradiation (APBI)', 'type': 'RADIATION', 'description': 'Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)', 'armGroupLabels': ['Partial breast irradiation (APBI)']}, {'name': 'Whole breast irradiation (WBI)', 'type': 'RADIATION', 'description': 'Conventional whole breast irradiation (WBI)', 'armGroupLabels': ['Whole breast irradiation (WBI)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lorenzo Livi, Full Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florence University'}, {'name': 'Icro Meattini, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero-Universitaria Careggi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor; Chief Radiotherapy-Oncology Unit; Florence University', 'investigatorFullName': 'Lorenzo Livi', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria Careggi'}}}}