[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659931":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":74,"studyPopulation":74,"armGroups":82,"interventions":93,"overallOfficials":74,"centralContacts":99,"locations":105,"responsibleParty":1077,"collaborators":1079,"id":1101,"slug":1102,"hasResults":1103,"nctId":1104,"briefTitle":1105,"officialTitle":1106,"acronym":1107,"eligibilityCriteria":1108,"healthyVolunteers":1103,"sex":1109,"minAge":1110,"maxAge":74,"enrollmentInfo":1111,"targetDuration":74,"studyType":1114,"phases":1115,"briefSummary":1117,"conditions":1118,"keywords":1124,"overallStatus":671,"whyStopped":74,"lastUpdateSubmitDate":1128,"lastUpdatePostDateStruct":1129,"startDateStruct":1132,"completionDateStruct":1134,"leadSponsor":1136,"locationsCount":1137},{"fullName":5,"class":6},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":74},[9,13],{"measure":10,"description":11,"timeFrame":12},"Part 1 of the study (Registration at diagnosis) : event-free survival (EFS)rate of the cohort overall different treatment sequences (First line of treatment) during 3 years .","EFS: time from diagnosis to the first occurrence of progression\u002Frelapse (local, regional, or distant), second primary malignancy, or death from any cause; events per investigator assessment with central review when available. Patients without an event are censored at the date of last follow-up.","3 years",{"measure":14,"description":15,"timeFrame":16},"Specific to FOSTER-CabOS (part-2), the first randomization question of the FOSTER evolving study platform: EFS of cabozantinib compared to best supportive care (BSC) as maintenance therapy after first-line chemotherapy","Considering EFS improvement in one or both of the following datasets :\n\n* patients in complete remission (CR) at the end of first-line therapy (stratum-1),\n* the whole randomised dataset, including patients with residual persistent stable disease after first-line treatment (non-resectable primary tumour, or metastatic disease not be completely resected), i.e. strata 1 and 2.\n\nEvent-free survival (EFS): time from randomisation to first recurrence or progression (local, regional or distant) based on central review evaluation, or death from any cause. A patient without an event is considered censored at his or her last follow-up date.","through study completion, an average of 8 year",[18,22,24,28,31,35,38,42,46,50,54,58,62,66,70],{"measure":19,"description":20,"timeFrame":21},"FOSTER evolving study platform (part 1): compliance with the first line conventional chemotherapy.","first line chemotherapy treatment delivery (dose intensity, delays, reductions, early discontinuation, reasons),","1 year",{"measure":23,"description":11,"timeFrame":21},"FOSTER evolving study platform (part 1): proportion of EFS and alive patients after the first line conventional chemotherapy.",{"measure":25,"description":26,"timeFrame":27},"FOSTER evolving study platform (part 1): the 3-year overall survival (OS) rate of the cohort overall, considering all treatment sequences.","Overall survival (OS): time from diagnosis to death from any cause","from diagnosis to 3 years",{"measure":29,"description":11,"timeFrame":30},"FOSTER evolving study platform (part 1): the 5-year event-free survival (EFS) rate of the cohort overall, considering all treatment sequences.","from diagnosis to 5 years",{"measure":32,"description":33,"timeFrame":34},"FOSTER evolving study platform (part 1) : adverse events under treatment sequences","Adverse events: incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and treatment-related mortality during induction.","from diagnosis to 8 years",{"measure":36,"description":37,"timeFrame":34},"FOSTER evolving study platform (part 1): quality of life (QoL) using validated instruments, including: EORTC QLQ C30,","Quality of life and functional outcome: QoL assessed by EORTC QLQ-C30",{"measure":39,"description":40,"timeFrame":41},"FOSTER Evolving study Platform (part 1): prognostic value of clinical and biological factors, including but not limited to the G1\u002FG2 signature determined at diagnosis, assessed by RNA sequencing or by simpler methods (e.g., IHC)","Prognostic factors: association of clinical and biological variables (including G1\u002FG2 signature at diagnosis) with OS and EFS via multivariable-adjusted Cox models.","at diagnosis",{"measure":43,"description":44,"timeFrame":45},"Specific for FOSTER-CabOS randomised trial (part-2): Adverse events (AE) of grade 3+, for patient under Cabozantinib, combined with mifamurtide","* Adverse events (AE), a real-time reporting of any AE of grade 3+ is planned during the first 8 weeks in the first 20 patients receiving mifamurtide.