Nctid:
NCT06224244
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001943", "term"=>"Breast Neoplasms"}], "ancestors"=>[{"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000001941", "term"=>"Breast Diseases"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "asFound"=>"Breast Cancer", "relevance"=>"HIGH"}, {"id"=>"M5218", "name"=>"Breast Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Two test groups. A Simultaneous integrated boost to 40 Gy (SIB 40): 34 Gy to the ipsilateral breast with concomitant boost to 40 Gy to the tumor bed. A Simultaneous integrated boost to 43 Gy (SIB 43): 34 Gy to the ipsilateral breast with concomitant boost to 43 Gy to the tumor bed"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>180}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2022-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale", "timeFrame"=>"From the end of treatment at 3 years", "description"=>"Incidence of grade 2-3 late toxicity in terms of skin toxicity"}], "secondaryOutcomes"=>[{"measure"=>"Incidence of local tumor relapse, distant metastasis and assessment of overall survival", "timeFrame"=>"Time from the date of the diagnosis of primary breast cancer to the date of diagnosis of local relapse, distant metastasis or death from any cause, assessed up to 60 months", "description"=>"Identification of local tumor relapse in the breast parenchyma within boost volume, breast parenchyma within volume receiving 34Gy; identification of distant metastasis and analysis of overall survival"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Breast cancer", "simultaneous integrated boost", "hypofractionated radiotherapy", "whole breast radiotherapy"], "conditions"=>["Breast Neoplasms", "Breast Cancer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"37302395", "type"=>"RESULT", "citation"=>"Coles CE, Haviland JS, Kirby AM, Griffin CL, Sydenham MA, Titley JC, Bhattacharya I, Brunt AM, Chan HYC, Donovan EM, Eaton DJ, Emson M, Hopwood P, Jefford ML, Lightowlers SV, Sawyer EJ, Syndikus I, Tsang YM, Twyman NI, Yarnold JR, Bliss JM; IMPORT Trial Management Group. Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): a multicentre, phase 3, non-inferiority, open-label, randomised controlled trial. Lancet. 2023 Jun 24;401(10394):2124-2137. doi: 10.1016/S0140-6736(23)00619-0. Epub 2023 Jun 8."}, {"pmid"=>"29282078", "type"=>"RESULT", "citation"=>"Pinnaro P, Giordano C, Farneti A, Faiella A, Iaccarino G, Landoni V, Giannarelli D, Vici P, Strigari L, Sanguineti G. Short course hypofractionated whole breast irradiation after conservative surgery: a single institution phase II study. J Exp Clin Cancer Res. 2017 Dec 27;36(1):191. doi: 10.1186/s13046-017-0640-z."}, {"pmid"=>"20100335", "type"=>"RESULT", "citation"=>"Pinnaro P, Soriani A, Landoni V, Giordano C, Papale M, Marsella A, Marucci L, Arcangeli G, Strigari L. Accelerated hypofractionated radiotherapy as adjuvant regimen after conserving surgery for early breast cancer: interim report of toxicity after a minimum follow up of 3 years. J Exp Clin Cancer Res. 2010 Jan 25;29(1):9. doi: 10.1186/1756-9966-29-9."}]}, "descriptionModule"=>{"briefSummary"=>"This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer", "detailedDescription"=>"Patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Histologically proven invasive or in situ unifocal adenocarcinoma of the breast\n* Breast conserving surgery\n* Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells \\[i+\\] allowed) pN1mic, M0 stage\n* Postoperative negative (no ink) final surgical margins\n* Patient requires a whole breast radiotherapy plus a tumor bed boost\n* Female patients aged ≥ 18 years of any menopausal status\n* ECOG performance status 0-2\n\nExclusion Criteria:\n\n* Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free\n* Mastectomy\n* Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded)\n* Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma\n* Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder\n* Pregnant or lactating patients\n* Presence of ipsilateral breast implant\n* Prior breast or thoracic radiotherapy for any condition"}, "identificationModule"=>{"nctId"=>"NCT06224244", "acronym"=>"ESIBIRE", "briefTitle"=>"External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"Regina Elena Cancer Institute"}, "officialTitle"=>"A Prospective Phase II Trial of an Accelerated Hypofractionated Radiotherapy Schedule With Risk-adapted Simultaneous Integrated Boost (HF-SIB) in Early Breast Cancer Patients Undergoing Breast Conserving Surgery", "orgStudyIdInfo"=>{"id"=>"1652/22"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Simultaneous integrated boost to 40 Gy (SIB 40)", "description"=>"Patients with the following clinico-pathological characteristics\n\n* pTis G3,\n* pT1 pN0/pN1mic, G1-G3 luminal biology or Her-2 positive", "interventionNames"=>["Radiation: Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Simultaneous integrated boost to 43 Gy (SIB 43)", "description"=>"Patients with the following clinico-pathological characteristics:\n\n* Triple negative disease,\n* pT2 pN0/pN1mic,\n* ≤ 50 years not Luminal A", "interventionNames"=>["Radiation: Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost"]}], "interventions"=>[{"name"=>"Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost", "type"=>"RADIATION", "otherNames"=>["SIB40"], "description"=>"Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy", "armGroupLabels"=>["Simultaneous integrated boost to 40 Gy (SIB 40)"]}, {"name"=>"Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost", "type"=>"RADIATION", "otherNames"=>["SIB43"], "description"=>"Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy", "armGroupLabels"=>["Simultaneous integrated boost to 43 Gy (SIB 43)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"00144", "city"=>"Rome", "state"=>"Lazio", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Silvia Takanen", "role"=>"CONTACT", "email"=>"silvia.takanen@ifo.it", "phone"=>"+39065266"}, {"name"=>"Silvia Takanen", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Regina Elena Cancer Institute", "geoPoint"=>{"lat"=>41.89193, "lon"=>12.51133}}], "centralContacts"=>[{"name"=>"Silvia Takanen", "role"=>"CONTACT", "email"=>"silvia.takanen@ifo.it", "phone"=>"+39065266"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Regina Elena Cancer Institute", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Silvia Takanen", "investigatorAffiliation"=>"Regina Elena Cancer Institute"}}}}
