[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568424":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":271,"collaborators":26,"id":273,"slug":26,"hasResults":274,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":274,"sex":280,"minAge":281,"maxAge":26,"enrollmentInfo":282,"targetDuration":26,"studyType":285,"phases":286,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":296,"whyStopped":26,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},{"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",[47,64,79,94,109,124,139,154,166,181,194,209,224,241,256],{"facility":48,"status":26,"city":49,"state":26,"zip":50,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Centre François Baclesse","Caen","14076","France",{"type":53,"coordinates":54},"Point",[55,56],-0.35912,49.18585,{"lat":56,"lon":55},[59,63],{"name":60,"role":39,"phone":61,"phoneExt":26,"email":62},"Sharmini VARATHARAJAH, MD","+33231455002","s.varatharajah@baclesse.unicancer.fr",{"name":60,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":65,"status":26,"city":66,"state":26,"zip":67,"country":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Centre Georges François Leclerc","Dijon","21079",{"type":53,"coordinates":69},[70,71],5.01391,47.31344,{"lat":71,"lon":70},[74,78],{"name":75,"role":39,"phone":76,"phoneExt":26,"email":77},"David ORRY, MD","+33380737508","dorry@cgfl.fr",{"name":75,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":80,"status":26,"city":81,"state":26,"zip":82,"country":51,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"CHU","Lille","59045",{"type":53,"coordinates":84},[85,86],3.05512,50.63391,{"lat":86,"lon":85},[89,93],{"name":90,"role":39,"phone":91,"phoneExt":26,"email":92},"Clarisse EVENO, MD","+33320445506","clarisse.eveno@chu-lille.fr",{"name":90,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":95,"status":26,"city":96,"state":26,"zip":97,"country":51,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"CHU Dupuytren","Limoges","87042",{"type":53,"coordinates":99},[100,101],1.24759,45.83362,{"lat":101,"lon":100},[104,108],{"name":105,"role":39,"phone":106,"phoneExt":26,"email":107},"Sylvaine DURAND, MD","+33699022340","sylvaine.durand-fontanier@chu-limoges.fr",{"name":105,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":110,"status":26,"city":111,"state":26,"zip":112,"country":51,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"APHM La Timone","Marseille","13385",{"type":53,"coordinates":114},[115,116],5.38107,43.29695,{"lat":116,"lon":115},[119,123],{"name":120,"role":39,"phone":121,"phoneExt":26,"email":122},"Nicolas PIRRO, MD","+33491388487","nicolas.pirro@ap-hm.fr",{"name":120,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":125,"status":26,"city":126,"state":26,"zip":127,"country":51,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Institut de Cancérologie de Montpellier (ICM)","Montpellier","34298",{"type":53,"coordinates":129},[130,131],3.87635,43.61093,{"lat":131,"lon":130},[134,138],{"name":135,"role":39,"phone":136,"phoneExt":26,"email":137},"Olivia SGABURA, MD","+33467613103","olivia.sgarbura@icm.unicancer.fr",{"name":135,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":140,"status":26,"city":141,"state":26,"zip":142,"country":51,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"APHP Saint Louis","Paris","75010",{"type":53,"coordinates":144},[145,146],2.3488,48.85341,{"lat":146,"lon":145},[149,153],{"name":150,"role":39,"phone":151,"phoneExt":26,"email":152},"Diane GOERE, MD","+33142499718","diane.goere@aphp.fr",{"name":150,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":155,"status":26,"city":141,"state":26,"zip":156,"country":51,"cosmosGeoPoint":157,"geoPoint":159,"contacts":160},"APHP Hôpital Européen Georges Pompidou","75015",{"type":53,"coordinates":158},[145,146],{"lat":146,"lon":145},[161,165],{"name":162,"role":39,"phone":163,"phoneExt":26,"email":164},"Antoine