OsteosarcomaPhase 3FOSTERNCT07871864
Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse
A Phase 3 study testing Experimental group : Cabometyx ® 40mg/m2/day (Max: 60mg/day) , Treatment schedule : Daily**, day 1-28 during 4 weeks (ie. 1 cycle) during 12 cycles in people with Osteosarcoma and Pediatric Osteosarcoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 77 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Osteosarcoma, Pediatric Osteosarcoma, Osteosarcoma in Children
- What is being tested?
- Experimental group : Cabometyx ® 40mg/m2/day (Max: 60mg/day) , Treatment schedule : Daily**, day 1-28 during 4 weeks (ie. 1 cycle) during 12 cycles
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 77 sitesin 8 countries
- Study dates
- Oct 2026to Jan 2036
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed, biopsy-proven, high-grade osteosarcoma,
- Patient considered medically fit to receive systemic treatment,
- Planned systemic therapy according to national guidelines and age
- Written informed consent from patients or for minor, from their parents/ legal representatives, before enrolment and any study-related procedure.
- Affiliation to a social insurance or equivalent regimen (if required in the country).
Who cannot join
- 1. Low-grade osteosarcoma, parosteal or periosteal osteosarcoma, small cell osteosarcoma
- FOR FOSTER-CabOS RANDOMISATION (part-2) :
- 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.
- Age ≥ 4 years old (when able to swallow tablet) ; no upper age limit
- 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)
- 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/procedure related toxicity (except alopecia, anaemia, and hypothyroidism)
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- Performance status < 2 for patient adult, or >70 using Karnofsky or Lansky performance scores.
- 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;
- 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 )
- Patient fit to undergo protocol treatment and follow-up
- Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥50% and/or fractional shortening (FS) >28% at baseline as determined by echocardiography or multigated acquisition (MUGA) scan (performed only if echocardiography is not feasible)
- Adequately controlled blood pressure (BP) with or without antihypertensive medications: BP 95th percentile for sex, age and height/length 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 ≤150/90 mmHg at screening and no change in antihypertensive therapy within 1 week prior to C1D1
- Screening laboratory values must meet the following criteria (according to CTCAE v5) and should be obtained within 7 days prior to randomisation
- Absolute neutrophil count ≥ 1 x 109/L
- Platelets ≥ 100 x 109/L
- Haemoglobin ≥ 8.0 g/dL (a hemoglobin of less than 8.0 g/dl is acceptable if it is corrected by growth factor or transfusion before C1D1)
- Serum creatinine ≤ 1.5 x ULN or based on age/gender. If serum creatinine is greater than maximum serum creatinine for age/gender as described, then creatinine clearance (or radioisotope Glomerular Filtration Rate (GFR)) must be >60 ml/min/1.73 m2
- Urine dipstick < 2+ for proteinuria. Patients who have ≥2+ proteinuria on dipstick urinalysis should undergo a spot Protein/Creatinine ratio test that should be grade 2 (less or equal) per CTCAE v5.0
- No clinical evidence of nephrotic syndrome
- Alanine Aminotransferase/Aspartate Aminotransferase (ALT/AST) ≤ 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
- Total bilirubin ≤ 1.5 x ULN (except Gilbert Syndrome: < 3.0 mg/dL) or ≤ 5.0 x ULN in the presence of liver metastases
- 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 < 1.5 x ULN
- Lipase ≤1.5 x ULN
- INR (International Normalized Ratio) /PTT (Partial Thromboplatin Time) ≤1.5 x ULN
- Patients who are therapeutically treated with an agent such as warfarin or heparin/ Low-molecular-weight heparin (LMWH) will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists.
- 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/L or equivalent units of Human Chorionic Gonadotropin (HCG)) done within 7 days prior to randomisation.
- 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
- Provision of dated and signed written informed consent from patients or for minor, from their parents/ legal representatives, for the randomised trial prior to any study specific procedures, sampling and analyses..
- Affiliation to a social insurance or equivalent regimen (if required in the country).
