[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622295":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":47,"responsibleParty":345,"collaborators":28,"id":349,"slug":350,"hasResults":351,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":351,"sex":357,"minAge":358,"maxAge":28,"enrollmentInfo":359,"targetDuration":28,"studyType":362,"phases":363,"briefSummary":365,"conditions":366,"keywords":28,"overallStatus":368,"whyStopped":28,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":378},{"fullName":5,"class":6},"Gruppo Oncologico Italia Meridionale","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Arm A - Irinotecan + Cetuximab","EXPERIMENTAL","This arm is for participants with molecularly selected metastatic colorectal cancer who have progressed after standard first- and second-line therapies and previously achieved clinical benefit from an anti-EGFR-based regimen. Participants randomized to this arm will receive irinotecan in combination with cetuximab as a rechallenge strategy. The objective of this arm is to evaluate the antitumor activity and safety of irinotecan plus cetuximab compared with the control treatment in the third-line setting.",[13,14],"Drug: Erbitux (Cetuximab)","Drug: Irinotecan",{"label":16,"type":17,"description":18,"interventionNames":19},"Active Comparator: Arm B - Trifluridine\u002FTipiracil + Bevacizumab","ACTIVE_COMPARATOR","This arm is for participants with molecularly selected metastatic colorectal cancer who have progressed after standard first- and second-line therapies. Participants randomized to this arm will receive trifluridine\u002Ftipiracil in combination with bevacizumab, which represents the current standard of care in the third-line treatment setting. This arm serves as the control group for comparison with the experimental rechallenge strategy.",[20,21],"Drug: Bevacizumab","Drug: Trifluridine\u002Ftipiracil",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Erbitux (Cetuximab)","This is an anti-EGFR monoclonal antibody administered in combination with chemotherapy. The dose is 500 mg\u002Fm2 over 120 minutes",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Bevacizumab","This is an anti-VEGF monoclonal antibody used as an active comparator in the control arm of the study. The dose is 5 mg\u002FKg of body weight given once every 2 weeks.",[16],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Irinotecan","Irinotecan is a cytotoxic chemotherapy agent administered intravenously in combination with cetuximab the dose is 180 mg\u002Fm2 over 90 minutes, once every 2 weeks.",[9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Trifluridine\u002Ftipiracil","Trifluridine\u002Ftipiracil is an oral antineoplastic combination administered in combination with bevacizumab as part of the control treatment arm. The dose is 5 mg\u002F m² twice daily on Days 1 to 5 and Days 8 to 12 on a cycle of 28 days.",[16],[42],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Davide Ciardiello DC Principal Investigator","CONTACT","02\u002F94372686","davide.ciardiello@ieo.it",[48,64,77,90,103,116,129,142,155,168,181,191,199,207,220,228,233,241,254,264,277,290,303,311,319,332],{"facility":49,"status":28,"city":50,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Azienda Ospedaliero Universitaria \"SS Antonio e Biagio e Cesare Arrigo\"","Alessandria","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],8.61007,44.90924,{"lat":57,"lon":56},[60],{"name":61,"role":44,"phone":62,"phoneExt":28,"email":63},"Giulia Piacentini Principal Investigator","0131 206893","giulia.piacentini@ospedale.al.it",{"facility":65,"status":28,"city":66,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"A.O.U. Ospedali Riuniti","Ancona",{"type":54,"coordinates":68},[69,70],13.5103,43.60717,{"lat":70,"lon":69},[73],{"name":74,"role":44,"phone":75,"phoneExt":28,"email":76},"Rossana Berardi Principal Investigator","071\u002F5965715","rossana.berardi@ospedaliriuniti.marche.it",{"facility":78,"status":28,"city":79,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Centro di Riferimento Oncologico (CRO), IRCCS","Aviano",{"type":54,"coordinates":81},[82,83],12.59472,46.07056,{"lat":83,"lon":82},[86],{"name":87,"role":44,"phone":88,"phoneExt":28,"email":89},"Luisa Foltran Principal Investigator","0434 399652","luisa.foltran@cro.it",{"facility":91,"status":28,"city":92,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"A.O.R.N. \"Sant'anna e San