[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568424":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":272,"collaborators":26,"id":274,"slug":275,"hasResults":276,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":276,"sex":282,"minAge":283,"maxAge":26,"enrollmentInfo":284,"targetDuration":26,"studyType":287,"phases":288,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":298,"whyStopped":26,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},{"fullName":5,"class":6},"Institut Cancerologie de l'Ouest","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control ARM","ACTIVE_COMPARATOR","Systemic treatments",[13],"Drug: Standard Medical Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental ARM","EXPERIMENTAL","PIPAC procedure with pressurized aerosol containing oxaliplatin.",[13,19],"Procedure: PIPAC",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Standard Medical Therapy","Intravenous doublet chemotherapy FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF).\n\nAdministered every 2 weeks for 12 cycles. Dosage and administration at recommended doses.",[9,15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","PIPAC","In addition to standard systemic treatment, patients receive also four PIPAC procedures with pressurized aerosol containing oxaliplatin.\n\nThe PIPAC procedure is repeated up to a maximum of 4 times every 6 weeks.",[15],[33],{"name":34,"affiliation":35,"role":36},"Frédéric DUMONT, MD","Institut de Cancérologie de l'Ouest","PRINCIPAL_INVESTIGATOR",[38,42],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+33240679900","frederic.dumont@ico.unicancer.fr",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Emilie DEBEAUPUIS","+33240679844","emilie.debeaupuis@ico.unicancer.fr",[47,65,80,95,110,125,140,155,167,182,195,210,225,242,257],{"facility":48,"status":26,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Centre François Baclesse","Caen","14076","France","FR",{"type":54,"coordinates":55},"Point",[56,57],-0.35912,49.18585,{"lat":57,"lon":56},[60,64],{"name":61,"role":39,"phone":62,"phoneExt":26,"email":63},"Sharmini VARATHARAJAH, MD","+33231455002","s.varatharajah@baclesse.unicancer.fr",{"name":61,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":66,"status":26,"city":67,"state":26,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Centre Georges François Leclerc","Dijon","21079",{"type":54,"coordinates":70},[71,72],5.01391,47.31344,{"lat":72,"lon":71},[75,79],{"name":76,"role":39,"phone":77,"phoneExt":26,"email":78},"David ORRY, MD","+33380737508","dorry@cgfl.fr",{"name":76,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":81,"status":26,"city":82,"state":26,"zip":83,"country":51,"countryCode":52,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"CHU","Lille","59045",{"type":54,"coordinates":85},[86,87],3.05512,50.63391,{"lat":87,"lon":86},[90,94],{"name":91,"role":39,"phone":92,"phoneExt":26,"email":93},"Clarisse EVENO, MD","+33320445506","clarisse.eveno@chu-lille.fr",{"name":91,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":96,"status":26,"city":97,"state":26,"zip":98,"country":51,"countryCode":52,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"CHU Dupuytren","Limoges","87042",{"type":54,"coordinates":100},[101,102],1.24759,45.83362,{"lat":102,"lon":101},[105,109],{"name":106,"role":39,"phone":107,"phoneExt":26,"email":108},"Sylvaine DURAND, MD","+33699022340","sylvaine.durand-fontanier@chu-limoges.fr",{"name":106,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":111,"status":26,"city":112,"state":26,"zip":113,"country":51,"countryCode":52,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"APHM La Timone","Marseille","13385",{"type":54,"coordinates":115},[116,117],5.38107,43.29695,{"lat":117,"lon":116},[120,124],{"name":121,"role":39,"phone":122,"phoneExt":26,"email":123},"Nicolas PIRRO, MD","+33491388487","nicolas.pirro@ap-hm.fr",{"name":121,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":126,"status":26,"city":127,"state":26,"zip":128,"country":51,"countryCode":52,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Institut de Cancérologie de Montpellier (ICM)","Montpellier","34298",{"type":54,"coordinates":130},[131,132],3.87635,43.61093,{"lat":132,"lon":131},[135,139],{"name":136,"role":39,"phone":137,"phoneExt":26,"email":138},"Olivia SGABURA, MD","+33467613103","olivia.sgarbura@icm.unicancer.fr",{"name":136,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":141,"status":26,"city":142,"state":26,"zip":143,"country":51,"countryCode":52,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"APHP Saint Louis","Paris","75010",{"type":54,"coordinates":145},[146,147],2.3488,48.85341,{"lat":147,"lon":146},[150,154],{"name":151,"role":39,"phone":152,"phoneExt":26,"email":153},"Diane GOERE, MD","+33142499718","diane.goere@aphp.fr",{"name":151,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":156,"status":26,"city":142,"state":26,"zip":157,"country":51,"countryCode":52,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"APHP Hôpital Européen Georges Pompidou","75015",{"type":54,"coordinates":159},[146,147],{"lat":147,"lon":146},[162,166],{"name":163,"role":39,"phone":164,"phoneExt":26,"email":165},"Antoine MARIANI, MD","+33156093562","antoine.mariani@aphp.fr",{"name":163,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":168,"status":26,"city":169,"state":26,"zip":170,"country":51,"countryCode":52,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Hospices Civils de Lyon - Hôpital Lyon Sud","Pierre-Bénite","69495",{"type":54,"coordinates":172},[173,174],4.82424,45.70359,{"lat":174,"lon":173},[177,181],{"name":178,"role":39,"phone":179,"phoneExt":26,"email":180},"Vahan KEPENEKIAN, MD","+33478862371","vahan.kepenekian@chu-lyon.fr",{"name":178,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":183,"status":26,"city":184,"state":26,"zip":185,"country":51,"countryCode":52,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Institut de Cancérologie de l'Ouest - Saint Herblain","Saint-Herblain","44805",{"type":54,"coordinates":187},[188,189],-1.651,47.21154,{"lat":189,"lon":188},[192,194],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":193},"frédéric.dumont@ico.unicancer.fr",{"name":34,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":196,"status":26,"city":197,"state":26,"zip":198,"country":51,"countryCode":52,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Hôpital d'Instruction des Armées Bégin","Saint-Mandé","94160",{"type":54,"coordinates":200},[201,202],2.41579,48.83864,{"lat":202,"lon":201},[205,209],{"name":206,"role":39,"phone":207,"phoneExt":26,"email":208},"Anne-Cécile EZANNO, MD","+33143985250","ezanno.annececile@gmail.com",{"name":206,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":211,"status":26,"city":212,"state":26,"zip":213,"country":51,"countryCode":52,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"CHRU","Strasbourg","67098",{"type":54,"coordinates":215},[216,217],7.74553,48.58392,{"lat":217,"lon":216},[220,224],{"name":221,"role":39,"phone":222,"phoneExt":26,"email":223},"Cécile BRIGAND, MD","+33388126085","cecile.brigand@chru-strasbourg.fr",{"name":221,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":226,"status":26,"city":227,"state":26,"zip":228,"country":51,"countryCode":52,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Centre Hospitalier TARBES","Tarbes","65013",{"type":54,"coordinates":230},[231,232],0.07139,43.23407,{"lat":232,"lon":231},[235,238,240],{"name":236,"role":39,"phone":26,"phoneExt":26,"email":237},"Amandine PINTO, Doctor","apinto@ch-tarbes-vic.fr",{"name":26,"role":39,"phone":239,"phoneExt":26,"email":26},"+33562546231",{"name":241,"role":39,"phone":26,"phoneExt":26,"email":26},"Amandine PINTO, MD",{"facility":243,"status":26,"city":244,"state":26,"zip":245,"country":51,"countryCode":52,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"Institut de Cancérologie de Lorraine (ICL)","Vandœuvre-lès-Nancy","54500",{"type":54,"coordinates":247},[248,249],6.17114,48.66115,{"lat":249,"lon":248},[252,256],{"name":253,"role":39,"phone":254,"phoneExt":26,"email":255},"Cécilia CERIBELLI, MD","+33383598451","c.cerribelli@nancy.unicancer.fr",{"name":253,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":258,"status":26,"city":259,"state":26,"zip":260,"country":51,"countryCode":52,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Gustave