[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553780":3},{"organization":4,"armGroups":7,"interventions":45,"overallOfficials":91,"centralContacts":96,"locations":102,"responsibleParty":460,"collaborators":44,"id":462,"slug":463,"hasResults":464,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":44,"eligibilityCriteria":468,"healthyVolunteers":464,"sex":469,"minAge":470,"maxAge":44,"enrollmentInfo":471,"targetDuration":44,"studyType":474,"phases":475,"briefSummary":477,"conditions":478,"keywords":44,"overallStatus":105,"whyStopped":44,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":490},{"fullName":5,"class":6},"IFOM ETS - The AIRC Institute of Molecular Oncology","OTHER",[8,17,24,27,36,40],{"label":9,"type":10,"description":11,"interventionNames":12},"Trial-1 (ctDNA+) Strata-1 (MSS\u002FMMRp extendend RAS\u002FRAFmut) Standard Therapy","ACTIVE_COMPARATOR","CAPOX\u002FFOLFOX for 6 months or until toxicity",[13,14,15,16],"Drug: Oxaliplatin","Drug: Capecitabine","Drug: Folinic acid","Drug: Fluorouracil",{"label":18,"type":19,"description":20,"interventionNames":21},"Trial-1 (ctDNA+) Strata-1 (MSS\u002FMMRp extendend RAS\u002FRAFmut) Tailored Therapy","EXPERIMENTAL","CAPOX for 3 months with an interventional liquid biopsy at the end of the treatment. Patients still resulting ctDNA+ will be switched to a tailored therapy (FOLFIRI for RAS\u002FRAF-mutated and MGMT-positive tumors or TEMIRI for RAS\u002FRAF-mutated and MGMT-negative tumors) for 6 months or until toxicity. On the other hand, ctDNA- patients will continue CAPOX up to 3 months, and their ctDNA status will be re-assessed at the end of the treatment. Patients remaining ctDNA- will enter into follow-up, while patients resulting ctDNA+ will be switched to the tailored therapy.",[13,14,15,16,22,23],"Drug: Temozolomide","Drug: Irinotecan",{"label":25,"type":10,"description":11,"interventionNames":26},"Trial-1 (ctDNA+) Strata-2 (MSI-H\u002FMMRd & MSS\u002FMMRp extended RAS\u002FRAFwt) Standard Therapy",[13,14,15,16],{"label":28,"type":19,"description":29,"interventionNames":30},"Trial-1 (ctDNA+) Strata-2 (MSI-H\u002FMMRd & MSS\u002FMMRp extended RAS\u002FRAFwt) Tailored Therapy","Tailored therapy (nivolumab+ipilimumab for MSI-H\u002FMMRd: MSI-H\u002FMMRd tumors and MSS\u002FMMRp tumors with POLE mutations and a high TMB or trastuzumab + pertuzumab for MSS\u002FMMRp HER2-amplified tumors or panitumumab+folfox for MSS\u002FMMRp RAS\u002FRAF\u002FHER2 wild-type) for 3 months, at the end, the ctDNA status of patients will be reassessed to further guide their subsequent treatments. Patients still ctDNA+ at will be switched to standard therapy. On the other hand, patients undergoing seroconversion will continue the same therapy for 3 further months and will be then re-assessed at the end of the treatment. Patients resulting ctDNA- will enter into Follow-up, while patients resulting ctDNA+ will be switched to the standard therapy.",[31,32,33,34,35],"Drug: Nivolumab","Drug: Ipilimumab","Drug: Trastuzumab","Drug: Pertuzumab","Drug: Panitumumab",{"label":37,"type":10,"description":38,"interventionNames":39},"Trial-2 (ctDNA-) Standard Therapy","Chemotherapy regimen at prior declared physician choice (CAPE\u002FCAPOX\u002FFOLFOX\u002F5-FU±LV).",[13,14,15,16],{"label":41,"type":42,"description":43,"interventionNames":44},"Trial-2 (ctDNA-) Intensive Follow-up","NO_INTERVENTION","Intensive follow-up for 6 months (except for MSS Stage III High-risk patients which will be treated with CAPE).",null,[46,51,55,59,63,67,71,75,79,83,87],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":44},"DRUG","Oxaliplatin","Oxaliplatin is used as part of the chemotherapy regimens for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following ways:\n\nCAPOX Regimen: Oxaliplatin 130 mg\u002Fm² is given intravenously on day 1, in combination with capecitabine 1000 mg\u002Fm² taken orally twice daily on days 1-14 of each 21-day cycle.