Trial locations and contacts
77 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
77 sites in 8 countries
France36 sites, 36 recruiting
- Not yet recruiting
CHU Amiens Picardie - Site Sud
Amiens
Antoine GOURMEL, Dr, +33 3 22 08 76 50, Gourmel.Antoine@chu-amiens.fr
- Not yet recruiting
CHU Angers
Angers
Stéphanie PROUST, dr, +33 2 41 35 38 63, stproust@chu-angers.fr
- Not yet recruiting
CHRU Besançon - Hopital Jean Minjoz - Service d'Oncologie Médicale
Besançon
Loic CHAIGNEAU, Dr, +33 3 70 63 24 03, lchaigneau@chu-besancon.fr
- Not yet recruiting
CHU de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux
Cécile VERITE, Dr, +33 5 57 82 04 38, cecile.verite@chu-bordeaux.fr
- Not yet recruiting
Institut Bergonié
Bordeaux
Maud TOULMONDE, Dr, +33 5 56 33 33 33, m.toulmonde@bordeaux.unicancer.fr
- Not yet recruiting
CHU Brest - Hôpital Morvan
Brest
Liana CARAUSU, Dr, +33 2 98 22 33 81, liana.carausu@chu-brest.fr
- Not yet recruiting
CHU Caen Normandie
Caen
Marianna DEPARIS, Dr, +33 2 31 06 44 88, deparis-m@chu-caen.fr
- Not yet recruiting
CHU François Mitterrand
Dijon
Florent NEUMANN, Dr, +33 3 80 29 36 01, florent.neumann@chu-dijon.fr
- Not yet recruiting
CHU Grenoble, Hôpital Couple-enfant
Grenoble
Séverine BOBILLIER-CHAUMONT, Dr, +33 4 76 76 49 54, Sbobillierchaumont@chu-grenoble.fr
- Not yet recruiting
CHU de La Réunion
La Réunion
Stéphanie GOURDON, Dr, + 262 262 90 61 10, stephanie.gourdon@chu-reunion.fr
- Not yet recruiting
Centre Oscar Lambret
Lille
Cyril LERVAT, Dr, +33 3 20 29 59 59, c-lervat@o-lambret.fr
- Not yet recruiting
CHU Limoges
Limoges
Christophe PIGUET, Dr, +33 5 55 05 68 01, christophe.piguet@chu-limoges.fr
- Not yet recruiting
Centre Léon Bérard
Lyon
Medhi BRAHMI, Dr, +33 4 78 78 27 57, Mehdi.BRAHMI@lyon.unicancer.fr
- Not yet recruiting
Hopital de la Timone - Service d'Hématologie et Oncologie Pédiatrique
Marseille
Gabriel REVON-RIVIERE, Dr, +33 4 91 38 68 21, gabriel.revon-riviere@ap-hm.fr
- Not yet recruiting
Hopital de la Timone - Service d'Oncologie médicale
Marseille
Florence DUFFAUD, Pr, +33 4 91 38 73 77, florence.duffaud@ap-hm.fr
- Not yet recruiting
CHU Arnaud de Villeneuve
Montpellier
Stéphanie HAOUY, Dr, +33 4 67 33 65 19, s-haouy@chu-montpellier.fr
- Not yet recruiting
CHU Nantes - Hôpital Femme-Enfant-Adolescent
Nantes
Morgane CLEIREC, Dr, +33 2 40 08 36 10, morgane.cleirec@chu-nantes.fr
- Not yet recruiting
CHU Nice
Nice
Joy BENADIBA, Dr, +33 4 92 03 92 68, benadiba.j@chu-nice.fr
- Not yet recruiting
Hôpital Armand Trousseau
Paris
Marie-Dominique TABONE, Dr, +33 1 44 73 68 46, marie-dominique.tabone@aphp.fr
- Not yet recruiting
Hôpital Cochin
Paris
Camille TLEMSANI, Pr, +33 1 58 41 19 26, camille.tlemsani@aphp.fr
- Not yet recruiting
Institut Curie
Paris
Sophie PIPERNO-NEUMANN, Dr, +33 1 44 32 40 68, sophie.piperno-neumann@curie.fr
- Not yet recruiting
CHU Poitiers
Poitiers
Chrystelle DUPRAZ, Dr, +33 5 49 44 33 02, Chrystelle.DUPRAZ@chu-poitiers.fr
- Not yet recruiting
CHU Reims
Reims
Grégory GUIMARD, Dr, +33 3 26 78 35 53, gguimard@chu-reims.fr