\n* The occurrence of cabozantinib related toxicities grade ≥3 within the first three months of treatment according to cabozantinib exposure.","from beginnning of Cabozantinib to 3 months after.",{"measure":47,"description":48,"timeFrame":49},"Specific for FOSTER-CabOS randomised trial (part-2): Q-TWiST and the net treatment benefit,","Quality-adjusted time without symptoms of disease or toxicity (Quality-adjusted Time Without Symptoms of disease recurrence or Toxicity (Q-TWiST)) computed from survival times (OS and Event Free Survival (EFS) duration) and adverse events data (duration of time spent with a severe-AE before progression\u002Frecurrence)","from the beginning of the part 2 to 8 years maximum",{"measure":51,"description":52,"timeFrame":53},"Specific for FOSTER-CabOS randomised trial (part-2): compliance of Cabozantinib","Feasibility and compliance: Cabozantinib compliance (dose taken)","from the beginning of cabozantinib to 12 cycles (of 28 days)",{"measure":55,"description":56,"timeFrame":57},"Specific for FOSTER-CabOS randomised trial (part-2): Event-Free Survival (EFS) according to clinical, radiological and biological factors, and treatment-by-subgroup interaction analyses assessing whether the effect of cabozantinib on EFS","i.e to define whether the treatment effect of Cabozantinib on EFS differs between subgroups of patients (disease status; histological response of the primary tumour; biological subgroups in particular G1\u002FG2 diagnostic RNAseq signature; type of first line chemotherapy; use of mifamurtide; age, metastatic status at diagnosis) Note that the determination of G1\u002FG2 signature requires the implementation of biology sample collections of the primary tumour.","at diagnostic to 12 cycles of cabozantinib (after randomization = 1 year)",{"measure":59,"description":60,"timeFrame":61},"Specific for FOSTER-CabOS randomised trial (part-2): IGF1 (Insuline-Like Growth Factor 1)","in paediatric patients \\\u003C 18 years with Tanner stage 1 to 2 at inclusion To evaluate whether cabozantinib affects the longitudinal growth in Pediatric population .","at baseline in part 2, End of treatment at 12 cycles, and every year until 8 years",{"measure":63,"description":64,"timeFrame":65},"Specific for FOSTER-CabOS randomised trial (part-2): wound healing","Vancouver Scare Scale: , range 0-13. Higher scores indicate worse scar characteristics and therefore a poorer outcome.","at baseline in part 2, every 3 months during the 12 cycles of cabozantinib, and End of Treatment (1 year).",{"measure":67,"description":68,"timeFrame":69},"FOSTER evolving study platform (part 1): quality of life (QoL) using validated instruments, including: PedQl,","Health- related QoL in patients \\\u003C18 uears will be assessed using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales","Baseline, every 3 months until 8 years",{"measure":71,"description":72,"timeFrame":73},"quality of life (QoL) using validated instruments, including: Functional outcome assessed by the Toronto Extremity Salvage Score (TESS).","The TESS is a patient-reported outcome measure developed to assess functional outcomes in patients who have undergone surgery, typically for bone or soft tissue tumors. It is used to evaluate the patient's ability to perform activities of daily living following surgery, focusing on areas such as mobility, self-care, and other daily activities.","from diagnosis to every 3 months during 8 years",null,{"allocation":76,"interventionModel":77,"interventionModelDescription":78,"primaryPurpose":79,"observationalModel":74,"timePerspective":74,"maskingInfo":80},"RANDOMIZED","PARALLEL","Part 2 of the FOSTER Evolving Study Platform: FOSTER-CabOS maintenance randomized trial: International