\n\nFOLFOX Regimen: Oxaliplatin 85 mg\u002Fm² is administered intravenously on day 1, alongside folinic acid 400 mg\u002Fm² and fluorouracil 400 mg\u002Fm² IV bolus, followed by 2400 mg\u002Fm² IV infusion over 46 hours, in each 14-day cycle.\n\nDosages are standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results, typically up to 6 months.",[9,18,25,37],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":44},"Capecitabine","Capecitabine is used as part of the chemotherapy regimens for patients with ctDNA+ and ctDNA- results in the SAGITTARIUS trial. It is administered in the following ways:\n\nCAPOX Regimen: Capecitabine 1000 mg\u002Fm² is taken orally twice daily on days 1-14 of each 21-day cycle, in combination with oxaliplatin 130 mg\u002Fm² given intravenously on day 1.\n\nCapecitabine Monotherapy for High-Risk ctDNA- Patients: Capecitabine 1250 mg\u002Fm² is taken orally twice daily on days 1-14 of each 21-day cycle for patients identified as high-risk but with negative ctDNA results.\n\nThe dosage of capecitabine is standardized, while the duration of treatment varies based on patient response and monitoring results, typically up to 6 months.",[9,18,25,37],{"type":47,"name":56,"description":57,"armGroupLabels":58,"otherNames":44},"Folinic acid","Folinic acid is used as part of the FOLFOX chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following way:\n\nFOLFOX Regimen: Folinic acid (leucovorin) 400 mg\u002Fm² is given intravenously on day 1, in combination with oxaliplatin 85 mg\u002Fm² IV on day 1 and fluorouracil 400 mg\u002Fm² IV bolus followed by 2400 mg\u002Fm² IV infusion over 46 hours, in each 14-day cycle.\n\nThe dosage of folinic acid is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results, typically up to 6 months.",[9,18,25,37],{"type":47,"name":60,"description":61,"armGroupLabels":62,"otherNames":44},"Fluorouracil","Fluorouracil is used as part of the FOLFOX chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following way:\n\nFOLFOX Regimen: Fluorouracil 400 mg\u002Fm² is given as an intravenous (IV) bolus on day 1, followed by 2400 mg\u002Fm² as a continuous IV infusion over 46 hours, in combination with folinic acid (leucovorin) 400 mg\u002Fm² IV on day 1 and oxaliplatin 85 mg\u002Fm² IV on day 1. This regimen is repeated every 14 days.\n\nThe dosage of fluorouracil is standardized, while the duration of treatment is typically up to 6 months, adjusted based on patient response and liquid biopsy results.",[9,18,25,37],{"type":47,"name":64,"description":65,"armGroupLabels":66,"otherNames":44},"Temozolomide","Temozolomide is used as part of the tailored chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial, specifically for those with MGMT-negative tumors. It is administered in the following way:\n\nTEMIRI Regimen: Temozolomide 150-200 mg\u002Fm² is taken orally once daily on days 1-5 of each 28-day cycle, in combination with irinotecan 250 mg\u002Fm² administered intravenously on day 1 of each cycle.\n\nThe dosage of temozolomide is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.",[18],{"type":47,"name":68,"description":69,"armGroupLabels":70,"otherNames":44},"Irinotecan","Irinotecan is used as part of the tailored chemotherapy regimen for patients with ctDNA+ results in the SAGITTARIUS trial. It is administered in the following ways:\n\nTEMIRI Regimen: Irinotecan 250 mg\u002Fm² is administered intravenously on day 1 of each 28-day cycle, in combination with temozolomide 150-200 mg\u002Fm² taken orally once daily on days 1-5.