[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589260":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":43,"locations":52,"responsibleParty":76,"collaborators":30,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":30,"enrollmentInfo":88,"targetDuration":30,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":55,"whyStopped":30,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Fondazione del Piemonte per l'Oncologia","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Sparing Approach","EXPERIMENTAL","Group 1 - Patients with high-risk pT1cN0M0 cancerized adenoma, diagnosed through histological analysis following Endoscopic Resection (ER) or Local Excision (LE).\n\nFor patients classified as \"high-risk\" pT1 at final pathology, an experimental sparing strategy is proposed, consisting of experimental chemoradiotherapy (spCRT) followed by a Watch and Wait (W\\&W) approach (also referred to as Organ-Sparing Approach, OSA), in selected cases.",[13],"Procedure: Sparing Approach",{"label":15,"type":10,"description":16,"interventionNames":17},"Experimental Chemoradiotherapy: A Path to Conservative Treatment","Group 2 - Patients with cT2N0 tumors, typically candidates for upfront radical rectal resection. An alternative, non-operative approach is proposed based on experimental chemoradiotherapy (spCRT).\n\nAccording to current literature, the pathologic Complete Response (pCR) rate following CRT significantly exceeds the 25% commonly reported for intermediate to advanced rectal tumors. Clinical Complete Response (cCR) or clinical Minimal Residual disease (cMR) will be assessed through multidisciplinary, high-resolution restaging, including:\n\nPelvic Magnetic Resonance Imaging (MRI) Positron Emission Tomography (PET) Thoraco-abdominal Computed Tomography (CT) Endorectal Ultrasound (ERUS) Rectoscopy\n\nIn patients achieving cCR or cMR, a Watch \\& Wait (W\\&W) strategy or Local Excision\u002FTransanal Minimally Invasive Surgery (LE\u002FTAMIS) may be proposed to avoid the physical and psychological burden of major surgery. An intensive follow-up protocol will be implemented.",[18],"Procedure: experimental chemoradiotherapy",{"label":20,"type":21,"description":22,"interventionNames":23},"tandard Chemotherapy Approach: Restaging for Conservative Surgery","ACTIVE_COMPARATOR","Group 3 - Patients with cT3-4, N+, CRM-positive, or EMVI-positive tumors will receive standard chemoradiotherapy (stCRT) as the initial treatment.\n\nPatients achieving cCR or cMR at restaging will be evaluated for organ-sparing strategies, including Watch \\& Wait (W\\&W) or LE\u002FTAMIS, in accordance with existing multicenter clinical research protocols. In cases where a conservative approach is not feasible, standard surgical treatment will follow.",[24],"Procedure: Standard Chemotherapy",[26,31,35],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Accurate staging with Pelvic MRI, CT scan, PET total body have to be performed before local excision in order to exclude false positive mesorectal lymph nodes. Subsequent Wait and See (W\\&S) approach could be proposed.",[9],null,{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"experimental chemoradiotherapy","Participants with cT2N0 rectal tumors are typically candidates for upfront surgical resection. The investigators propose an alternative approach based on experimental chemoradiotherapy (spCRT). Literature suggests that pathologic complete response (pCR) rates after CRT are significantly higher than the 25% described for intermediate-advanced tumors. The investigators will assess clinical complete response (cCR) or complete metabolic response (cMR) through a multidisciplinary restaging process, including MRI, PET, thorax-abdomen CT scan, ERUS, and rectoscopy. In participants achieving cCR or cMR, a Watch and Wait (W\\&S) strategy or Local Excision\u002FTransanal Minimally Invasive Surgery (LE\u002FTAMIS) may be proposed to avoid the physical and psychological consequences of major surgery, followed by a rigorous surveillance program.",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Standard Chemotherapy","Tumors will be initially treated with standard CRT (stCRT). Patients who reach cCR-cMR at restaging they are already candidates to sparing approaches with W\\&S\u002FLE\u002FTAMIS according to Multicentric Resarch Study Protocol",[20],[40],{"name":41,"affiliation":5,"role":42},"Felice Borghi, MD","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":48},"Alfredo Mellano, MD","CONTACT","+390119933445","alfredo.mellano@ircc.it",{"name":50,"role":46,"phone":30,"phoneExt":30,"email":51},"Annamaria Nuzzo, PHD","annamaria.nuzzo@ircc.it",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment","RECRUITING","Candiolo","Turin","10060","Italy","IT",{"type":62,"coordinates":63},"Point",[64,65],7.59812,44.95858,{"lat":65,"lon":64},[68,71,72,74],{"name":45,"role":46,"phone":69,"phoneExt":70,"email":48},"011993","3445",{"name":41,"role":42,"phone":30,"phoneExt":30,"email":30},{"name":45,"role":73,"phone":30,"phoneExt":30,"email":30},"SUB_INVESTIGATOR",{"name":75,"role":73,"phone":30,"phoneExt":30,"email":30},"Manuela Robella, MD",{"type":77,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100589260","a-global-integrated-personalized-stage-related-multimodal-therapeutic-approach-for-rectal-adenocarcinoma-based-on-organ-sparing-and-mininvasivity-100589260",false,"NCT06952101","A Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity","INTERPRETE: a Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity","INTERPRETE","Inclusion Criteria:\n\n* Patients aged ≥18 yrs old\n* Patients able to sign the informed consent\n* Patients with High Risk pT1 rectal adenocarcinoma endoscopically excised\n* Patients with cT2-3aN0 rectal adenocarcinoma who has complete\u002Fmajor response to EXPERIMENTAL CRT\n* Patients with cT3b4N0-1 rectal adenocarcinoma who has complete\u002Fmajor response to STANDARD CRT\n\nExclusion Criteria:\n\n* cT2-4 any NM0 who don't reach cCR or cMR after experimental\u002Fstandard CRT\n* Pregnancy","ALL","18 Years",{"count":89,"type":90},200,"ESTIMATED","INTERVENTIONAL",[93],"NA","A phase II, single-center, non-profit, interventional study on patients affected by rectal adenocarcinoma. Patients will be stratified into three groups based on pre-treatment clinical stage. The study investigates and may propose a comprehensive, stage-specific, multimodal approach to rectal adenocarcinoma, with a focus on organ preservation even in early stages (cT1-2N0). When organ-sparing strategies are not feasible, the approach prioritizes minimally invasive techniques (laparoscopic and robotic) to reduce the physical, psychological, and quality-of-life impact on patients.",[96,97],"Rectal Adenocarcinoma","Non Metastatic",[96,99,100,101],"mininvasivity","organ sparing","surgical rectal resection","2026-03-03",{"date":104,"type":105},"2026-03-05","ACTUAL",{"date":107,"type":105},"2024-04-30",{"date":109,"type":90},"2030-12-31",{"name":5,"class":6},1]