Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT02003560
Status:
UNKNOWN
Last Update Posted:
2014-08-13
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accelerated Partial Breast Irradiation With 3D-CRT and IMRT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], '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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2013-12-02', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'quality of life', 'timeFrame': '5 years', 'description': 'quality of life measured by the EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and BR-23 questionnaires'}], 'primaryOutcomes': [{'measure': 'late radiation side-effect', 'timeFrame': '5 years', 'description': 'Late radiation side-effects at 5 years scored by the RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer) late radiation morbidity scoring scheme'}], 'secondaryOutcomes': [{'measure': 'cosmetic results', 'timeFrame': '5 years', 'description': 'cosmetic results at 5 years measured by the Harvard criteria'}, {'measure': 'local tumor control', 'timeFrame': '5 years', 'description': 'Local tumor control defined as reappearance of the tumor in the ipsilateral breast'}, {'measure': 'regional tumor control', 'timeFrame': '5 years', 'description': 'regional tumor control at 5 years'}, {'measure': 'overall survival', 'timeFrame': '5 years', 'description': 'overall survival at 5 years'}, {'measure': 'disease free survival', 'timeFrame': '5 years', 'description': 'disease free survival at 5 years'}, {'measure': 'cancer specific survival', 'timeFrame': '5 years', 'description': 'cancer specific survival at 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'breast conserving therapy', 'accelerated partial breast irradiation', '3D conformal radiotherapy', 'intensity modulated radiotherapy'], 'conditions': ['Breast Cancer', 'Radiation Toxicity', 'Side Effects']}, 'referencesModule': {'references': [{'pmid': '24619017', 'type': 'DERIVED', 'citation': 'Mozsa E, Meszaros N, Major T, Frohlich G, Stelczer G, Sulyok Z, Fodor J, Polgar C. Accelerated partial breast irradiation with external beam three-dimensional conformal radiotherapy. Five-year results of a prospective phase II clinical study. Strahlenther Onkol. 2014 May;190(5):444-50. doi: 10.1007/s00066-014-0633-1. Epub 2014 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine in a phase II clinical trial whether accelerated partial breast irradiation after breast conserving surgery using 3 dimensional external beam radiotherapy (3D-CRT) and intensity modulated radiotherapy (IMRT) for low-risk invasive breast cancer patients is safe without causing serious late radiation side-effects.', 'detailedDescription': 'It is a sequential phase II trial. Eligible patients after breast conserving surgery (BCS) are treated with accelerated partial breast irradiation (APBI) using three-dimensional conformal radiotherapy (3D-CRT) for the first 45 patients or intensity modulated radiotherapy (IMRT) for the second 45 patients.\n\nPrimary end-point of the study: late radiation side-effects at 5 years. Early stopping criteria: Not used as primary end-point is late side-effects. Interim analysis: Not planned Secondary end-points: cosmetic results, quality of life, local recurrence-free survival, regional recurrence free survival, distant metastasis free survival, relapse free survival, overall survival, cancer specific survival.\n\nNull-hypothesis for primary end-point: The incidence of severe (\\>G2) late radiation side-effects after APBI using 3D-CRT or IMRT will not exceed 10%.\n\nStratification:\n\n* by treatment delivery: 3D-CRT - first 45 patients; IMRT - second 45 patients\n* by bra capsize: Capsize A-B; C; and D-D+\n\nTreatment intervention: 9 x 4.1 Gy APBI using 3D-CRT (first 45 patients) or IMRT (second 45 patients) delivered within 5 days, using twice-a-day fractionation.\n\nClinical target volume (CTV) and Planning target volume (PTV) definition:\n\nCTV = excision cavity + 20 mm minus the actual pathological surgical margin in mm PTV = CTV + 5 mm in each direction\n\nFollow-up:\n\n* ECOG PS, physical examination (inspection and palpation), registration of side-effects (RTOG (Radiation Therapy Oncology Group) EORTC (European Organization for Research and Treatment of Cancer)) early and late radiation morbidity scoring scheme) and cosmetic results (using the Harvard scale) : 7-14 days after RT, than in every 3 months for 2 years, and every 6 months for 5 years.\n* Mammography: at 6, 12, 18, 24 months, and annually thereafter\n* Quality of life questionnaire (QLQ) (e.g. EORTC (European Organization for Research and Treatment of Cancer) QLQ-30 and Breast (BR)-23) before RT, at 7-14 days after RT, at 3, 6, and 12 months, and annually thereafter\n* digital photography: before treatment, at 7-14 days after treatment, and yearly thereafter'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previous breast conserving surgery within 12 weeks (in case of adjuvant chemotherapy within 28 days after completion of chemotherapy)\n* patient age \\> 40 years\n* ECOG performance status: 0-1\n* life expectancy \\>5 years\n* invasive ductal, papillary, mucinous, medullary or tubular carcinoma\n* unifocal tumor\n* pathological tumor size \\< or = 30 mm\n* pathological negative axillary nodal status with axillary dissection or sentinel lymph node biopsy\n* surgical clips in the tumor bed\n* pathological surgical free margins of at least 2 mm\n* written informed consent of patients\n\nExclusion Criteria:\n\n* Stage III-IV\n* multifocal tumor\n* extensive intraductal component (EIC)\n* ductal or lobular carcinoma in situ (DCIS or LCIS)\n* invasive lobular cancer (ILC)\n* lymph-vascular invasion (LVI)\n* contralateral breast cancer\n* history of treatment for previous breast cancer\n* lactation or breast feeding women\n* Paget-disease of the nipple\n* psychiatric disorder\n* increased radiosensitivity (e.g. collagen vascular disease)'}, 'identificationModule': {'nctId': 'NCT02003560', 'acronym': 'APERT', 'briefTitle': 'Accelerated Partial Breast Irradiation With 3D-CRT and IMRT', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Oncology, Hungary'}, 'officialTitle': 'Accelerated Partial Breast Irradiation After Breast Conserving Surgery for Low-risk Invasive Breast Cancer: 3D Conformal Radiotherapy (3D-CRT) and Intensity Modulated Radiotherapy (IMRT) - Prospective Phase II Study', 'orgStudyIdInfo': {'id': 'NIO-APERT_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accelerated partial breast irradiation', 'description': 'Accelerated partial breast irradiation delivered by 3 dimensional conformal radiotherapy or intensity modulated radiotherapy', 'interventionNames': ['Radiation: accelerated partial breast irradiation']}], 'interventions': [{'name': 'accelerated partial breast irradiation', 'type': 'RADIATION', 'description': '9 x 4.1 Gy accelerated partial breast irradiation delivered by 3D-CRT or IMRT over 5 consecutive days, using twice-a-day fractionation.', 'armGroupLabels': ['Accelerated partial breast irradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H-1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'National Institute of Oncology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Csaba Polgár, MD, PhD, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'National Institute of Oncology'}, {'name': 'Norbert Mészáros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Oncology, Hungary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Csaba Polgár', 'investigatorAffiliation': 'National Institute of Oncology, Hungary'}}}}