[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440025":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":282,"collaborators":18,"id":284,"slug":285,"hasResults":286,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":18,"eligibilityCriteria":290,"healthyVolunteers":286,"sex":291,"minAge":292,"maxAge":18,"enrollmentInfo":293,"targetDuration":18,"studyType":296,"phases":297,"briefSummary":299,"conditions":300,"keywords":304,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":321},{"fullName":5,"class":6},"Centre Leon Berard","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Imatinib interruption","EXPERIMENTAL","Immediate interruption of imatinib until progressive disease. In case of 1st relapse, imatinib will be reintroduced at 400mg\u002Fd and further increased at 800mg\u002Fd in case of 2nd relapse after re-introduction.",[13],"Drug: Imatinib tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Imatinib maintenancce","NO_INTERVENTION","Maintenance of imatinib at the last dose routinely taken by the patient in the 10-year period prior to randomization (either 300 or 400 mg once daily). In case of progressive disease imatinib will be increased up to 800mg\u002Fday.",null,[20],{"type":21,"name":22,"description":9,"armGroupLabels":23,"otherNames":24},"DRUG","Imatinib tablets",[9],[25],"Glivec",[27],{"name":28,"affiliation":29,"role":30},"Jean-Yves BLAY, Pr","Centre Léon Bérard, Lyon","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","+33 4 78 78 27 57","jean-yves.blay@lyon.unicancer.fr",[37,61,81,94,115,142,156,173,197,214,230,248,261],{"facility":38,"status":39,"city":40,"state":18,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"CHU Besançon","RECRUITING","Besançon","25000","France","FR",{"type":45,"coordinates":46},"Point",[47,48],6.01815,47.24878,{"lat":48,"lon":47},[51,55,56,59],{"name":52,"role":33,"phone":53,"phoneExt":18,"email":54},"Elsa KALBACHER, MD","03.70.63.24.03","ekalbacher@chu-besancon.fr",{"name":52,"role":30,"phone":18,"phoneExt":18,"email":18},{"name":57,"role":58,"phone":18,"phoneExt":18,"email":18},"Loïc CHAIGNEAU, MD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":18,"phoneExt":18,"email":18},"Guillaume MEYNARD, MD",{"facility":62,"status":39,"city":63,"state":18,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Institut Bergonié","Bordeaux","33076",{"type":45,"coordinates":66},[67,68],-0.58046,44.84124,{"lat":68,"lon":67},[71,74,75,77,79],{"name":72,"role":33,"phone":18,"phoneExt":18,"email":73},"Antoine ITALIANO","A.Italiano@bordeaux.unicancer.fr",{"name":72,"role":30,"phone":18,"phoneExt":18,"email":18},{"name":76,"role":58,"phone":18,"phoneExt":18,"email":18},"Maud TOULMONDE",{"name":78,"role":58,"phone":18,"phoneExt":18,"email":18},"Kevin BOURCIER",{"name":80,"role":58,"phone":18,"phoneExt":18,"email":18},"Sophie COUSIN",{"facility":82,"status":39,"city":83,"state":18,"zip":84,"country":42,"countryCode":43,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"CHU Dupuytren","Limoges","87042",{"type":45,"coordinates":86},[87,88],1.24759,45.83362,{"lat":88,"lon":87},[91],{"name":92,"role":33,"phone":18,"phoneExt":18,"email":93},"Valérie LE BRUN LY, MD","valerie.lebrunly@chu-limoges.fr",{"facility":95,"status":39,"city":96,"state":18,"zip":97,"country":42,"countryCode":43,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Centre Léon Bérard","Lyon","69373",{"type":45,"coordinates":99},[100,101],4.84789,45.74906,{"lat":101,"lon":100},[104,106,108,109,111,113],{"name":105,"role":33,"phone":18,"phoneExt":18,"email":18},"Jean-Yves BLAY, PhD",{"name":18,"role":33,"phone":107,"phoneExt":18,"email":35},"04 78 78 27 57",{"name":105,"role":30,"phone":18,"phoneExt":18,"email":18},{"name":110,"role":58,"phone":18,"phoneExt":18,"email":18},"Mehdi BRAHMI",{"name":112,"role":58,"phone":18,"phoneExt":18,"email":18},"Armelle DUFRESNE",{"name":114,"role":58,"phone":18,"phoneExt":18,"email":18},"Isabelle RAY-COQUARD",{"facility":116,"status":117,"city":118,"state":18,"zip":119,"country":42,"countryCode":43,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Institut Paoli Calmettes","NOT_YET_RECRUITING","Marseille","13273",{"type":45,"coordinates":121},[122,123],5.38107,43.29695,{"lat":123,"lon":122},[126,129,130,132,134,136,138,140],{"name":127,"role":33,"phone":18,"phoneExt":18,"email":128},"François