[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638157":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":54,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":80,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"A single arm of patients will be treated","EXPERIMENTAL","A single arm of patients with locally advanced rectal cancer will be treated with preoperative radiochemotherapy.",[13],"Radiation: Preoperative, adaptive radiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Preoperative, adaptive radiotherapy","Preoperative radiotherapy will consist of 18 fractions to the mesorectum and regional lymph nodes. Halfway through the radiotherapy treatment, patients will undergo a second simulation MRI scan, from which a radiomic index called ERI\\_TCP will be calculated:\n\nERI\\_TCP=-ln\\[(1-(Vmid\u002FVpre)\\]Vpre where Vpre is the volume of the rectal tumor pre-therapy, Vmid is the volume of the residual tumor still visible in the MR images intermediate to RT. This index is able to discriminate patients with a good probability of pathologic complete response (ERI\\_TCP\\\u003C32.6) and exclude patients with zero probability of pathologic complete response (ERI\\_TCP\\>32.6). Patients with a good probability of response (41% in our experience) will receive a simultaneous boost delivered in the last 6 fractions to the residual tumor still visible in the intermediate MRI images (adaptive RT).\n\nConcomitant chemotherapy consists of Oxaliplatin 85 mg\u002Fm2 delivered on days -14, 0, +14, and Capecitabine 825 mg\u002Fm2 twice daily or les",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Nadia Di Muzio, Professor","Radiation Oncology Department","STUDY_DIRECTOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Paolo Passoni, Doctor","CONTACT","+39 02 26437643","passoni.paolo@hsr.it",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Miriam Torrisi, Doctor","+39 02 26438146","torrisi.miriam@hsr.it",[37],{"facility":38,"status":20,"city":39,"state":20,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"I.R.C.C.S. San Raffaele Hospital","Milan","20132","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],9.18951,45.46427,{"lat":47,"lon":46},[50,51,52],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},{"name":33,"role":53,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Paolo Passoni","Dr.","100638157","preoperative-adaptive-radiotherapy-concomitant-to-chemotherapy-for-rectal-adenocarcinoma-adaptive-rectal-cancer-trial-02-100638157",false,"NCT07580027","Preoperative, Adaptive Radiotherapy Concomitant to Chemotherapy for Rectal Adenocarcinoma (Adaptive Rectal Cancer Trial 02)","Preoperative, Adaptive Radiotherapy Concomitant to Chemotherapy for Rectal Adenocarcinoma (Adaptive Rectal Cancer Trial 02). An Interventional Study.","Inclusion Criteria:\n\nInitial phase (standard phase). These criteria represent the conditions for which preoperative chemoradiotherapy treatment for rectal cancer is clinically indicated\n\n1. Histologically confirmed rectal adenocarcinoma\n2. Microsatellite status: stable\n3. Stage T2N0 if lower rectal lesions are candidates for subsequent intersphincteric resection or abdominoperineal amputation with permanent colostomy\n4. Stage T3-T4N0 or any T with positive lymph nodes\n5. Lower margin of lesion no more than 12 cm from anal verge Adaptive radiotherapy phase (experimental phase)\n6. ERI\\_TCP \\\u003C 32.6 calculated as follows: ERITCP=-ln\\[(1-(Vmid\u002FVpre)\\]Vpre where Vpre is the volume of the rectal tumor pre-therapy, Vmid is the volume of the residual tumor still visible in the images of the MR intermediate to RT)\n7. Lower margin of rectal lesion at least 1 cm from surgical resection line on images of the intermediate smc MRI\n8. ECOG (Eastern Cooperative Oncology Group) Performance Status ≤ 2\n9. Age: 18-80 years\n10. Written informed consent\n\nExclusion Criteria:\n\n1. Distant metastases\n2. Previous cancer excluding non-melanoma skin cancer diagnosed less than 5 years before rectal cancer appearance\n3. Previous chemotherapy or radiotherapy to the pelvis\n4. Contraindications to radiotherapy: active ulcerative colitis\n5. Contraindications to chemotherapy: NE\\\u003C1.5x10\u002FL, Plt \\\u003C 100x10\u002FL), creatinine \\>1,5mg\u002Fdl, bilirubin \\> 2mg\u002Fdl, AST\u002FALT \\> 3x normal upper limit, significant cardiac disease, peripheral neuropathy.\n6. Pregnancy\n7. Breastfeeding","ALL","18 Years","80 Years",{"count":69,"type":70},33,"ESTIMATED","INTERVENTIONAL",[73],"NA","The aim of this clinical study is to increase the rate of pathological responses up to 70% by means of improved patient selection operated by a radiobiological index called ERI\\_TCP and by an increase in the dose of radiotherapy in the final concomitant boost of preoperative radiochemotherapy treatment for rectal adenocarcinoma.",[76],"Locally Advanced Rectal Carcinoma",[78,79],"adaptive radiotherapy","preoperative radiotherapy","NOT_YET_RECRUITING","2026-05-05",{"date":83,"type":84},"2026-05-12","ACTUAL",{"date":86,"type":70},"2026-04-30",{"date":88,"type":70},"2029-04-30",{"name":5,"class":6},1]