randomised controlled phase 3 trial, comparing Cabozantinib versus the best supportive care as maintenance treatment, using a 2-parallel group design, :\n\n* Experimental group: Cabozantinib orally, 40 mg\u002Fm2\u002Fday (Max=60mg\u002Fday) x1\u002Fday, administered for 12 cycles of 28 days each maximum,\n* Control group: the best supportive care.","TREATMENT",{"masking":81,"maskingDescription":74,"whoMasked":74},"NONE",[83,89],{"label":84,"type":85,"description":86,"interventionNames":87},"Cabozantinib","EXPERIMENTAL","Cabozantinib orally, 40 mg\u002Fm2\u002Fday (Max=60mg\u002Fday) x1\u002Fday, administered for 12 cycles of 28 days each maximum",[88],"Drug: Experimental group : Cabometyx ® 40mg\u002Fm2\u002Fday (Max: 60mg\u002Fday) , Treatment schedule : Daily**, day 1-28 during 4 weeks (ie. 1 cycle) during 12 cycles",{"label":90,"type":91,"description":92,"interventionNames":74},"Best Supportive Care","NO_INTERVENTION","Best Supportive Care according to the country",[94],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":74},"DRUG","Experimental group : Cabometyx ® 40mg\u002Fm2\u002Fday (Max: 60mg\u002Fday) , Treatment schedule : Daily**, day 1-28 during 4 weeks (ie. 1 cycle) during 12 cycles","The intervention evaluated in FOSTER-CabOS is a maintenance treatment strategy using cabozantinib administered after completion of standard first-line therapy for newly diagnosed high-grade osteosarcoma. Unlike induction or salvage treatments, this intervention is introduced in patients without disease progression following standard treatment and aims to prevent or delay relapse. The study specifically evaluates the added value of 12 cycles of cabozantinib as maintenance therapy in a broad population of paediatric and adult osteosarcoma patients. This distinguishes the intervention from other osteosarcoma studies that typically focus on chemotherapy intensification, relapse treatment, or biomarker-selected population.",[84],[100],{"name":101,"role":102,"phone":103,"phoneExt":74,"email":104},"Nathalie GASPAR, Docteur","CONTACT","+33 1 42 11 41 66","nathalie.gaspar@gustaveroussy.fr",[106,123,133,146,159,174,184,197,210,223,236,251,264,277,290,300,313,326,339,352,365,378,391,404,417,427,440,453,466,479,489,499,512,525,538,548,561,574,587,600,610,623,633,646,659,669,680,695,708,721,734,747,760,770,783,798,811,824,837,852,867,880,893,903,916,929,942,955,968,983,992,1005,1018,1028,1041,1054,1067],{"facility":107,"status":108,"city":109,"state":74,"zip":74,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"Aarhus University Hospital, Department of Oncology","NOT_YET_RECRUITING","Aarhus","Denmark","DK",{"type":113,"coordinates":114},"Point",[115,116],10.21076,56.15674,{"lat":116,"lon":115},[119],{"name":120,"role":102,"phone":121,"phoneExt":74,"email":122},"Ninna AGGERHOLM PEDERSEN, Dr","+45 78454872","ninnpede@rm.dk",{"facility":124,"status":108,"city":109,"state":74,"zip":74,"country":110,"countryCode":111,"cosmosGeoPoint":125,"geoPoint":127,"contacts":128},"Aarhus University Hospital, Department of Paediatric and Adolescent Medicine",{"type":113,"coordinates":126},[115,116],{"lat":116,"lon":115},[129],{"name":130,"role":102,"phone":131,"phoneExt":74,"email":132},"Pernille WENDTLAND, Dr","+45 30715340","pern.edsl@rm.dk",{"facility":134,"status":108,"city":135,"state":74,"zip":74,"country":110,"countryCode":111,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Rigshospitalet, Copenhagen University Hospital, Department of Paediatric and Adolescent Medicine","Copenhagen",{"type":113,"coordinates":137},[138,139],12.56553,55.67594,{"lat":139,"lon":138},[142],{"name":143,"role":102,"phone":144,"phoneExt":74,"email":145},"Sascha WILK MICHELSEN, Dr","+45 35457457","sascha.wilk.michelsen.01@regionh.dk",{"facility":147,"status":108,"city":148,"state":74,"zip":74,"country":110,"countryCode":111,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Herlev Hospital, Department of Oncology","Herlev",{"type":113,"coordinates":150},[151,152],12.43998,55.72366,{"lat":152,"lon":151},[155],{"name":156,"role":102,"phone":157,"phoneExt":74,"email":158},"Niels JUNKER, Dr","+45 38682973","niels.junker@regionh.dk",{"facility":160,"status":108,"city":161,"state":74,"zip":74,"country":162,"countryCode":163,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"HUS-Yhtymae, Medical