- Not yet recruiting
Centre Eugène Marquis
Rennes
Xavier CHODERLOS DE LACLOS, Dr, +33 2 99 25 31 13, x.choderlos-de-laclos@rennes.unicancer.fr
- Not yet recruiting
CHU Rennes Hôpital Sud
Rennes
Jamie PROBERT, Dr, +33 2 99 26 58 35, jamie.probert@chu-rennes.fr
- Not yet recruiting
CHU Charles Nicolle
Rouen
Aude MARIE-CARDINE, Dr, +33 2 32 88 07 14, aude.marie-cardine@chu-rouen.fr
- Not yet recruiting
CHU Saint-Etienne - Hôpital Nord
Saint-Etienne
Faustine TARDY, Dr, +33 4 77 82 88 08, Faustine.tardy@chu-st-etienne.fr
- Not yet recruiting
Institut de Cancérologie de l'Ouest - Site Saint-Herblain
Saint-Herblain
Emmanuelle BOMPAS, Dr, +33 2 40 67 99 00, emmanuelle.bompas@ico.unicancer.fr
- Not yet recruiting
Centre Paul Strauss
Strasbourg
Teresa AMARAL, Dr., +33 3 68 76 68 70, t.amaral@icans.eu
- Not yet recruiting
Hopital de Hautepierre
Strasbourg
Natacha ENTZ-WERLE, Pr, +33 3 88 12 83 89, natacha.entz-werle@chru-strasbourg.fr
- Not yet recruiting
CHU Toulouse - Hôpital des enfants
Toulouse
Marie-Pierre CASTEX, Dr, +33 5 34 55 86 10, castex.mp@chu-toulouse.fr
- Not yet recruiting
Oncopole Claudius Regaud-IUCT Oncopole
Toulouse
Thibaud VALENTIN, Dr, +33 5 31 15 51 51, valentin.thibaud@iuct-oncopole.fr
- Not yet recruiting
CHU Tours, Hôpital Bretonneau
Tours
Bérangère NARCISO, Dr, +33 2 47 47 99 19, b.narciso-raharimanana@chu-tours.fr
- Not yet recruiting
CHRU Nancy, Hôpital d'enfants
Vandœuvre-lès-Nancy
Ludovic MANSUY, Dr, +33 3 83 15 47 34, lu.mansuy@chru-nancy.fr
- Not yet recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Anne KIEFFER, Dr, +33 3 83 59 85 64, a.kieffer@nancy.unicancer.fr
- Recruiting
Gustave Roussy
Villejuif
Nathalie GASPAR, Docteur, +33 1 42 11 41 66, nathalie.gaspar@gustaveroussy.fr
Spain9 sites, 9 recruiting
- Not yet recruiting
Hospital Universitario Cruces
Barakaldo
Aizpea ECHEBARRIA, 34 94 600 6289, aizpeabeatriz.echebarriabarona@osakidetza.eus
- Not yet recruiting
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona
Claudia VALVERDE MORALES, 34 93 274 60 00, cvalverde@vhio.net
- Not yet recruiting
Hospital General Universitario Gregorio Marañón, Pediatric and adolescent onco-haematology unit
Madrid
Cristina MATA, 34 91 529 00 37, cristina.mata@salud.madrid.org
- Not yet recruiting
Hospital Universitario del Niño Jesús
Madrid
Alba Rubio San Simón, 34 915 03 59 00, alba.rubio@salud.madrid.org
- Not yet recruiting
Hospital Virgen de la Arrixaca
Murcia
Esther LLINARES RIESTRA, 34 968 36 92 97, mariae.llinares@carm.es
- Not yet recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Josefina CRUZ JURADO, 34 922 67 73 51, jcruzjur@gobiernodecanarias.org
- Not yet recruiting
Hospital Universitario Virgen del Rocío
Seville
Catalina Márquez Vega, 34 607 93 76 77, catalina.marquez.sspa@juntadeandalucia.es
- Not yet recruiting
Hospital Universitari i Politècnic La Fe
Valencia
Antonio JUAN RIBELLES, 34 961 24 40 00, juan_antrib@gva.es
- Not yet recruiting
Hospital Universitario Miguel Servet
Zaragoza
Javier MARTINEZ TRUFERO, 34 976 76 55 00, jmartinezt@salud.aragon.es