\n\nFOLFIRI Regimen: Irinotecan 180 mg\u002Fm² is given intravenously on day 1, in combination with folinic acid (leucovorin) 400 mg\u002Fm² IV, fluorouracil 400 mg\u002Fm² IV bolus, followed by 2400 mg\u002Fm² IV infusion over 46 hours, in each 14-day cycle.\n\nThe dosage of irinotecan is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.",[18],{"type":47,"name":72,"description":73,"armGroupLabels":74,"otherNames":44},"Nivolumab","Nivolumab is used as part of the tailored immunotherapy regimen for patients with ctDNA+ results, specifically for those with MSI-H\u002FMMRd tumors in the SAGITTARIUS trial. It is administered in the following way:\n\nNivolumab: 3 mg\u002Fkg is given intravenously every 2 weeks. This dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.",[28],{"type":47,"name":76,"description":77,"armGroupLabels":78,"otherNames":44},"Ipilimumab","Ipilimumab is used as part of the tailored immunotherapy regimen for patients with ctDNA+ results, specifically for those with MSI-H\u002FMMRd tumors in the SAGITTARIUS trial. It is administered in the following way:\n\nIpilimumab: 1 mg\u002Fkg is given intravenously every 6 weeks. This dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.",[28],{"type":47,"name":80,"description":81,"armGroupLabels":82,"otherNames":44},"Trastuzumab","Trastuzumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with HER2-amplified tumors in the SAGITTARIUS trial. It is administered in the following way:\n\nTrastuzumab: 8 mg\u002Fkg as an initial intravenous (IV) loading dose, followed by 6 mg\u002Fkg IV every 3 weeks.\n\nThe dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.",[28],{"type":47,"name":84,"description":85,"armGroupLabels":86,"otherNames":44},"Pertuzumab","Pertuzumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with HER2-amplified tumors in the SAGITTARIUS trial. It is administered in the following way:\n\nPertuzumab: 840 mg as an initial intravenous (IV) loading dose, followed by 420 mg IV every 3 weeks.\n\nThe dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.",[28],{"type":47,"name":88,"description":89,"armGroupLabels":90,"otherNames":44},"Panitumumab","Panitumumab is used as part of the tailored targeted therapy regimen for patients with ctDNA+ results, specifically for those with multiple wild-type tumors (MSS\u002FMMRp extended RAS\u002FRAF wild-type) in the SAGITTARIUS trial. It is administered in the following way:\n\nPanitumumab: 6 mg\u002Fkg is given intravenously every 2 weeks. The dosage is standardized, while the duration of treatment can be adjusted based on patient response and liquid biopsy results.",[28],[92],{"name":93,"affiliation":94,"role":95},"Clara Montagut","Hospital del Mar","PRINCIPAL_INVESTIGATOR",[97],{"name":98,"role":99,"phone":100,"phoneExt":44,"email":101},"Silvia Marsoni","CONTACT","+39 02.574303862","sagittarius@ifom.eu",[103,121,137,151,165,180,194,207,221,235,249,263,277,292,307,318,332,343,354,365,379,393,407,421,435,446],{"facility":104,"status":105,"city":106,"state":44,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Charité - Universitätsmedizin Berlin","RECRUITING","Berlin","10117","Germany","DE",{"type":111,"coordinates":112},"Point",[113,114],13.41053,52.52437,{"lat":114,"lon":113},[117],{"name":118,"role":99,"phone":119,"phoneExt":44,"email":120},"Sebastian Stintzing, MD","+49030450613132","sebastian.stintzing@charite.de",{"facility":122,"status":105,"city":123,"state":123,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Azienda