Sebastiano\"","Caserta",{"type":54,"coordinates":94},[95,96],14.33231,41.07262,{"lat":96,"lon":95},[99],{"name":100,"role":44,"phone":101,"phoneExt":28,"email":102},"Michele Orditura Principal Investigator","0823232515","michele.orditura@aorncaserta.it",{"facility":104,"status":28,"city":105,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Ospedale IRCCS 'Saverio de Bellis'","Castellana Grotte",{"type":54,"coordinates":107},[108,109],17.16549,40.88643,{"lat":109,"lon":108},[112],{"name":113,"role":44,"phone":114,"phoneExt":28,"email":115},"Claudio Lotesoriere Principal Investigator","080\u002F4994688","claudio.lotesoriere@irccsdebellis.it",{"facility":117,"status":28,"city":118,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"A.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima","Catania",{"type":54,"coordinates":120},[121,122],15.07041,37.49223,{"lat":122,"lon":121},[125],{"name":126,"role":44,"phone":127,"phoneExt":28,"email":128},"Roberto Bordonaro Principal Investigator","095\u002F7595936","rbordonaro63@gmail.com",{"facility":130,"status":28,"city":131,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Azienda Ospedaliero-Universitaria Renato Dulbecco","Catanzaro",{"type":54,"coordinates":133},[134,135],16.60086,38.88247,{"lat":135,"lon":134},[138],{"name":139,"role":44,"phone":140,"phoneExt":28,"email":141},"Pierosandro Tagliaferri Principal Investigator","0961\u002F3694324","tagliaferri@unicz.it",{"facility":143,"status":28,"city":144,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"A.O.U. Careggi","Florence",{"type":54,"coordinates":146},[147,148],11.24626,43.77925,{"lat":148,"lon":147},[151],{"name":152,"role":44,"phone":153,"phoneExt":28,"email":154},"Lorenzo Antonuzzo Principal Investigator","0557947298","lorenzo.antonuzzo@unifi.it",{"facility":156,"status":28,"city":157,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori'","Meldola",{"type":54,"coordinates":159},[160,161],12.0626,44.12775,{"lat":161,"lon":160},[164],{"name":165,"role":44,"phone":28,"phoneExt":166,"email":167},"Alessandro Passardi Principal Investigator","0543739100","alessandro.passardi@irst.emr.it",{"facility":169,"status":28,"city":170,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"ASST Grande Ospedale Metropolitano Niguarda","Milan",{"type":54,"coordinates":172},[173,174],12.59836,42.78235,{"lat":174,"lon":173},[177],{"name":178,"role":44,"phone":179,"phoneExt":28,"email":180},"Andrea Sartore-Bianchi Principal Investigator","02\u002F64443708","andrea.sartorebianchi@unimi.it",{"facility":182,"status":28,"city":170,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":183,"geoPoint":185,"contacts":186},"Fondazione IRCCS Istituto Nazionale Tumori",{"type":54,"coordinates":184},[173,174],{"lat":174,"lon":173},[187],{"name":188,"role":44,"phone":189,"phoneExt":28,"email":190},"Filippo Pietrantonio Principal Investigator","02\u002F23903807","filippo.pietrantonio@istitutotumori.mi.it",{"facility":192,"status":28,"city":170,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":193,"geoPoint":195,"contacts":196},"Istituto Europeo di Oncologia",{"type":54,"coordinates":194},[173,174],{"lat":174,"lon":173},[197],{"name":198,"role":44,"phone":45,"phoneExt":28,"email":46},"Davide Ciardiello Principal Investigator",{"facility":200,"status":28,"city":201,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":202,"geoPoint":206,"contacts":28},"Casa di Cura Villa Maria","Mirabella Eclano",{"type":54,"coordinates":203},[204,205],15.00022,41.04496,{"lat":205,"lon":204},{"facility":208,"status":28,"city":209,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"AOU Policlinico di Modena","Modena",{"type":54,"coordinates":211},[212,213],10.92539,44.64783,{"lat":213,"lon":212},[216],{"name":217,"role":44,"phone":218,"phoneExt":28,"email":219},"Fabio Gelsomino Principal Investigator","059 4222230","gelsomino.fabio@aou.mo.it",{"facility":221,"status":28,"city":222,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":223,"geoPoint":227,"contacts":28},"A.O.U. dell'Università degli studi della Campania \"Luigi Vanvitelli\"","Naples",{"type":54,"coordinates":224},[225,226],14.26811,40.85216,{"lat":226,"lon":225},{"facility":229,"status":28,"city":222,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":230,"geoPoint":232,"contacts":28},"Istituto Nazionale Tumori 'Fondazione G. Pascale'",{"type":54,"coordinates":231},[225,226],{"lat":226,"lon":225},{"facility":234,"status":28,"city":235,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":236,"geoPoint":240,"contacts":28},"Istituto Oncologico Veneto IRCCS","Padova",{"type":54,"coordinates":237},[238,239],11.14261,44.38225,{"lat":239,"lon":238},{"facility":242,"status":28,"city":243,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"ARNAS Civico - Di Cristina-Benfratelli - P. O. 