Sweden9 sites, 9 recruiting
- Not yet recruiting
Sahlgrenska University Hospital , pediatric
Gothenburg
Petra WIEVEG, 46 31 342 10 00, petra.wieveg@vgregion.se
- Not yet recruiting
Sahlgrenska University Hospital
Gothenburg
Torben Ek, 46 31 342 10 00, torben.ek@vgregion.se
- Not yet recruiting
Linköping University Hospital
Linköping
Hagen GRAF VON EINSIEDEL, 46 10 1034599, hagen.graf.von.einsiedel@regionostergotland.se
- Not yet recruiting
Skåne University Hospital , oncology for adults
Lund
Marie AHLSTRÖM, 46-70-6823658, marie.ahlstrom@skane.se
- Not yet recruiting
Skåne University Hospital
Lund
Anders VALIND, 46-46178993, anders.valind@skane.se
- Not yet recruiting
Karolinska University Hospital
Stockholm
Fredrik BAECKLUND, 46-70-7575572, fredrik.baecklund@regionstockholm.se
- Not yet recruiting
Norrlands University Hospital
Umeå
Caroline BJÖRKLUND, 4690-785 02 50, caroline.bjorklund@regionvasterbotten.se
- Not yet recruiting
Uppsala University Hospital , oncology for pediatrics
Uppsala
Catarina TRÄGER, 46-72-3353032, catarina.trager@akademiska.se
- Not yet recruiting
Uppsala University Hospital
Uppsala
Sharmineh MANSOORI, 46-736855944, sharmineh.mansoori.moghaddam@Akademiska.se
Italy8 sites, 8 recruiting
- Not yet recruiting
IRCCS Istituto Ortopedico Rizzoli (Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit)
Bologna
Toni Ibrahim, +39 0516366199, toni.ibrahim@ior.it
- Not yet recruiting
IRCCS Giannina Gaslini (Oncology Unit)
Genova
Carla Manzitti, +3901056363526, carlamanzitti@gaslini.org
- Not yet recruiting
Fondazione IRCC Istituto Nazionale dei Tumori, Milano (Pediatric Oncology Unit)
Milan
Cristina Meazza, +390223902588, cristina.meazza@istitutotumori.mi.it
- Not yet recruiting
Azienda Ospedale - Università Padova (Pediatric Oncohematology Unit)
Padova
Marta Pierobon, +390498217436, marta.pierobon@aopd.vento.it
- Not yet recruiting
AOUP Azienda Ospedaliera Universitaria Pisana (Pediatric Onco-Hematology Unit)
Pisa
Luca Coccoli, +39 050992840, l.coccoli@ao-pisa.toscana.it
- Not yet recruiting
IRCCS Istituto Nazionale Tumori Regina Elena (Experimental Clinic for Sarcomas, Rare Tumors, and Melanoma Unit)
Roma
Virginia Ferraresi, +390652665144, virgina.ferraresi@ifo.it
- Not yet recruiting
IRCCS Ospedale Pediatrico Bambino Gesù (Division of Pediatric Hematology and Oncology, Gene and Cellular Therapy)
Roma
Giuseppe Maria Milano, +39 0668594151, giuseppemaria.milano@opbg.net
- Not yet recruiting
Ospedale Infantile Regina Margherita - AOU Città della Salute e della Scienza (Pediatric Onco-Hematology Unit)
Torino
Franca Fagioli, +390113135230, franca.fagioli@unito.it
Finland6 sites, 6 recruiting
- Not yet recruiting
HUS-Yhtymae, Medical treatment and Clini-cal trial units
Helsinki
Sari Jäämaa, +358-50-4272703, sari.jaamaa@hus.fi
- Not yet recruiting
HUS-Yhtymae
Helsinki
Jukka Kanerva, +358504279167, jukka.kanerva@hus.fi
- Not yet recruiting
Pohjois-Savon hyvinvointialue
Kuopio
Tuuli Pöyhönen, +358447172395, tuuli.poyhonen@pshyvinvointialue.fi
- Not yet recruiting
Pohjois-Pohjanmaan hyvinvointialue
