Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse
Condition(s) studied
Investigational drug(s) / intervention(s)
Experimental group : Cabometyx ® 40mg/m2/day (Max: 60mg/day) , 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.
Study 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
Primary outcome measure(s)
- 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 . — 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. - 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 — through study completion, an average of 8 year
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.
Trial sites (77)
| Facility | City | Region | Status |
|---|---|---|---|
| Aarhus University Hospital, Department of Oncology | Aarhus | Denmark | Not Yet Recruiting |
| Aarhus University Hospital, Department of Paediatric and Adolescent Medicine | Aarhus | Denmark | Not Yet Recruiting |
| Rigshospitalet, Copenhagen University Hospital, Department of Paediatric and Adolescent Medicine | Copenhagen | Denmark | Not Yet Recruiting |
| Herlev Hospital, Department of Oncology | Herlev | Denmark | Not Yet Recruiting |
| HUS-Yhtymae, Medical treatment and Clini-cal trial units | Helsinki | Finland | Not Yet Recruiting |
| HUS-Yhtymae | Helsinki | Finland | Not Yet Recruiting |
| Pohjois-Savon hyvinvointialue | Kuopio | Finland | Not Yet Recruiting |
| Pohjois-Pohjanmaan hyvinvointialue | Oulu | Finland | Not Yet Recruiting |
| Pirkanmaan hyvinvointialue | Tampere | Finland | Not Yet Recruiting |
| Varsinais-Suomen hyvinvointialue | Turku | Finland | Not Yet Recruiting |
| CHU Amiens Picardie - Site Sud | Amiens | France | Not Yet Recruiting |
| CHU Angers | Angers | France | Not Yet Recruiting |
| CHRU Besançon - Hopital Jean Minjoz - Service d'Oncologie Médicale | Besançon | France | Not Yet Recruiting |
| CHU de Bordeaux - Groupe Hospitalier Pellegrin | Bordeaux | France | Not Yet Recruiting |
| Institut Bergonié | Bordeaux | France | Not Yet Recruiting |
| CHU Brest - Hôpital Morvan | Brest | France | Not Yet Recruiting |
| CHU Caen Normandie | Caen | France | Not Yet Recruiting |
| CHU François Mitterrand | Dijon | France | Not Yet Recruiting |
| CHU Grenoble, Hôpital Couple-enfant | Grenoble | France | Not Yet Recruiting |
| CHU de La Réunion | La Réunion | France | Not Yet Recruiting |
| Centre Oscar Lambret | Lille | France | Not Yet Recruiting |
| CHU Limoges | Limoges | France | Not Yet Recruiting |
| Centre Léon Bérard | Lyon | France | Not Yet Recruiting |
| Hopital de la Timone - Service d'Hématologie et Oncologie Pédiatrique | Marseille | France | Not Yet Recruiting |
| Hopital de la Timone - Service d'Oncologie médicale | Marseille | France | Not Yet Recruiting |
| CHU Arnaud de Villeneuve | Montpellier | France | Not Yet Recruiting |
| CHU Nantes - Hôpital Femme-Enfant-Adolescent | Nantes | France | Not Yet Recruiting |
| CHU Nice | Nice | France | Not Yet Recruiting |
| Hôpital Armand Trousseau | Paris | France | Not Yet Recruiting |
| Hôpital Cochin | Paris | France | Not Yet Recruiting |
| Institut Curie | Paris | France | Not Yet Recruiting |
| CHU Poitiers | Poitiers | France | Not Yet Recruiting |
| CHU Reims | Reims | France | Not Yet Recruiting |
| Centre Eugène Marquis | Rennes | France | Not Yet Recruiting |
| CHU Rennes Hôpital Sud | Rennes | France | Not Yet Recruiting |
| CHU Charles Nicolle | Rouen | France | Not Yet Recruiting |
| CHU Saint-Etienne - Hôpital Nord | Saint-Etienne | France | Not Yet Recruiting |
| Institut de Cancérologie de l'Ouest - Site Saint-Herblain | Saint-Herblain | France | Not Yet Recruiting |
| Centre Paul Strauss | Strasbourg | France | Not Yet Recruiting |
| Hopital de Hautepierre | Strasbourg | France | Not Yet Recruiting |
+ 37 more sites — see the full list on the official registry below.
More Gustave Roussy, Cancer Campus, Grand Paris trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07871864 on ClinicalTrials.gov ↗ ← All trials in Spain