BERTUCCI, PhD","bertuccif@ipc.unicancer.fr",{"name":127,"role":30,"phone":18,"phoneExt":18,"email":18},{"name":131,"role":58,"phone":18,"phoneExt":18,"email":18},"Audrey MONNEUR",{"name":133,"role":58,"phone":18,"phoneExt":18,"email":18},"Elika LOIR",{"name":135,"role":58,"phone":18,"phoneExt":18,"email":18},"Simon LAUNAY",{"name":137,"role":58,"phone":18,"phoneExt":18,"email":18},"Frédéric VIRET",{"name":139,"role":58,"phone":18,"phoneExt":18,"email":18},"Brice CHANEZ",{"name":141,"role":58,"phone":18,"phoneExt":18,"email":18},"Delphine LOUVEL PERROT",{"facility":143,"status":117,"city":144,"state":18,"zip":145,"country":42,"countryCode":43,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Institut Curie","Paris","75005",{"type":45,"coordinates":147},[148,149],2.3488,48.85341,{"lat":149,"lon":148},[152,155],{"name":153,"role":33,"phone":18,"phoneExt":18,"email":154},"Sophie PIPERNO NEUMANN","sophie.piperno-neumann@curie.fr",{"name":153,"role":30,"phone":18,"phoneExt":18,"email":18},{"facility":157,"status":39,"city":158,"state":18,"zip":159,"country":42,"countryCode":43,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"CHU de Reims","Reims","51100",{"type":45,"coordinates":161},[162,163],4.02853,49.26526,{"lat":163,"lon":162},[166,168,169,171],{"name":167,"role":33,"phone":18,"phoneExt":18,"email":18},"Olivier BOUCHE, PhD",{"name":167,"role":30,"phone":18,"phoneExt":18,"email":18},{"name":170,"role":58,"phone":18,"phoneExt":18,"email":18},"Mathilde BRASSEUR, MD",{"name":172,"role":58,"phone":18,"phoneExt":18,"email":18},"Damien BOTSEN, MD",{"facility":174,"status":117,"city":175,"state":18,"zip":176,"country":42,"countryCode":43,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Centre Eugène Marquis","Rennes","35042",{"type":45,"coordinates":178},[179,180],-1.67431,48.11109,{"lat":180,"lon":179},[183,185,187,189,191,193,195],{"name":184,"role":58,"phone":18,"phoneExt":18,"email":18},"Christophe PERRIN, MD",{"name":186,"role":30,"phone":18,"phoneExt":18,"email":18},"Marc PRACHT, MD",{"name":188,"role":58,"phone":18,"phoneExt":18,"email":18},"Angélique BRUNOT, MD",{"name":190,"role":58,"phone":18,"phoneExt":18,"email":18},"Astrid LIEVRE, PhD",{"name":192,"role":58,"phone":18,"phoneExt":18,"email":18},"Eugénie RIGAULT, MD",{"name":194,"role":58,"phone":18,"phoneExt":18,"email":18},"Thomas GRAINVILLE, MD",{"name":196,"role":58,"phone":18,"phoneExt":18,"email":18},"Anne-Sophie MOUSSADDAQ, MD",{"facility":198,"status":117,"city":199,"state":18,"zip":200,"country":42,"countryCode":43,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Institut de Cancérologie de l'Ouest - Site Réné Gauducheau","Saint-Herblain","44805",{"type":45,"coordinates":202},[203,204],-1.651,47.21154,{"lat":204,"lon":203},[207,209,210,212],{"name":208,"role":33,"phone":18,"phoneExt":18,"email":18},"Emanuelle BOMPAS",{"name":208,"role":30,"phone":18,"phoneExt":18,"email":18},{"name":211,"role":58,"phone":18,"phoneExt":18,"email":18},"Fréderic ROLLAND",{"name":213,"role":58,"phone":18,"phoneExt":18,"email":18},"Damien VANSTEENE",{"facility":215,"status":117,"city":216,"state":18,"zip":217,"country":42,"countryCode":43,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Institut de Cancérologie Lucien NEUWIRTH","Saint-Paul-en-Jarez","42270",{"type":45,"coordinates":219},[220,221],4.57113,45.48512,{"lat":221,"lon":220},[224,227,228],{"name":225,"role":33,"phone":18,"phoneExt":18,"email":226},"Olivier COLLARD, MD","Olivier.COLLARD@icloire.fr",{"name":225,"role":30,"phone":18,"phoneExt":18,"email":18},{"name":229,"role":58,"phone":18,"phoneExt":18,"email":18},"Cécile VASSAL, MD",{"facility":231,"status":117,"city":232,"state":18,"zip":233,"country":42,"countryCode":43,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Institut Claudius Regaud","Toulouse","31059",{"type":45,"coordinates":235},[236,237],1.44367,43.60426,{"lat":237,"lon":236},[240,243,244,246],{"name":241,"role":33,"phone":18,"phoneExt":18,"email":242},"Valentin THIBAUD","valentin.Thibaud@iuct-oncopole.fr",{"name":241,"role":30,"phone":18,"phoneExt":18,"email":18},{"name":245,"role":58,"phone":18,"phoneExt":18,"email":18},"Iphigénie KORAKIS",{"name":247,"role":58,"phone":18,"phoneExt":18,"email":18},"Christine