treatment and Clini-cal trial units","Helsinki","Finland","FI",{"type":113,"coordinates":165},[166,167],24.93545,60.16952,{"lat":167,"lon":166},[170],{"name":171,"role":102,"phone":172,"phoneExt":74,"email":173},"Sari Jäämaa","+358-50-4272703","sari.jaamaa@hus.fi",{"facility":175,"status":108,"city":161,"state":74,"zip":74,"country":162,"countryCode":163,"cosmosGeoPoint":176,"geoPoint":178,"contacts":179},"HUS-Yhtymae",{"type":113,"coordinates":177},[166,167],{"lat":167,"lon":166},[180],{"name":181,"role":102,"phone":182,"phoneExt":74,"email":183},"Jukka Kanerva","+358504279167","jukka.kanerva@hus.fi",{"facility":185,"status":108,"city":186,"state":74,"zip":74,"country":162,"countryCode":163,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Pohjois-Savon hyvinvointialue","Kuopio",{"type":113,"coordinates":188},[189,190],27.67703,62.89238,{"lat":190,"lon":189},[193],{"name":194,"role":102,"phone":195,"phoneExt":74,"email":196},"Tuuli Pöyhönen","+358447172395","tuuli.poyhonen@pshyvinvointialue.fi",{"facility":198,"status":108,"city":199,"state":74,"zip":74,"country":162,"countryCode":163,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Pohjois-Pohjanmaan hyvinvointialue","Oulu",{"type":113,"coordinates":201},[202,203],25.46816,65.01236,{"lat":203,"lon":202},[206],{"name":207,"role":102,"phone":208,"phoneExt":74,"email":209},"Ukonmaanaho Elli-Maija","+358505794405","elli-maija.ukonmaanaho@pohde.fi",{"facility":211,"status":108,"city":212,"state":74,"zip":74,"country":162,"countryCode":163,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Pirkanmaan hyvinvointialue","Tampere",{"type":113,"coordinates":214},[215,216],23.78712,61.49911,{"lat":216,"lon":215},[219],{"name":220,"role":102,"phone":221,"phoneExt":74,"email":222},"Susanna Vuorenoja","+358444728197","susanna.vuorenoja@pirha.fi",{"facility":224,"status":108,"city":225,"state":74,"zip":74,"country":162,"countryCode":163,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Varsinais-Suomen hyvinvointialue","Turku",{"type":113,"coordinates":227},[228,229],22.26869,60.45148,{"lat":229,"lon":228},[232],{"name":233,"role":102,"phone":234,"phoneExt":74,"email":235},"Anu Huurre","+ 3582318146","anu.huurre@varha.fi",{"facility":237,"status":108,"city":238,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"CHU Amiens Picardie - Site Sud","Amiens","France","FR",{"type":113,"coordinates":242},[243,244],2.3,49.9,{"lat":244,"lon":243},[247],{"name":248,"role":102,"phone":249,"phoneExt":74,"email":250},"Antoine GOURMEL, Dr","+33 3 22 08 76 50","Gourmel.Antoine@chu-amiens.fr",{"facility":252,"status":108,"city":253,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"CHU Angers","Angers",{"type":113,"coordinates":255},[256,257],-0.55202,47.47156,{"lat":257,"lon":256},[260],{"name":261,"role":102,"phone":262,"phoneExt":74,"email":263},"Stéphanie PROUST, dr","+33 2 41 35 38 63","stproust@chu-angers.fr",{"facility":265,"status":108,"city":266,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"CHRU Besançon - Hopital Jean Minjoz - Service d'Oncologie Médicale","Besançon",{"type":113,"coordinates":268},[269,270],6.01815,47.24878,{"lat":270,"lon":269},[273],{"name":274,"role":102,"phone":275,"phoneExt":74,"email":276},"Loic CHAIGNEAU, Dr","+33 3 70 63 24 03","lchaigneau@chu-besancon.fr",{"facility":278,"status":108,"city":279,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"CHU de Bordeaux - Groupe Hospitalier Pellegrin","Bordeaux",{"type":113,"coordinates":281},[282,283],-0.58046,44.84124,{"lat":283,"lon":282},[286],{"name":287,"role":102,"phone":288,"phoneExt":74,"email":289},"Cécile VERITE, Dr","+33 5 57 82 04 38","cecile.verite@chu-bordeaux.fr",{"facility":291,"status":108,"city":279,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":292,"geoPoint":294,"contacts":295},"Institut Bergonié",{"type":113,"coordinates":293},[282,283],{"lat":283,"lon":282},[296],{"name":297,"role":102,"phone":298,"phoneExt":74,"email":299},"Maud TOULMONDE, Dr","+33 5 56 33 33 33","m.toulmonde@bordeaux.unicancer.fr",{"facility":301,"status":108,"city":302,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"CHU Brest - Hôpital