Sanitaria Locale di Biella","Biella","13875","Italy","IT",{"type":111,"coordinates":128},[129,130],8.05796,45.56304,{"lat":130,"lon":129},[133],{"name":134,"role":99,"phone":135,"phoneExt":44,"email":136},"Francesco Leone, MD","+3901515157503","francesco.leone@aslbi.piemonte.it",{"facility":138,"status":105,"city":139,"state":139,"zip":140,"country":125,"countryCode":126,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Fondazione Poliambulanza","Brescia","25124",{"type":111,"coordinates":142},[143,144],10.21472,45.53558,{"lat":144,"lon":143},[147],{"name":148,"role":99,"phone":149,"phoneExt":44,"email":150},"Michela Libertini, MD","+390303515557","michela.libertini@poliambulanza.it",{"facility":152,"status":105,"city":153,"state":153,"zip":154,"country":125,"countryCode":126,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Azienda Ospedaliera Universitaria San Martino","Genova","16132",{"type":111,"coordinates":156},[157,158],11.87211,45.21604,{"lat":158,"lon":157},[161],{"name":162,"role":99,"phone":163,"phoneExt":44,"email":164},"Maria Stefania Sciallero, MD","+390105553302","stefania.sciallero@hsanmartino.it",{"facility":166,"status":105,"city":167,"state":168,"zip":169,"country":125,"countryCode":126,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Istituto Europeo di Oncologia","Milan","Milano","20141",{"type":111,"coordinates":171},[172,173],12.59836,42.78235,{"lat":173,"lon":172},[176],{"name":177,"role":99,"phone":178,"phoneExt":44,"email":179},"Maria Giulia Zampino, MD","+390257489406","maria.zampino@ieo.it",{"facility":181,"status":105,"city":182,"state":168,"zip":183,"country":125,"countryCode":126,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Istituto Clinico Humanitas","Rozzano","20089",{"type":111,"coordinates":185},[186,187],9.1559,45.38193,{"lat":187,"lon":186},[190],{"name":191,"role":99,"phone":192,"phoneExt":44,"email":193},"Armando Santoro, MD","+390282244080","armando.santoro@hunimed.eu",{"facility":195,"status":105,"city":167,"state":167,"zip":196,"country":125,"countryCode":126,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Ospedale Niguarda","20162",{"type":111,"coordinates":198},[199,200],9.18951,45.46427,{"lat":200,"lon":199},[203],{"name":204,"role":99,"phone":205,"phoneExt":44,"email":206},"Salvatore Siena, MD","+390264442291","salvatore.siena@ospedaleniguarda.it",{"facility":208,"status":105,"city":209,"state":209,"zip":210,"country":125,"countryCode":126,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Ospedale Maggiore di Novara","Novara","28100",{"type":111,"coordinates":212},[213,214],8.62118,45.44694,{"lat":214,"lon":213},[217],{"name":218,"role":99,"phone":219,"phoneExt":44,"email":220},"Alessandra Gennari, MD","+3903213733822","alessandra.gennari@maggioreosp.novara.it",{"facility":222,"status":105,"city":223,"state":223,"zip":224,"country":125,"countryCode":126,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Azienda Ospedaliera Universitaria di Parma","Parma","43126",{"type":111,"coordinates":226},[227,228],10.32618,44.79935,{"lat":228,"lon":227},[231],{"name":232,"role":99,"phone":233,"phoneExt":44,"email":234},"Francesca Negri, MD","+390521703749","fnegri@ao.pr.it",{"facility":236,"status":105,"city":237,"state":237,"zip":238,"country":125,"countryCode":126,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"Ospedale Santa Maria della Misericordia","Perugia","06129",{"type":111,"coordinates":240},[241,242],12.38878,43.1122,{"lat":242,"lon":241},[245],{"name":246,"role":99,"phone":247,"phoneExt":44,"email":248},"Mario