Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-06 @ 5:30 AM
Study NCT ID:
NCT03710733
Status:
UNKNOWN
Last Update Posted:
2020-09-11
First Post:
2018-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following BCS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 185}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2018-07-07', 'studyFirstSubmitQcDate': '2018-10-16', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Breast Cosmetic Outcome', 'timeFrame': '1 year', 'description': 'Rate the qualities of the treated breast as compared with the untreated breast using European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction: Breast Questionnaire (Breast Q)', 'timeFrame': '1 year', 'description': 'Using Breast Questionnaire (Breast Q)'}, {'measure': 'Acute Toxicity (Breast Skin)', 'timeFrame': 'During treatment and up to 3 months after treatment', 'description': 'Using Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria'}, {'measure': 'Late Toxicity (Breast Skin, Heart, Lungs)', 'timeFrame': '1 year', 'description': 'Using Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiotherapy Side Effect']}, 'referencesModule': {'references': [{'pmid': '18356109', 'type': 'BACKGROUND', 'citation': "START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19."}, {'pmid': '18355913', 'type': 'BACKGROUND', 'citation': "START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19."}, {'pmid': '10820347', 'type': 'BACKGROUND', 'citation': 'Whelan TJ, Levine M, Julian J, Kirkbride P, Skingley P. The effects of radiation therapy on quality of life of women with breast carcinoma: results of a randomized trial. Ontario Clinical Oncology Group. Cancer. 2000 May 15;88(10):2260-6.'}, {'pmid': '20147717', 'type': 'BACKGROUND', 'citation': 'Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.'}, {'pmid': '17379440', 'type': 'BACKGROUND', 'citation': 'van der Laan HP, Dolsma WV, Maduro JH, Korevaar EW, Hollander M, Langendijk JA. Three-dimensional conformal simultaneously integrated boost technique for breast-conserving radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):1018-23. doi: 10.1016/j.ijrobp.2007.01.037. Epub 2007 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.', 'detailedDescription': 'This study is a prospective randomized non-inferiority trial of accelerated hypofractionated whole breast irradiation plus sequential boost versus concomitant boost after breast conservative surgery. It will be conducted on 124 patients who will be randomized using permuted blocks. The primary outcome measured is the cosmetic outcome, while secondary outcomes are patient satisfaction (using breast questionnaire), acute toxicity (using RTOG acute toxicity scoring criteria), and late toxicity (using RTOG late toxicity scoring criteria).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histopathologically proven breast cancer resected by lumpectomy\n* Female patient\n* Invasive breast cancer\n* Negative surgical margin\n* Age \\< or equal 50 years, or high-grade irrespective of age\n* Appropriate stage for protocol entry i.e. no metastasis\n* Performance Status 0-2\n* Hormone receptor status:\n\n 1. ER/PR Known\n 2. Borderline results are considered positive\n\nExclusion Criteria:\n\n* Metastatic patients\n* Paget's disease of nipple\n* Non-epithelial breast malignancy e.g. sarcoma, lymphoma\n* Unresected suspicious microcalcifications in the same or contralateral breast\n* Pregnant women\n* Inability to delineate lumpectomy cavity\n* Psychiatric or addictive disorders rendering treatment or follow-up difficult"}, 'identificationModule': {'nctId': 'NCT03710733', 'briefTitle': 'Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following BCS', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Randomized Prospective Study of Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following Breast Conservative Surgery', 'orgStudyIdInfo': {'id': '201617079.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sequential boost', 'description': 'Hypofractionated whole breast irradiation 40 Gy/15 fx (2.67 Gy/fx) plus sequential boost 10 Gy/4 fx (2.5 Gy/fx) to lumpectomy cavity', 'interventionNames': ['Radiation: Sequential boost']}, {'type': 'EXPERIMENTAL', 'label': 'Concomitant boost', 'description': 'Hypofractionated whole breast irradiation 40 Gy/15 fx (2.67 Gy/fx) plus concomitant boost 8 Gy/15 fx (0.53 Gy/fx) to lumpectomy cavity', 'interventionNames': ['Radiation: Concomitant boost']}], 'interventions': [{'name': 'Sequential boost', 'type': 'RADIATION', 'description': 'Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation', 'armGroupLabels': ['Sequential boost']}, {'name': 'Concomitant boost', 'type': 'RADIATION', 'description': 'Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation', 'armGroupLabels': ['Concomitant boost']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute, Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Medhat El Sebaie, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Cancer Institute, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Radiation Oncology', 'investigatorFullName': 'Rimoun Ramsis Anis Boutrus', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}