CHEVREAU",{"facility":249,"status":117,"city":250,"state":18,"zip":251,"country":42,"countryCode":43,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Institut de Cancérologie de Lorraine","Vandœuvre-lès-Nancy","54519",{"type":45,"coordinates":253},[254,255],6.17114,48.66115,{"lat":255,"lon":254},[258,260],{"name":259,"role":33,"phone":18,"phoneExt":18,"email":18},"Maria RIOS, MD",{"name":259,"role":30,"phone":18,"phoneExt":18,"email":18},{"facility":262,"status":39,"city":263,"state":18,"zip":264,"country":42,"countryCode":43,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Institut Goustave Roussy","Villejuif","94805",{"type":45,"coordinates":266},[267,268],2.35992,48.7939,{"lat":268,"lon":267},[271,275,276,278,280],{"name":272,"role":33,"phone":273,"phoneExt":18,"email":274},"Axel LE CESNE, PhD","01 42 11 43 16","axel.lecesne@gustaveroussy.fr",{"name":272,"role":30,"phone":18,"phoneExt":18,"email":18},{"name":277,"role":58,"phone":18,"phoneExt":18,"email":18},"Rastislav BAHLEDA, MD",{"name":279,"role":58,"phone":18,"phoneExt":18,"email":18},"Olivier MIR, MD",{"name":281,"role":58,"phone":18,"phoneExt":18,"email":18},"Benjamin VERRET, MD",{"type":283,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100440025","phase-2-efficiency-of-imatinib-treatment-after-10-years-of-treatment-in-patients-with-gastrointestinal-stromal-tumours-gist-gist-ten-100440025",false,"NCT05009927","Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)","Randomized, Multicentre, Phase II Study Evaluating the Interest of Imatinib Treatment Maintenance or Interruption After at Least 10 Years of Treatment in Patients With Locally Advanced\u002FMetastatic Gastrointestinal Stromal Tumors (GISTs)","Inclusion Criteria:\n\n* Patients ≥18 years of age;\n* Histologically documented diagnosis of malignant advanced\u002Fmetastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;\n* Eastern Cooperative Oncology Group (ECOG) - Performance status (PS) 0 to 2 evaluated within 7 days prior to the date of inclusion.\n* Patient must be under imatinib treatment (at 300 or 400mg\u002Fday) maintained for 10 years or over with no more than 12 months in total or 3 consecutive months of interruption during the treatment period;\n* Patient with controlled disease (without any progression under imatinib);\n* Willingness and ability to comply with scheduled visits, treatment plans , laboratory tests, and other study procedures;\n* Covered by a medical\u002Fhealth insurance;\n* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.\n\nExclusion Criteria:\n\n* Patient concurrently using other approved or investigational antineoplastic agents;\n* Patient with GIST harboring the mutation D842V in PDGFRA;\n* Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;\n* Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years;\n* Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and\u002For concurrent medications\n* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection;\n* Major surgery within 2 weeks prior to study entry.\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n* Pregnant or breastfeeding woman\n* Patient requiring tutorship or curatorship or patient deprivied of liberty.","ALL","18 Years",{"count":294,"type":295},50,"ESTIMATED","INTERVENTIONAL",[298],"PHASE2","This is a 2 arms study concerning patients under imatinib treatment for at least 10 years of treatment with locally advanced\u002Fmetastatic GIST.\n\nIn the first arm, patients will discontinue Imatinib treatment. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease.\n\nIn the second arm, patients will continue Imatinib treatment, allowing to determine if the continuation of this treatment is efficient for disease control, by the rate of non-progression disease.",[301,302,303],"Metastatic Gastrointestinal Stromal Tumor (GIST)","C-KIT Mutation","Advanced Gastrointestinal Stromal Tumor (GIST)",[305,306,307,308,309,310,311],"Gastrointestinal Stromal Tumors (GIST)","Tyrosine kinase inhibitor","Maintenance therapy","Bayesian design","KIT +","Imatinib","Randomisation study","2023-08-31",{"date":314,"type":315},"2023-09-01","ACTUAL",{"date":317,"type":315},"2022-01-03",{"date":319,"type":295},"2027-01",{"name":5,"class":6},13]