Mandalà, MD","+390755784205","mario.mandala@unipg.it",{"facility":250,"status":105,"city":251,"state":251,"zip":252,"country":125,"countryCode":126,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Azienda Unità Sanitaria Locale della Romagna","Ravenna","48121",{"type":111,"coordinates":254},[255,256],12.20121,44.41344,{"lat":256,"lon":255},[259],{"name":260,"role":99,"phone":261,"phoneExt":44,"email":262},"Stefano Tamberi, MD","+290544287175","stefano.tamberi@auslromagna.it",{"facility":264,"status":105,"city":265,"state":265,"zip":266,"country":125,"countryCode":126,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Policlinico Universitario Gemelli","Roma","00168",{"type":111,"coordinates":268},[269,270],11.10642,44.99364,{"lat":270,"lon":269},[273],{"name":274,"role":99,"phone":275,"phoneExt":44,"email":276},"Lisa Salvatore, MD","+390630156318","lisa.salvatore@policlinicogemelli.it",{"facility":278,"status":105,"city":279,"state":280,"zip":281,"country":125,"countryCode":126,"cosmosGeoPoint":282,"geoPoint":286,"contacts":287},"Istituto di Candiolo","Candiolo","Torino","10060",{"type":111,"coordinates":283},[284,285],7.59812,44.95858,{"lat":285,"lon":284},[288],{"name":289,"role":99,"phone":290,"phoneExt":44,"email":291},"Elisabetta Fenocchio, MD","+390119933250","elisabetta.fenocchio@ircc.it",{"facility":94,"status":105,"city":293,"state":293,"zip":294,"country":295,"countryCode":296,"cosmosGeoPoint":297,"geoPoint":301,"contacts":302},"Barcelona","08003","Spain","ES",{"type":111,"coordinates":298},[299,300],2.15899,41.38879,{"lat":300,"lon":299},[303],{"name":304,"role":99,"phone":305,"phoneExt":44,"email":306},"Clara Montagut, MD","+34932483137","cmontagut@psmar.cat",{"facility":308,"status":105,"city":293,"state":293,"zip":309,"country":295,"countryCode":296,"cosmosGeoPoint":310,"geoPoint":312,"contacts":313},"Hospital Universitari Vall d'Hebron","08035",{"type":111,"coordinates":311},[299,300],{"lat":300,"lon":299},[314],{"name":315,"role":99,"phone":316,"phoneExt":44,"email":317},"Elena Elez, MD","+349327460000","meelez@vhio.net",{"facility":319,"status":105,"city":320,"state":295,"zip":321,"country":295,"countryCode":296,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"INCLIVA Instituto de Investigación Sanitaria","Valencia","46010",{"type":111,"coordinates":323},[324,325],-0.37966,39.47391,{"lat":325,"lon":324},[328],{"name":329,"role":99,"phone":330,"phoneExt":44,"email":331},"Noela Tarazona, MD","+34961973517","noetalla@incliva.es",{"facility":333,"status":105,"city":293,"state":44,"zip":334,"country":295,"countryCode":296,"cosmosGeoPoint":335,"geoPoint":337,"contacts":338},"Hospital Sant Pau Barcelona","08041",{"type":111,"coordinates":336},[299,300],{"lat":300,"lon":299},[339],{"name":340,"role":99,"phone":341,"phoneExt":44,"email":342},"David Paez, MD","+34935565631","DPaez@santpau.cat",{"facility":344,"status":105,"city":293,"state":44,"zip":345,"country":295,"countryCode":296,"cosmosGeoPoint":346,"geoPoint":348,"contacts":349},"Consorci Corporació Sanitària Parc Taulí","08208",{"type":111,"coordinates":347},[299,300],{"lat":300,"lon":299},[350],{"name":351,"role":99,"phone":352,"phoneExt":44,"email":353},"Rosa Querol Niñerola, MD","+34937280609","rquerol@tauli.cat",{"facility":355,"status":105,"city":293,"state":44,"zip":356,"country":295,"countryCode":296,"cosmosGeoPoint":357,"geoPoint":359,"contacts":360},"Instituto Catalán de Oncologia","08908",{"type":111,"coordinates":358},[299,300],{"lat":300,"lon":299},[361],{"name":362,"role":99,"phone":363,"phoneExt":44,"email":364},"Cristina