[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603267":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":27,"studyPopulation":20,"armGroups":28,"interventions":35,"overallOfficials":40,"centralContacts":47,"locations":20,"responsibleParty":54,"collaborators":20,"id":56,"slug":20,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":77,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":20},{"fullName":5,"class":6},"Clinica Universidad de Navarra, Universidad de Navarra","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Total Mesorectal Excision (TME)-free survival","To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.","5-years",[14,17],{"measure":15,"description":16,"timeFrame":12},"Proctitis\u002FRectal Bleeding","To achieve a CTCAE v5 grade 2-3 proctitis of less than 10% and grade 2-3 rectal bleeding rate of \\\u003C2% at 2 years.",{"measure":18,"description":19,"timeFrame":12},"Fecal Continence","To achieve a Wexner Continence score of at least 90% over baseline at 2 years.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"NA","SINGLE_GROUP","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE","HYPOTHESIS\n\nThe implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a TNT Program renders improved TME-free rates due to the better visualization and online dose-adaptation of the Gross Tumor Volume (GTV).\n\nRationale In the radiation setting, MRI provides superior soft tissue contrast compared to standard onboard X-ray imaging improving inter- and intra- observer delineation variation. MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen. This is especially important in rectal cancer where the rectum is subject to interfractional position changes, volume shrinkage and intrafractional shape and size variation due to the variability in rectal filling.\n\nPrimary Objectives\n\nA. To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.\n\nB. To achieve a CTCAE v5 grade 2-3 proctitis of less than 10% and grade 2-3 rectal bleeding rate of \\\u003C2% at 2 years.\n\nC. To achieve a Wexner Continence score of at least 90% over baseline at 2 years.\n\nSecondary Objectives\n\nA. Determination of blood and urine biomarkers of treatment response and toxicity .\n\nB. Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of rectal functionality with the Wexner Continence Score.",[29],{"label":30,"type":31,"description":32,"interventionNames":33},"Dose Escalation Phase","EXPERIMENTAL","Dose Escalation MR-guided TNT",[34],"Radiation: MR-Guided Irradiation",[36],{"type":37,"name":38,"description":38,"armGroupLabels":39,"otherNames":20},"RADIATION","MR-Guided Irradiation",[30],[41,45],{"name":42,"affiliation":43,"role":44},"Rafael Martínez-Monge, M.D.","Clínica Universidad de Navarra","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":43,"role":44},"Luis Fuertes, M.D.",[48],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Beatriz Ramos Aguirre, M.S.","CONTACT","+34 948255400","2772","ucicec@unav.es",{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100603267",false,"NCT07134296","Magnetic Resonance Imaging (MRI)-Guided Rectal Cancer Preservation Program","MRI-guided Rectal Cancer Preservation Program","Inclusion Criteria:\n\n* Patients aged 18 or older with primary Stage II (T3-4, N0) or Stage III (any T, N1-2) biopsy-proven rectal cancer\n* No prior radiation therapy to the target areas;\n* ECOG 0-2 with medical status not contraindicating treatment with radical intent including TNT and TME (if required) and with basal laboratory values as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n  * Platelets ≥ 50,000 cells\u002Fmm3.\n  * Hemoglobin ≥ 8.0 g\u002Fdl.\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 4 x upper limit of normal.\n  * Total bilirubin \\\u003C 2 x upper normal mg\u002FdL.\n  * Alkaline phosphatase \\\u003C 4 x upper limit of normal.\n\nExclusion Criteria:\n\n* Patient unable to undergo an MRI examination","ALL","18 Years","80 Years",{"count":66,"type":67},32,"ESTIMATED","INTERVENTIONAL",[22],"The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of rectal preservation",[72],"Rectal Cancer",[74,75,76],"TNT","MRI-guided Irradiation","Rectal Preservation","NOT_YET_RECRUITING","2025-08-20",{"date":80,"type":81},"2025-08-21","ACTUAL",{"date":83,"type":67},"2025-10-01",{"date":85,"type":67},"2030-06-30",{"name":5,"class":6}]