'Civico e Benfratelli'","Palermo",{"type":54,"coordinates":245},[246,247],13.3636,38.1166,{"lat":247,"lon":246},[250],{"name":251,"role":44,"phone":252,"phoneExt":28,"email":253},"Marco Messina Principal Investigator","340.4034246","marco.messina@arnascivico.it",{"facility":255,"status":28,"city":243,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":256,"geoPoint":258,"contacts":259},"Casa di cura Macchiarella",{"type":54,"coordinates":257},[246,247],{"lat":247,"lon":246},[260],{"name":261,"role":44,"phone":262,"phoneExt":28,"email":263},"Alfredo Colombo Principal Investigator","3355273795","Alfredocolombo63@gmail.com",{"facility":265,"status":28,"city":266,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"A.O.U. Pisana","Pisa",{"type":54,"coordinates":268},[269,270],10.4036,43.70853,{"lat":270,"lon":269},[273],{"name":274,"role":44,"phone":275,"phoneExt":28,"email":276},"Chiara Cremolini Principal Investigator","050\u002F992192","chiaracremolini@gmail.com",{"facility":278,"status":28,"city":279,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS","Roma",{"type":54,"coordinates":281},[282,283],11.10642,44.99364,{"lat":283,"lon":282},[286],{"name":287,"role":44,"phone":288,"phoneExt":28,"email":289},"Giampaolo Tortora Principal Investigator","06\u002F30155202","giampaolo.tortora@policlinicogemelli.it",{"facility":291,"status":28,"city":292,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza","San Giovanni Rotondo",{"type":54,"coordinates":294},[295,296],15.7277,41.70643,{"lat":296,"lon":295},[299],{"name":300,"role":44,"phone":301,"phoneExt":28,"email":302},"Tiziana Pia Latiano Principal Investigator","0882\u002F410716","latiano.tiziana@gmail.com",{"facility":304,"status":28,"city":305,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":306,"geoPoint":310,"contacts":28},"A.O.U. Sassari","Sassari",{"type":54,"coordinates":307},[308,309],8.55552,40.72586,{"lat":309,"lon":308},{"facility":312,"status":28,"city":313,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":314,"geoPoint":318,"contacts":28},"Ospedale San Giuseppe Moscati","Statte",{"type":54,"coordinates":315},[316,317],17.20122,40.52856,{"lat":317,"lon":316},{"facility":320,"status":28,"city":321,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"A.O. 'Pia Fondazione Cardinale G. Panico'","Tricase",{"type":54,"coordinates":323},[324,325],18.35421,39.93018,{"lat":325,"lon":324},[328],{"name":329,"role":44,"phone":330,"phoneExt":28,"email":331},"Maria Laura Iaia Principal Investigator","0833.773111","iaia.mlaura4@gmail.com",{"facility":333,"status":28,"city":334,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"ASST Sette Laghi-Ospedale di Circolo Fondazione Macchi","Varese",{"type":54,"coordinates":336},[337,338],8.82511,45.82058,{"lat":338,"lon":337},[341],{"name":342,"role":44,"phone":343,"phoneExt":28,"email":344},"Michele Ghidini Principal Investigator","0332278558","michele.ghidini@asst-settelaghi.it",{"type":346,"investigatorFullName":347,"investigatorTitle":348,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Davide Ciardiello","Principal Investigator","100622295","phase-2-romance-irinotecan-plus-cetuximab-rechallenge-versus-trifluridinetipiracil-plus-bevacizumab-in-molecularly-selected-metastatic-colorectal-cancer-100622295",false,"NCT07381764","ROMANCE: \"Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine\u002FTipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer\"","ROMANCE GOIM Study: A Phase II, Open Label, Multicenter Trial Investigating Irinotecan Plus Cetuximab Rechallenge Compared With Trifluridine\u002FTipiracil Plus Bevacizumab as Third Line Treatment in Circulating Tumor DNA Molecularly Selected Metastatic Colorectal Cancer","ROMANCE - GOIM","Inclusion Criteria:\n\n1. Male or female aged ≥18 years\n2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1\n3. Diagnosis of histologically or cytologically confirmed colorectal cancer.\n4. At least one measurable lesion according to RECIST1.1\n5. KRAS\u002FNRAS\u002FBRAFV600E wt status of primary CRC or related metastasis (local laboratory assessment).