Santos, MD","+3493267733","csantos@iconcologia.net",{"facility":366,"status":105,"city":367,"state":44,"zip":368,"country":295,"countryCode":296,"cosmosGeoPoint":369,"geoPoint":373,"contacts":374},"Hospital Universitario Reina Sofia","Córdoba","14004",{"type":111,"coordinates":370},[371,372],-4.77275,37.89155,{"lat":372,"lon":371},[375],{"name":376,"role":99,"phone":377,"phoneExt":44,"email":378},"Enrique Aranda, MD","+34957736231","earandaa@seom.org",{"facility":380,"status":105,"city":381,"state":44,"zip":382,"country":295,"countryCode":296,"cosmosGeoPoint":383,"geoPoint":387,"contacts":388},"Hospital Clinico Universitario San Carlos","Madrid","28040",{"type":111,"coordinates":384},[385,386],-3.70256,40.4165,{"lat":386,"lon":385},[389],{"name":390,"role":99,"phone":391,"phoneExt":44,"email":392},"Javier Sastre, MD","+34913303000","jsastrev@salud.madrid.org",{"facility":394,"status":105,"city":395,"state":44,"zip":396,"country":295,"countryCode":296,"cosmosGeoPoint":397,"geoPoint":401,"contacts":402},"Complejo Hospitalario de Navarra","Pamplona","31008",{"type":111,"coordinates":398},[399,400],-1.64323,42.81687,{"lat":400,"lon":399},[403],{"name":404,"role":99,"phone":405,"phoneExt":44,"email":406},"Ruth Vera, MD","+34848422576","ruth.vera.garcia@navarra.es",{"facility":408,"status":105,"city":409,"state":44,"zip":410,"country":295,"countryCode":296,"cosmosGeoPoint":411,"geoPoint":415,"contacts":416},"Hospital Universitario Marqués de Valdecilla","Santander","39008",{"type":111,"coordinates":412},[413,414],-3.80493,43.46589,{"lat":414,"lon":413},[417],{"name":418,"role":99,"phone":419,"phoneExt":44,"email":420},"Carlos López, MD","+34942 202520","carlos.lopez@scsalud.es",{"facility":422,"status":105,"city":423,"state":44,"zip":424,"country":295,"countryCode":296,"cosmosGeoPoint":425,"geoPoint":429,"contacts":430},"Hospital Clínico Universitario de Santiago","Santiago de Compostela","15706",{"type":111,"coordinates":426},[427,428],-8.54569,42.88052,{"lat":428,"lon":427},[431],{"name":432,"role":99,"phone":433,"phoneExt":44,"email":434},"Juan Ruiz, MD","+34981950511","juan.ruiz.banobre@sergas.es",{"facility":436,"status":105,"city":320,"state":44,"zip":437,"country":295,"countryCode":296,"cosmosGeoPoint":438,"geoPoint":440,"contacts":441},"Hospital General Universitario de Valencia","46014",{"type":111,"coordinates":439},[324,325],{"lat":325,"lon":324},[442],{"name":443,"role":99,"phone":444,"phoneExt":44,"email":445},"Maria José Safont, MD","+3496473400","safont_mar@gva.es",{"facility":447,"status":105,"city":448,"state":44,"zip":449,"country":295,"countryCode":296,"cosmosGeoPoint":450,"geoPoint":454,"contacts":455},"Hospital Universitario Miguel Servet","Zaragoza","50009",{"type":111,"coordinates":451},[452,453],-0.87734,41.65606,{"lat":453,"lon":452},[456],{"name":457,"role":99,"phone":458,"phoneExt":44,"email":459},"Vicente Alonso, MD","+34976765500","valonsoo@salud.aragon.es",{"type":461,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100553780","phase-3-the-sagittarius-trial-100553780",false,"NCT06490536","The Sagittarius Trial","A Precision Medicine Trial Leveraging Blood-Based Tumor Genomics to Optimize Treatment in Operable Stage III and High-Risk Stage II Colon Cancer Patients","Inclusion Criteria:\n\n* SAGITTARIUS trial written informed consent.\n* Age ≥ 18 years.\n* Histologically confirmed diagnosis of operable stage III and High-Risk stage II CC located at least 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery.\n* Availability of the original FFPE tumor tissue.\n* ECOG performance status 0-1.\n* Normal organ functions (as defined in section 9.3).\n* Women with childbearing potential (WOCBP) should complete a pregnancy test and be willing to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n* History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage).\n* Current or recent treatment with another investigational drug or participation in another investigational study.\n* Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n* Inadequate contraception (male or female patients) if of childbearing or procreational potential.\n* Clinically relevant cardiovascular disease.\n* Acute or subacute intestinal occlusion or history of inflammatory bowel disease or any other autoimmune disease.\n* Pre-existing neuropathy \\> grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.\n* Has a known history of Human Immunodeficiency Virus (HIV).\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus infection.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Has a medical condition that contraindicate the use of the investigational medicinal product (IMP) according to product indications.\n* Prior neoadjuvant treatment administered before surgery.","ALL","18 Years",{"count":472,"type":473},700,"ESTIMATED","INTERVENTIONAL",[476],"PHASE3","Background \\& Rationale:\n\nColon cancer is a leading cause of cancer deaths, with a high recurrence rate in stage II high-risk and stage III patients due to undetectable micro-metastases. Liquid biopsy (LB) detects residual cancer DNA post-surgery and monitors treatment response.\n\nPrimary Objective:\n\nShow that therapy based on tumor genetics and LB improves outcomes and quality of life for high-risk stage II and stage III colon cancer patients compared to conventional therapy.\n\nSecondary Objectives:\n\nCompare recurrence times. Evaluate side effects and quality of life. Assess cost differences. Validate LB accuracy.\n\nStudy Design: Patients are randomized into standard or personalized treatment groups based on LB results.\n\nFor positive LB results:\n\nRandomized to standard or customized therapy. Monitor treatment response with LB.\n\nFor negative LB results:\n\nRandomized to standard chemotherapy or follow-ups, starting treatment if a positive result appears.\n\nTreatments:\n\nStandard Chemotherapy:\n\nCAPOX (capecitabine and oxaliplatin) FOLFOX (folinic acid, fluorouracil, and oxaliplatin)\n\nPersonalized Treatments:\n\nCustomized chemotherapy with CAPOX. Immunotherapy with nivolumab and ipilimumab. Targeted therapy with trastuzumab and pertuzumab. FOLFOX with anti-EGFR (epidermal growth factor receptor) therapy (panitumumab).\n\nPopulation: 700 patients with operable stage III and high-risk stage II colon cancer.\n\nInclusion Criteria:\n\nAged 18 or older. Confirmed diagnosis. Tumor tissue sample available.\n\nExclusion Criteria:\n\nHistory of other tumors within five years. Metastatic disease or recent experimental study participation. Major cardiovascular diseases, intestinal obstruction, autoimmune diseases, neuropathy, HIV (Human Immunodeficiency Virus), active TB (Tuberculosis), or hepatitis B\u002FC infection.\n\nMedical conditions contraindicating treatment. Prior neoadjuvant treatment administered before surgery.\n\nEndpoints:\n\nPrimary:\n\nEvaluate disease recurrence after two years.\n\nSecondary:\n\nAssess disease recurrence and overall survival at 3 and 5 years. Measure treatment safety and tolerability. Validate LB accuracy. Monitor quality of life using questionnaires.\n\nThe study will last 5 years and be conducted in 25-30 hospitals across Italy, Spain, and Germany.",[479,480],"Colon Cancer Stage II","Colon Cancer Stage III","2025-08-22",{"date":483,"type":484},"2025-08-29","ACTUAL",{"date":486,"type":484},"2024-10-22",{"date":488,"type":473},"2028-09-01",{"name":5,"class":6},26]