Oulu
Ukonmaanaho Elli-Maija, +358505794405, elli-maija.ukonmaanaho@pohde.fi
- Not yet recruiting
Pirkanmaan hyvinvointialue
Tampere
Susanna Vuorenoja, +358444728197, susanna.vuorenoja@pirha.fi
- Not yet recruiting
Varsinais-Suomen hyvinvointialue
Turku
Anu Huurre, + 3582318146, anu.huurre@varha.fi
Denmark4 sites, 4 recruiting
- Not yet recruiting
Aarhus University Hospital, Department of Oncology
Aarhus
Ninna AGGERHOLM PEDERSEN, Dr, +45 78454872, ninnpede@rm.dk
- Not yet recruiting
Aarhus University Hospital, Department of Paediatric and Adolescent Medicine
Aarhus
Pernille WENDTLAND, Dr, +45 30715340, pern.edsl@rm.dk
- Not yet recruiting
Rigshospitalet, Copenhagen University Hospital, Department of Paediatric and Adolescent Medicine
Copenhagen
Sascha WILK MICHELSEN, Dr, +45 35457457, sascha.wilk.michelsen.01@regionh.dk
- Not yet recruiting
Herlev Hospital, Department of Oncology
Herlev
Niels JUNKER, Dr, +45 38682973, niels.junker@regionh.dk
Netherlands4 sites, 4 recruiting
- Not yet recruiting
University Medical Center Groningen
Groningen
Jacco J DE HAAN, 31 50 361 2821, j.j.de.haan@umcg.nl
- Not yet recruiting
Leiden University Medical Center
Leiden
Hans GELDERBLOM, Pr, 31 71 526 3486, a.j.gelderblom@lumc.nl
- Not yet recruiting
Radboud University Medical Center
Nijmegen
Suzan KAAL, +31 24 361 1111, Suzanne.Kaal@radboudumc.nl
- Not yet recruiting
Princess Maxima Center for Pediatric Oncology
Utrecht
Roelof van EWIJK, Pr, +31 88 972 7272, r.vanewijk-2@prinsesmaximacentrum.nl
Poland1 site, 1 recruiting
- Not yet recruiting
Instytut Matki i Dziecka
Warsaw
Anna RACIBORSKA, 48 22 32 77 205, anna.raciborska@hoga.pl
About this study
Official title: FOSTER Evolving Study Platform
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.
The 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.
The 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.
- Conditions
- Osteosarcoma, Pediatric Osteosarcoma, Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults, Osteosarcoma Metastatic
- Being tested
- Experimental group : Cabometyx ® 40mg/m2/day (Max: 60mg/day) , Treatment schedule : Daily**, day 1-28 during 4 weeks (ie. 1 cycle) during 12 cycles
- Keywords
- platform trial, FOSTER, osteosarcoma patients, Paediatrics and adults patients with high-grade osteosarcoma
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group : Cabometyx ® 40mg/m2/day (Max: 60mg/day) , Treatment schedule : Daily**, day 1-28 during 4 weeks (ie. 1 cycle) during 12 cyclesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cabozantinib | Experimental | Cabozantinib orally, 40 mg/m2/day (Max=60mg/day) x1/day, administered for 12 cycles of 28 days each maximum Receives: Drug: Experimental group : Cabometyx ® 40mg/m2/day (Max: 60mg/day) , Treatment schedule : Daily**, day 1-28 during 4 weeks (ie. 1 cycle) during 12 cycles |
| Best Supportive Care | No intervention | Best Supportive Care according to the country |
What is being measured
The primary outcome is the main question the study is designed to answer.
