[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443481":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":34,"studyPopulation":27,"armGroups":35,"interventions":48,"overallOfficials":55,"centralContacts":59,"locations":69,"responsibleParty":101,"collaborators":27,"id":103,"slug":27,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":27,"enrollmentInfo":112,"targetDuration":27,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":72,"whyStopped":27,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Institute of Oncology Ljubljana","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"complete remission rate","The proportion of complete responses will be defined as the sum of the proportions of pCR in operated patients and cCR in non-operated patients.","2 weeks after completiton of TNT",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Overall survival","time from randomization to death","after 3 years of follow-up",{"measure":19,"description":20,"timeFrame":17},"Survival without recurrence of the disease","time from the end of treatment (in the case of cCR) or from radical surgery to death or recurrence of the disease - whichever comes first.",{"measure":22,"description":23,"timeFrame":17},"Disease free survival","the time from the end of treatment (in the case of cCR) or surgery to the recurrence of disease, the onset of new cancer, death from cancer or other causes",{"measure":25,"description":26,"timeFrame":17},"local control","the time from the end of the treatment (in the case of cCR) or surgery to local recurrence",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","FACTORIAL","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE","International recommendations for the treatment of LARC with a high risk of disease recurrence are inconsistent, regarding TNT. In Germain randomised study more pCR were achieved with consolidation chemotherapy. We will compare our standard approach (induction plus consolidation CT) with consolidation CT.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"consolidation chemotherapy","EXPERIMENTAL","chemoradiation: intensity-modulated irradiation technique with simultaneous integrated boost to the tumor (IMRT-SIB) or with volumetric modulated arc therapy (VMAT) with simultaneous integrated boost (VMAT-SIB) to the total tumor dose of 46.2 Gy in T1-3 tumors and 48.4 Gy in T4 tumors in 22 fractions with concomitant CT with capecitabine (dosage: 825 mg \u002F m2 \u002F 12 h per os continuously from the first to the last day of irradiation).\n\n6 cycles of CAPOX chemotherapy. One cycle of CAPOX CT lasts 3 weeks and consists of capecitabine 1000 mg \u002F m2 \u002F 12h per os for 1-14 days and oxaliplatin 130 mg \u002F m2 intravenously in a two-hour infusion on day 1.",[41],"Other: consolidation chemotherapy",{"label":43,"type":44,"description":45,"interventionNames":46},"induction chemotherapy","ACTIVE_COMPARATOR","4 cycles of induction CAPOX chemotherapy. One cycle of CAPOX CT lasts 3 weeks and consists of capecitabine 1000 mg \u002F m2 \u002F 12h per os for 1-14 days and oxaliplatin 130 mg \u002F m2 intravenously in a two-hour infusion on day 1.\n\nChemoradiation:intensity-modulated irradiation technique with simultaneous integrated boost to the tumor (IMRT-SIB) or with volumetric modulated arc therapy (VMAT) with simultaneous integrated boost (VMAT-SIB) to the total tumor dose of 46.2 Gy in T1-3 tumors and 48.4 Gy in T4 tumors in 22 fractions with concomitant CT with capecitabine (dosage: 825 mg \u002F m2 \u002F 12 h per os continuously from the first to the last day of irradiation).\n\n2 cycles of consolidation CAPOX chemotherapy.",[47],"Other: induction chemotherapy",[49,52],{"type":6,"name":37,"description":50,"armGroupLabels":51,"otherNames":27},"6 cycles CAPOX after chemoradiotherapy",[37],{"type":6,"name":43,"description":53,"armGroupLabels":54,"otherNames":27},"4 cycles CAPOX before and 2 cycles CAPOX after chemoradiotherapy",[43],[56],{"name":57,"affiliation":5,"role":58},"Vaneja Velenik, PD","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":27,"email":64},"Vaneja Velenik, PhD","CONTACT","+386 15879297","vvelenik@onko-i.si",{"name":66,"role":62,"phone":67,"phoneExt":27,"email":68},"Miha Orazem, MD","+386 58792941","morazem@oko-i.si",[70],{"facility":71,"status":72,"city":73,"state":27,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Institute of Oncology","RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":78,"coordinates":79},"Point",[80,81],14.50513,46.05108,{"lat":81,"lon":80},[84,86,89,91,94,96,98,100],{"name":61,"role":62,"phone":85,"phoneExt":27,"email":64},"+386 1 5879 297",{"name":66,"role":62,"phone":87,"phoneExt":27,"email":88},"+386 1 5879 294","morazem@onko-i.si",{"name":90,"role":58,"phone":27,"phoneExt":27,"email":27},"Vaneja Velenik, PhD, MD",{"name":92,"role":93,"phone":27,"phoneExt":27,"email":27},"Franc Anderluh, MD","SUB_INVESTIGATOR",{"name":95,"role":93,"phone":27,"phoneExt":27,"email":27},"Ajra Secerov ErmencOblak, MD",{"name":97,"role":93,"phone":27,"phoneExt":27,"email":27},"Janja Ocvirk, PhD, MD",{"name":99,"role":93,"phone":27,"phoneExt":27,"email":27},"Erik Brecelj, PhD, MD",{"name":66,"role":93,"phone":27,"phoneExt":27,"email":27},{"type":58,"investigatorFullName":102,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Violeta Kaluza","100443481",false,"NCT05054959","Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence","Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Localy Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)","ICONA","Inclusion Criteria:- histologically proven rectal adenocarcinoma\n\n* no distant metastases on CT scan (M0 disease)\n* at least one high risk factor for disease recurrence identified on MR imaging:\n\n  * T4 tumor (cT4)\n  * N2 disease (cN2)\n  * extramural venous invasion (cEMVI+)\n  * positive lateral lymph nodes\n  * distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+)\n* capacity for informed consent\n* willingness to attend regular check-ups during and after treatment\n\nExclusion Criteria:history of previous irradiation in the pelvic area\n\n* absolute contraindications for MR imaging\n* distant metastases cannot be reliably excluded\n* synchronous cancer\n* chronic inflammatory bowel disease","ALL","18 Years",{"count":113,"type":114},62,"ESTIMATED","INTERVENTIONAL",[117],"PHASE2","The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence",[120],"Locally Advanced Rectal Cancer",[122,123,43,37],"rectal cancer","total neoadjuvant therapy","2021-09-19",{"date":126,"type":127},"2021-09-23","ACTUAL",{"date":129,"type":127},"2021-06-24",{"date":131,"type":114},"2027-12-31",{"name":5,"class":6},1]