Morvan","Brest",{"type":113,"coordinates":304},[305,306],-4.48628,48.39029,{"lat":306,"lon":305},[309],{"name":310,"role":102,"phone":311,"phoneExt":74,"email":312},"Liana CARAUSU, Dr","+33 2 98 22 33 81","liana.carausu@chu-brest.fr",{"facility":314,"status":108,"city":315,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":316,"geoPoint":320,"contacts":321},"CHU Caen Normandie","Caen",{"type":113,"coordinates":317},[318,319],-0.35912,49.18585,{"lat":319,"lon":318},[322],{"name":323,"role":102,"phone":324,"phoneExt":74,"email":325},"Marianna DEPARIS, Dr","+33 2 31 06 44 88","deparis-m@chu-caen.fr",{"facility":327,"status":108,"city":328,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"CHU François Mitterrand","Dijon",{"type":113,"coordinates":330},[331,332],5.01391,47.31344,{"lat":332,"lon":331},[335],{"name":336,"role":102,"phone":337,"phoneExt":74,"email":338},"Florent NEUMANN, Dr","+33 3 80 29 36 01","florent.neumann@chu-dijon.fr",{"facility":340,"status":108,"city":341,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"CHU Grenoble, Hôpital Couple-enfant","Grenoble",{"type":113,"coordinates":343},[344,345],5.71479,45.17869,{"lat":345,"lon":344},[348],{"name":349,"role":102,"phone":350,"phoneExt":74,"email":351},"Séverine BOBILLIER-CHAUMONT, Dr","+33 4 76 76 49 54","Sbobillierchaumont@chu-grenoble.fr",{"facility":353,"status":108,"city":354,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":355,"geoPoint":359,"contacts":360},"CHU de La Réunion","La Réunion",{"type":113,"coordinates":356},[357,358],1.98063,43.48994,{"lat":358,"lon":357},[361],{"name":362,"role":102,"phone":363,"phoneExt":74,"email":364},"Stéphanie GOURDON, Dr","+ 262 262 90 61 10","stephanie.gourdon@chu-reunion.fr",{"facility":366,"status":108,"city":367,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":368,"geoPoint":372,"contacts":373},"Centre Oscar Lambret","Lille",{"type":113,"coordinates":369},[370,371],3.05512,50.63391,{"lat":371,"lon":370},[374],{"name":375,"role":102,"phone":376,"phoneExt":74,"email":377},"Cyril LERVAT, Dr","+33 3 20 29 59 59","c-lervat@o-lambret.fr",{"facility":379,"status":108,"city":380,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":381,"geoPoint":385,"contacts":386},"CHU Limoges","Limoges",{"type":113,"coordinates":382},[383,384],1.24759,45.83362,{"lat":384,"lon":383},[387],{"name":388,"role":102,"phone":389,"phoneExt":74,"email":390},"Christophe PIGUET, Dr","+33 5 55 05 68 01","christophe.piguet@chu-limoges.fr",{"facility":392,"status":108,"city":393,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":394,"geoPoint":398,"contacts":399},"Centre Léon Bérard","Lyon",{"type":113,"coordinates":395},[396,397],4.84789,45.74906,{"lat":397,"lon":396},[400],{"name":401,"role":102,"phone":402,"phoneExt":74,"email":403},"Medhi BRAHMI, Dr","+33 4 78 78 27 57","Mehdi.BRAHMI@lyon.unicancer.fr",{"facility":405,"status":108,"city":406,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":407,"geoPoint":411,"contacts":412},"Hopital de la Timone - Service d'Hématologie et Oncologie Pédiatrique","Marseille",{"type":113,"coordinates":408},[409,410],5.38107,43.29695,{"lat":410,"lon":409},[413],{"name":414,"role":102,"phone":415,"phoneExt":74,"email":416},"Gabriel REVON-RIVIERE, Dr","+33 4 91 38 68 21","gabriel.revon-riviere@ap-hm.fr",{"facility":418,"status":108,"city":406,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":419,"geoPoint":421,"contacts":422},"Hopital de la Timone - Service d'Oncologie médicale",{"type":113,"coordinates":420},[409,410],{"lat":410,"lon":409},[423],{"name":424,"role":102,"phone":425,"phoneExt":74,"email":426},"Florence DUFFAUD, Pr","+33 4 91 38 73 77","florence.duffaud@ap-hm.fr",{"facility":428,"status":108,"city":429,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":430,"geoPoint":434,"contacts":435},"CHU Arnaud de Villeneuve","Montpellier",{"type":113,"coordinates":431},[432,433],3.87635,43.61093,{"lat":433,"lon":432},[436],{"name":437,"role":102,"phone":438,"phoneExt":74,"email":439},"Stéphanie HAOUY, Dr","+33 4 67 33 65 19","s-haouy@chu-montpellier.fr",{"facility":441,"status":108,"city":442,"state":74,"zip":74,"country":239,"countryCode":240,"cosmosGeoPoint":443,"geoPoint":447,"contacts":448},"CHU Nantes - Hôpital Femme-Enfant-Adolescent","Nantes",{"type":113,"coordinates":444},[445,446],-1.55336,47.21725,{"lat":446,"lon":445},[449],{"name":450,"role":102,"phone":451,"phoneExt":74,"email":452},"Morgane CLEIREC, Dr","+33 2 40 08 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Kanker",{"name":1096,"class":1082},"Fundacion Cientifica de la Asociacion Española contra el Cancer",{"name":1098,"class":1082},"Donase foundation",{"name":1100,"class":1082},"FOSTER consortium","100659931","phase-3-fight-osteosarcoma-through-european-research-evolving-study-platform-from-diagnosis-to-relapse-100659931",false,"NCT07871864","Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse","FOSTER Evolving Study Platform","FOSTER","REGISTRATION in FOSTER-Evolving study platfom, Part-1:\n\nInclusion Criteria :\n\n1. Newly diagnosed, biopsy-proven, high-grade osteosarcoma,\n2. Patient considered medically fit to receive systemic treatment,\n3. Planned systemic therapy according to national guidelines and age\n4. Written informed consent from patients or for minor, from their parents\u002F legal representatives, before enrolment and any study-related procedure.\n5. Affiliation to a social insurance or equivalent regimen (if required in the country).\n\nExclusion Criteria:\n\n1\\. Low-grade osteosarcoma, parosteal or periosteal osteosarcoma, small cell osteosarcoma\n\nFOR FOSTER-CabOS RANDOMISATION (part-2) :\n\n1. Patient with a histologically proven and confirmed high-grade osteosarcoma, according to the criteria described in the last World Health Organization (WHO) classification of Soft Tissue and Bone Tumours, after the exclusion of all potential differential diagnoses, either by local pathologists with expertise in bone sarcomas, or through centralized revision in a referral centre, according to national rules.\n2. Age ≥ 4 years old (when able to swallow tablet) ; no upper age limit\n3. First line systemic and local treatment of primary tumour (and metastasis when present) for localised or metastatic osteosarcoma must have been completed according to national guidelines (Mifamurtide is allowed according to centre's practices)\n4. Recovery to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5 Grade 0 or 1 level or recovery to baseline health status preceding the prior treatment from any previous drug\u002Fprocedure related toxicity (except alopecia, anaemia, and hypothyroidism)\n5. Performance status \\\u003C 2 for patient adult, or \\>70 using Karnofsky or Lansky performance scores.\n6. Interval between the last treatment either chemotherapy administration or surgical procedures or radiotherapy or thermoablation, (whichever occurred last) and the date of randomisation should be at least 4 weeks but no longer than 2 months;\n7. Disease in complete remission or with residual persistent stable disease according to RECIST criteria before randomisation (please refer 7.3.4 for the definition of the residual persistent stable disease )\n8. Patient fit to undergo protocol treatment and follow-up\n9. Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥50% and\u002For fractional shortening (FS) \\>28% at baseline as determined by echocardiography or multigated acquisition (MUGA) scan (performed only if echocardiography is not feasible)\n10. Adequately controlled blood pressure (BP) with or without antihypertensive medications: BP 95th percentile for sex, age and height\u002Flength at screening (as per NHLBI (National Heart, Lung and Blood Institute) guidelines) and no change in antihypertensive medications within 1 week prior to start of treatment (C1D1). Patients aged \\>18 years should have a BP ≤150\u002F90 mmHg at screening and no change in antihypertensive therapy within 1 week prior to C1D1\n11. Screening laboratory values must meet the following criteria (according to CTCAE v5) and should be obtained within 7 days prior to randomisation\n\n    * Absolute neutrophil count ≥ 1 x 109\u002FL\n    * Platelets ≥ 100 x 109\u002FL\n    * Haemoglobin ≥ 8.0 g\u002FdL (a hemoglobin of less than 8.0 g\u002Fdl is acceptable if it is corrected by growth factor or transfusion before C1D1)\n    * Serum creatinine ≤ 1.5 x ULN or based on age\u002Fgender. If serum creatinine is greater