\n6. Progression to previous first-line anti-EGFR-containing therapy producing at least a partial response ≥ 6 months.\n7. Received and progressed to an anti-EGFR and irinotecan free second-line treatment.\n8. Have an anti-EGFR free interval of at least 4 months.\n9. Refractory to previous 5-fluorouracil\u002Fcapecitabine, irinotecan, oxaliplatin, bevacizumab.\n10. RAS\u002FBRAF\u002FEGFR\u002FPIK3CAex20\u002FMAP2K1\u002FMET WT and HER2 not amplified ctDNA at FoundationOne CDx test at baseline.\n11. Life expectancy of at least 3 months.\n12. Adequate hematological function defined by white blood cell (WBC) count ≥ 2.5 × 109\u002FL with absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, lymphocyte count ≥ 0.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, and hemoglobin ≥ 9 g\u002FdL (may have been transfused).\n13. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all subjects or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).\n14. Adequate renal function defined by an estimated creatinine clearance \\> 30 mL\u002Fmin according to the Cockcroft-Gault formula (or local institutional standard method).\n15. No contraindication to the study drugs.\n16. No prior treatment with trifluridine\u002Ftipiracil.\n17. Women of childbearing potential\\* must have a negative blood pregnancy test at thescreening visit. Subjects and their partners must be willing to avoid pregnancy during the trial.\n\n    \\*A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n18. Women of childbearing potential, or male, must agree to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 6 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate.\n19. Will and ability to comply with the protocol.\n20. Signed informed consent obtained before screening.\n\nExclusion Criteria:\n\n1. ECOG PS ≥2\n2. Received more than 2 lines of treatment for metastatic disease.\n3. Previous treatment with trifluridine\u002Ftipiracil\n4. RAS\u002FBRAF\u002FEGFR\u002FPIK3CAex20\u002FMAP2K1\u002FMET WT HER2 not amplified status at liquid biopsy analysis during screening.\n5. Previous history of malignancy within the last 2 years will be excluded with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ\n6. Evidence of bleeding diathesis or coagulopathy.\n7. Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.\n8. Known severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5 Grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).\n9. Clinically significant cardiovascular disease, active inflammatory bowel disease, active autoimmune disease.\n10. Diagnosis of interstitial pneumonitis or pulmonary fibrosis.\n11. History of abdominal fistula, GI perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to the first study treatment.\n12. Pregnant or lactating women.\n13. Psychiatric or addictive disorders would preclude study participation.\n14. Active uncontrolled infections or other clinically relevant concomitant illness contraindicating study treatments.\n15. Withdrawal of the consent to take part to the study.","ALL","18 Years",{"count":360,"type":361},150,"ESTIMATED","INTERVENTIONAL",[364],"PHASE2","This study is a phase II, open-label, multicenter clinical trial designed to evaluate two different treatment options for patients with metastatic colorectal cancer whose disease has progressed after standard therapies. The study compares a rechallenge treatment using irinotecan plus cetuximab with the current standard of care, trifluridine\u002Ftipiracil plus bevacizumab, as third-line therapy. Patients enrolled in the study are selected based on specific molecular characteristics of their cancer, identified through circulating tumor DNA analysis from a blood sample. The main purpose of the study is to determine whether the rechallenge with irinotecan and cetuximab leads to a higher tumor response rate compared with trifluridine\u002Ftipiracil plus bevacizumab. Secondary objectives include evaluating progression-free survival, overall survival, safety, and quality of life. Patients will be randomly assigned to one of the two treatment groups and will receive treatment until disease progression, unacceptable side effects, or withdrawal of consent. Tumor response will be assessed using standard imaging techniques according to RECIST criteria.",[367],"Metastatic Colorectal Cancer (CRC)","NOT_YET_RECRUITING","2026-01-26",{"date":371,"type":372},"2026-02-02","ACTUAL",{"date":374,"type":361},"2026-03-30",{"date":376,"type":361},"2031-03-30",{"name":5,"class":6},26]