Osteosarcoma Clinical Trials

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FOSTER Evolving Study Platform

Status: Recruiting
Location: See all (77) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Denmark
Aarhus University Hospital, Department of Oncology
NOT_YET_RECRUITING
Aarhus
Aarhus University Hospital, Department of Paediatric and Adolescent Medicine
NOT_YET_RECRUITING
Aarhus
Rigshospitalet, Copenhagen University Hospital, Department of Paediatric and Adolescent Medicine
NOT_YET_RECRUITING
Copenhagen
Herlev Hospital, Department of Oncology
NOT_YET_RECRUITING
Herlev
Finland
HUS-Yhtymae
NOT_YET_RECRUITING
Helsinki
HUS-Yhtymae, Medical treatment and Clini-cal trial units
NOT_YET_RECRUITING
Helsinki
Pohjois-Savon hyvinvointialue
NOT_YET_RECRUITING
Kuopio
Pohjois-Pohjanmaan hyvinvointialue
NOT_YET_RECRUITING
Oulu
Pirkanmaan hyvinvointialue
NOT_YET_RECRUITING
Tampere
Varsinais-Suomen hyvinvointialue
NOT_YET_RECRUITING
Turku
France
CHU Amiens Picardie - Site Sud
NOT_YET_RECRUITING
Amiens
CHU Angers
NOT_YET_RECRUITING
Angers
CHRU Besançon - Hopital Jean Minjoz - Service d'Oncologie Médicale
NOT_YET_RECRUITING
Besançon
CHU de Bordeaux - Groupe Hospitalier Pellegrin
NOT_YET_RECRUITING
Bordeaux
Institut Bergonié
NOT_YET_RECRUITING
Bordeaux
CHU Brest - Hôpital Morvan
NOT_YET_RECRUITING
Brest
CHU Caen Normandie
NOT_YET_RECRUITING
Caen
CHU François Mitterrand
NOT_YET_RECRUITING
Dijon
CHU Grenoble, Hôpital Couple-enfant
NOT_YET_RECRUITING
Grenoble
CHU de La Réunion
NOT_YET_RECRUITING
La Réunion
Centre Oscar Lambret
NOT_YET_RECRUITING
Lille
CHU Limoges
NOT_YET_RECRUITING
Limoges
Centre Léon Bérard
NOT_YET_RECRUITING
Lyon
Hopital de la Timone - Service d'Hématologie et Oncologie Pédiatrique
NOT_YET_RECRUITING
Marseille
Hopital de la Timone - Service d'Oncologie médicale
NOT_YET_RECRUITING
Marseille
CHU Arnaud de Villeneuve
NOT_YET_RECRUITING
Montpellier
CHU Nantes - Hôpital Femme-Enfant-Adolescent
NOT_YET_RECRUITING
Nantes
CHU Nice
NOT_YET_RECRUITING
Nice
Hôpital Armand Trousseau
NOT_YET_RECRUITING
Paris
Hôpital Cochin
NOT_YET_RECRUITING
Paris
Institut Curie
NOT_YET_RECRUITING
Paris
CHU Poitiers
NOT_YET_RECRUITING
Poitiers
CHU Reims
NOT_YET_RECRUITING
Reims
Centre Eugène Marquis
NOT_YET_RECRUITING
Rennes
CHU Rennes Hôpital Sud
NOT_YET_RECRUITING
Rennes
CHU Charles Nicolle
NOT_YET_RECRUITING
Rouen
CHU Saint-Etienne - Hôpital Nord
NOT_YET_RECRUITING
Saint-etienne
Institut de Cancérologie de l'Ouest - Site Saint-Herblain
NOT_YET_RECRUITING
Saint-herblain
Centre Paul Strauss
NOT_YET_RECRUITING
Strasbourg
Hopital de Hautepierre
NOT_YET_RECRUITING
Strasbourg
CHU Toulouse - Hôpital des enfants
NOT_YET_RECRUITING
Toulouse
Oncopole Claudius Regaud-IUCT Oncopole
NOT_YET_RECRUITING
Toulouse
CHU Tours, Hôpital Bretonneau
NOT_YET_RECRUITING
Tours
CHRU Nancy, Hôpital d'enfants
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Institut de Cancérologie de Lorraine
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy
RECRUITING
Villejuif
Italy
IRCCS Istituto Ortopedico Rizzoli (Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit)
NOT_YET_RECRUITING
Bologna
IRCCS Giannina Gaslini (Oncology Unit)
NOT_YET_RECRUITING