than maximum serum creatinine for age\u002Fgender as described, then creatinine clearance (or radioisotope Glomerular Filtration Rate (GFR)) must be \\>60 ml\u002Fmin\u002F1.73 m2\n    * Urine dipstick \\\u003C 2+ for proteinuria. Patients who have ≥2+ proteinuria on dipstick urinalysis should undergo a spot Protein\u002FCreatinine ratio test that should be grade 2 (less or equal) per CTCAE v5.0\n    * No clinical evidence of nephrotic syndrome\n    * Alanine Aminotransferase\u002FAspartate Aminotransferase (ALT\u002FAST) ≤ 2.5 x Upper limit of normal (ULN) in the absence of liver metastases or ≤ 5.0 x ULN in the presence of liver metastases\n    * Total bilirubin ≤ 1.5 x ULN (except Gilbert Syndrome: \\\u003C 3.0 mg\u002FdL) or ≤ 5.0 x ULN in the presence of liver metastases\n    * Alkaline phosphatase (PAL) ≤2.5 x ULN (≤5 x ULN in patient with liver involvement of their cancer). If Alkaline phosphatase \\> 2.5 ULN, Gamma-Glutamyl Transferase GGT tests must be performed; GGT \\\u003C 1.5 x ULN\n    * Lipase ≤1.5 x ULN\n    * INR (International Normalized Ratio) \u002FPTT (Partial Thromboplatin Time) ≤1.5 x ULN\n12. Patients who are therapeutically treated with an agent such as warfarin or heparin\u002F Low-molecular-weight heparin (LMWH) will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists.\n13. Women of childbearing potential or young women of childbearing potential and who started their puberty (menarche) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of Human Chorionic Gonadotropin (HCG)) done within 7 days prior to randomisation.\n14. Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy. Because oral contraceptives might not be considered as \"effective methods of contraception\", they should be used together with another method, such as a barrier method, according to age and gynaecologist advice\n15. Provision of dated and signed written informed consent from patients or for minor, from their parents\u002F legal representatives, for the randomised trial prior to any study specific procedures, sampling and analyses..\n16. Affiliation to a social insurance or equivalent regimen (if required in the country).","ALL","4 Years",{"count":1112,"type":1113},530,"ESTIMATED","INTERVENTIONAL",[1116],"PHASE3","This clinical study is the initiative of the FOSTER (Fight OsteoSarcoma Through European Research) consortium and Gustave Roussy, which is the sponsor. Its aim is to evaluate the biology of tumour in greater depth by collecting samples of the tumour during the biopsy at diagnosis, and blood samples. This study is a platform study that evolves over time. This means that it allows for the evaluation of several treatments or therapeutic strategies within a single clinical trial, which can be modified and adapted over time.\n\nThe FOSTER evolving study platform aim to implement a comprehensive strategy of clinical, biological, radiological, therapeutic integrated research from diagnosis to relapse, with the aim to improve survival of osteosarcoma patients of all age, through randomised therapeutic questions at different phase of treatment from diagnosis to relapse. The platform study makes it possible to evaluate several treatments for the same disease, on an ongoing basis, using a main protocol with adaptable arms.\n\nThe FOSTER-CabOS trial (part 2 of FOSTER study) is a European Phase III clinical study . It assesses the efficacy of cabozantinib, a tyrosine kinase inhibitor, as a maintenance therapy post-standard treatment in osteosarcoma patients. The trial is randomized against Best Supportive Care to determine the effectiveness of cabozantinib in improving event-free survival. This maintenance therapy aims to prevent relapse among patients who have already received standard treatment for osteosarcoma.",[1119,1120,1121,1122,1123],"Osteosarcoma","Pediatric Osteosarcoma","Osteosarcoma in Children","Osteosarcoma in Adolescents and Young Adults","Osteosarcoma Metastatic",[1125,1107,1126,1127],"platform trial","osteosarcoma patients","Paediatrics and adults patients with high-grade osteosarcoma","2026-10-06",{"date":1130,"type":1131},"2026-10-13","ACTUAL",{"date":1133,"type":1113},"2026-10",{"date":1135,"type":1113},"2036-01",{"name":5,"class":6},77]