Roussy","Villejuif","94805",{"type":54,"coordinates":262},[263,264],2.35992,48.7939,{"lat":264,"lon":263},[267,271],{"name":268,"role":39,"phone":269,"phoneExt":26,"email":270},"Isabelle SOURROUILLE, MD","+33142114350","isabelle.sourrouille@gustaveroussy.fr",{"name":268,"role":39,"phone":26,"phoneExt":26,"email":26},{"type":273,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100568424","phase-2-systemic-antitumor-treatment-with-or-without-pressurized-intraperitoneal-aerosol-chemotherapy-for-colon-peritoneal-metastases-pipox02-100568424",false,"NCT06681038","Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy for Colon Peritoneal Metastases (PIPOX02)","Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Colon Peritoneal Metastases - a Multicentre Phase II Randomized Trial (PIPOX02)","PIPOX02","Inclusion Criteria:\n\n* ECOG performance status of 0 to 2;\n* Histopathologically confirmed colonic adenocarcinoma with synchronous or metachronous peritoneal metastasis (PM);\n* Unresectable PM defined as any of the following:\n\n  * PCI \\>15\n  * Extended small bowell involvement\n  * Poor general condition contra-indication to a major abdominal surgery (eg: a complete cytoreductive surgery), as decided by the medico-surgical team of the investigator's site specialised in peritoneal carcinomatosis in charge of the patient.\n* A surgical exploration performed less than 4 weeks before inclusion (if not, a laparoscopic exploration must be performed);\n* First line systemic chemotherapy for advanced \u002F metastatic colonic adenocarcinoma. Systemic chemotherapy in an adjuvant setting is allowed if completed more than 6 months before recurrence and without persistent oxaliplatin-induced neuropathy;\n* No extended intraperitoneal adherences defined by at least 9 out of 13 abdominal regions correctly explored during surgical exploration (laparoscopy or laparotomy;\n\nExclusion Criteria:\n\n* Other cancer treated within the last 3 years, with the exception of in situ cervical carcinoma or basocellular carcinoma;\n* Rectal cancer primary (tumor \\\u003C15 cm from the anal verge);\n* Mutational status corresponding to microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR);\n* Complete or partial bowel obstruction unresponsive to medical treatment;\n* Extraperitoneal polymetastatic diseases. (Only oligometastatic1 diseases are allowed for inclusion);\n* History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 6 months prior to enrolment;\n* Active gastrointestinal bleeding;\n* Inflammatory bowel disease;\n* Peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0, grade ≥2","ALL","18 Years",{"count":285,"type":286},114,"ESTIMATED","INTERVENTIONAL",[289],"PHASE2","The goal of this clinical trial is to learn if Pressurized intraperitoneal aerosol chemotherapy (PIPAC) significantly improve the progression-free survival (PFS) in patients with advanced peritoneal metastasis from colorectal cancer.\n\nResearchers will compare 2 strategies, systemic treatments (chemotherapy + targeted therapy) corresponding to standard treatment with or without intraperitoneal oxaliplatin (PIPAC) to see if PIPAC improve the progression-free survival.\n\nParticipants will:\n\n* receive a standard treatment every 2 weeks for 12 cycles of intravenous FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF) in the both arms.\n* receive up to a maximum of 4 PIPAC every 6 weeks with pressurized aerosol containing oxaliplatin in experimental arm.\n* receive a maintenance treatment until progression or until the onset of severe toxicity after 12 cycles.\n* be asked to perform a CT scan and carcinoembryonic antigen (CEA) assay every 8 weeks until progression",[292],"Peritoneal Metastases from Colorectal Cancer",[294,295,296,297],"Surgical oncology","Peritoneal metastasis","Pressurized IntraPeritoneal Aerosol Chemotherapy","Systemic chemotherapy","NOT_YET_RECRUITING","2024-11-07",{"date":301,"type":302},"2024-11-08","ACTUAL",{"date":304,"type":286},"2025-02",{"date":306,"type":286},"2029-08",{"name":5,"class":6},15]