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/relapse (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.
Measured: 3 years
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 :
- patients in complete remission (CR) at the end of first-line therapy (stratum-1),
- 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.
Event-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.
Measured: through study completion, an average of 8 year
Secondary outcomes (15)
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),
Measured: 1 year
FOSTER evolving study platform (part 1): proportion of EFS and alive patients after the first line conventional chemotherapy.
EFS: time from diagnosis to the first occurrence of progression/relapse (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.
Measured: 1 year
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
Measured: from diagnosis to 3 years
FOSTER evolving study platform (part 1): the 5-year event-free survival (EFS) rate of the cohort overall, considering all treatment sequences.
EFS: time from diagnosis to the first occurrence of progression/relapse (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.
Measured: from diagnosis to 5 years
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.
Measured: from diagnosis to 8 years
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
Measured: from diagnosis to 8 years
FOSTER Evolving study Platform (part 1): prognostic value of clinical and biological factors, including but not limited to the G1/G2 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/G2 signature at diagnosis) with OS and EFS via multivariable-adjusted Cox models.
Measured: at diagnosis
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.
- The occurrence of cabozantinib related toxicities grade ≥3 within the first three months of treatment according to cabozantinib exposure.
Measured: from beginnning of Cabozantinib to 3 months after.
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/recurrence)
Measured: from the beginning of the part 2 to 8 years maximum
Specific for FOSTER-CabOS randomised trial (part-2): compliance of Cabozantinib
Feasibility and compliance: Cabozantinib compliance (dose taken)
Measured: from the beginning of cabozantinib to 12 cycles (of 28 days)
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/G2 diagnostic RNAseq signature; type of first line chemotherapy; use of mifamurtide; age, metastatic status at diagnosis) Note that the determination of G1/G2 signature requires the implementation of biology sample collections of the primary tumour.
Measured: at diagnostic to 12 cycles of cabozantinib (after randomization = 1 year)
Specific for FOSTER-CabOS randomised trial (part-2): IGF1 (Insuline-Like Growth Factor 1)
in paediatric patients < 18 years with Tanner stage 1 to 2 at inclusion To evaluate whether cabozantinib affects the longitudinal growth in Pediatric population .
Measured: at baseline in part 2, End of treatment at 12 cycles, and every year until 8 years
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.
Measured: at baseline in part 2, every 3 months during the 12 cycles of cabozantinib, and End of Treatment (1 year).
FOSTER evolving study platform (part 1): quality of life (QoL) using validated instruments, including: PedQl,
Health- related QoL in patients <18 uears will be assessed using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales
Measured: Baseline, every 3 months until 8 years
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.
Measured: from diagnosis to every 3 months during 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2035 (estimated)
- Study completionJan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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, : * Experimental group: Cabozantinib orally, 40 mg/m2/day (Max=60mg/day) x1/day, administered for 12 cycles of 28 days each maximum, * Control group: the best supportive care.
- Masking
- None (open label)
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- IPSEN PHARMA S.A.S, SFCE, Rising Tide Foundation, Fondation ARC, Dutch Cancer Society, Anticancer Fund, Belgium, Kom Op Tegen Kanker, Fundacion Cientifica de la Asociacion Española contra el Cancer, Donase foundation, FOSTER consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871864
- Sponsor's protocol ID
- 2023-505575-69-01
- Other IDs
- CSET 2025-4106, 2023
- Acronym
- FOSTER
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No