Genova
Fondazione IRCC Istituto Nazionale dei Tumori, Milano (Pediatric Oncology Unit)
NOT_YET_RECRUITING
Milan
Azienda Ospedale - Università Padova (Pediatric Oncohematology Unit)
NOT_YET_RECRUITING
Padova
AOUP Azienda Ospedaliera Universitaria Pisana (Pediatric Onco-Hematology Unit)
NOT_YET_RECRUITING
Pisa
IRCCS Istituto Nazionale Tumori Regina Elena (Experimental Clinic for Sarcomas, Rare Tumors, and Melanoma Unit)
NOT_YET_RECRUITING
Roma
IRCCS Ospedale Pediatrico Bambino Gesù (Division of Pediatric Hematology and Oncology, Gene and Cellular Therapy)
NOT_YET_RECRUITING
Roma
Ospedale Infantile Regina Margherita - AOU Città della Salute e della Scienza (Pediatric Onco-Hematology Unit)
NOT_YET_RECRUITING
Torino
Netherlands
University Medical Center Groningen
NOT_YET_RECRUITING
Groningen
Leiden University Medical Center
NOT_YET_RECRUITING
Leiden
Radboud University Medical Center
NOT_YET_RECRUITING
Nijmegen
Princess Maxima Center for Pediatric Oncology
NOT_YET_RECRUITING
Utrecht
Poland
Instytut Matki i Dziecka
NOT_YET_RECRUITING
Warsaw
Spain
Hospital Universitario Cruces
NOT_YET_RECRUITING
Barakaldo
Vall d'Hebron Institute of Oncology (VHIO)
NOT_YET_RECRUITING
Barcelona
Hospital General Universitario Gregorio Marañón, Pediatric and adolescent onco-haematology unit
NOT_YET_RECRUITING
Madrid
Hospital Universitario del Niño Jesús
NOT_YET_RECRUITING
Madrid
Hospital Virgen de la Arrixaca
NOT_YET_RECRUITING
Murcia
Hospital Universitario de Canarias
NOT_YET_RECRUITING
Santa Cruz De Tenerife
Hospital Universitario Virgen del Rocío
NOT_YET_RECRUITING
Seville
Hospital Universitari i Politècnic La Fe
NOT_YET_RECRUITING
Valencia
Hospital Universitario Miguel Servet
NOT_YET_RECRUITING
Zaragoza
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Sahlgrenska University Hospital , pediatric
NOT_YET_RECRUITING
Gothenburg
Linköping University Hospital
NOT_YET_RECRUITING
Linköping
Skåne University Hospital
NOT_YET_RECRUITING
Lund
Skåne University Hospital , oncology for adults
NOT_YET_RECRUITING
Lund
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Norrlands University Hospital
NOT_YET_RECRUITING
Umeå
Uppsala University Hospital
NOT_YET_RECRUITING
Uppsala
Uppsala University Hospital , oncology for pediatrics
NOT_YET_RECRUITING
Uppsala
Contact Information
Primary
Nathalie GASPAR, Docteur
nathalie.gaspar@gustaveroussy.fr
+33 1 42 11 41 66
Time Frame
Start Date: 2026-10-07
Estimated Completion Date: 2036-01
Participants
Target number of participants: 530
Treatments
Experimental: Cabozantinib
Cabozantinib orally, 40 mg/m2/day (Max=60mg/day) x1/day, administered for 12 cycles of 28 days each maximum
No_intervention: Best Supportive Care
Best Supportive Care according to the country
Related Therapeutic Areas
Sponsors
Collaborators: Rising Tide Foundation, Donase foundation, Fondation ARC, IPSEN PHARMA S.A.S, Kom Op Tegen Kanker, SFCE, Anticancer Fund, Belgium, Fundacion Cientifica de la Asociacion Española contra el Cancer, FOSTER consortium, Dutch Cancer Society
Leads: Gustave Roussy, Cancer Campus, Grand Paris

This content was sourced from clinicaltrials.gov

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