MARIANI, MD","+33156093562","antoine.mariani@aphp.fr",{"name":162,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":167,"status":26,"city":168,"state":26,"zip":169,"country":51,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Hospices Civils de Lyon - Hôpital Lyon Sud","Pierre-Bénite","69495",{"type":53,"coordinates":171},[172,173],4.82424,45.70359,{"lat":173,"lon":172},[176,180],{"name":177,"role":39,"phone":178,"phoneExt":26,"email":179},"Vahan KEPENEKIAN, MD","+33478862371","vahan.kepenekian@chu-lyon.fr",{"name":177,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":182,"status":26,"city":183,"state":26,"zip":184,"country":51,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Institut de Cancérologie de l'Ouest - Saint Herblain","Saint-Herblain","44805",{"type":53,"coordinates":186},[187,188],-1.651,47.21154,{"lat":188,"lon":187},[191,193],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":192},"frédéric.dumont@ico.unicancer.fr",{"name":34,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":195,"status":26,"city":196,"state":26,"zip":197,"country":51,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Hôpital d'Instruction des Armées Bégin","Saint-Mandé","94160",{"type":53,"coordinates":199},[200,201],2.41579,48.83864,{"lat":201,"lon":200},[204,208],{"name":205,"role":39,"phone":206,"phoneExt":26,"email":207},"Anne-Cécile EZANNO, MD","+33143985250","ezanno.annececile@gmail.com",{"name":205,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":210,"status":26,"city":211,"state":26,"zip":212,"country":51,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"CHRU","Strasbourg","67098",{"type":53,"coordinates":214},[215,216],7.74553,48.58392,{"lat":216,"lon":215},[219,223],{"name":220,"role":39,"phone":221,"phoneExt":26,"email":222},"Cécile BRIGAND, MD","+33388126085","cecile.brigand@chru-strasbourg.fr",{"name":220,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":225,"status":26,"city":226,"state":26,"zip":227,"country":51,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Centre Hospitalier TARBES","Tarbes","65013",{"type":53,"coordinates":229},[230,231],0.07139,43.23407,{"lat":231,"lon":230},[234,237,239],{"name":235,"role":39,"phone":26,"phoneExt":26,"email":236},"Amandine PINTO, Doctor","apinto@ch-tarbes-vic.fr",{"name":26,"role":39,"phone":238,"phoneExt":26,"email":26},"+33562546231",{"name":240,"role":39,"phone":26,"phoneExt":26,"email":26},"Amandine PINTO, MD",{"facility":242,"status":26,"city":243,"state":26,"zip":244,"country":51,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Institut de Cancérologie de Lorraine (ICL)","Vandœuvre-lès-Nancy","54500",{"type":53,"coordinates":246},[247,248],6.17114,48.66115,{"lat":248,"lon":247},[251,255],{"name":252,"role":39,"phone":253,"phoneExt":26,"email":254},"Cécilia CERIBELLI, MD","+33383598451","c.cerribelli@nancy.unicancer.fr",{"name":252,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":257,"status":26,"city":258,"state":26,"zip":259,"country":51,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"Gustave Roussy","Villejuif","94805",{"type":53,"coordinates":261},[262,263],2.35992,48.7939,{"lat":263,"lon":262},[266,270],{"name":267,"role":39,"phone":268,"phoneExt":26,"email":269},"Isabelle SOURROUILLE, MD","+33142114350","isabelle.sourrouille@gustaveroussy.fr",{"name":267,"role":39,"phone":26,"phoneExt":26,"email":26},{"type":272,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":283,"type":284},114,"ESTIMATED","INTERVENTIONAL",[287],"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",[290],"Peritoneal Metastases from Colorectal Cancer",[292,293,294,295],"Surgical oncology","Peritoneal metastasis","Pressurized IntraPeritoneal Aerosol Chemotherapy","Systemic chemotherapy","NOT_YET_RECRUITING","2024-11-07",{"date":299,"type":300},"2024-11-08","ACTUAL",{"date":302,"type":284},"2025-02",{"date":304,"type":284},"2029-08",{"name":5,"class":6},15]