Fight Osteosarcoma Through European Research evolving study platform from diagnosis to relapse (FOSTER evolving study platform)

Osteosarcoma

For FOSTER evolving study platform: 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. The 3-year EFS rate will be estimated using Kaplan–Meier methods., For FOSTER-CabOS (first randomization) : 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.

For FOSTER evolving study platform : Feasibility and compliance: screening-to-enrolment rate, consent rate, time to enrolment/treatment start, CRF data completeness (baseline/induction), first line chemotherapy treatment delivery (dose intensity, delays, reductions, early discontinuation, reasons), adherence to scheduled follow-up visits., For FOSTER evolving study platform : Disease-free patient: A patient who remains disease-free and alive at the completion of the first line conventional chemotherapy, as determined by clinical and radiological assessments conducted between 6 and 10 months after the start of treatment., For FOSTER evolving study platform : Overall survival (OS): time from diagnosis to death from any cause, For FOSTER evolving study platform : 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., For FOSTER evolving study platform : Adverse events: incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and treatment-related mortality during induction., For FOSTER evolving study platform : Quality of life and functional outcome: QoL assessed by EORTC QLQ-C30 and PedsQL; functional outcome assessed by TESS at predefined timepoints., For FOSTER evolving study platform : Prognostic factors: association of clinical and biological variables (including G1/G2 signature at diagnosis) with OS and EFS via multivariable-adjusted Cox models. Results reported as hazard ratios (HRs) with 95% confidence intervals (CIs) (pre-specified covariates and handling of missing data per SAP)., For FOSTER-CabOS (first randomization) : 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., For FOSTER-CabOS (first randomization) : 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), For FOSTER-CabOS (first randomization) : Disease status based on initial staging and complete remission after first line treatment histological response; biological subgroups in particular G1/G2 diagnostic RNAseq signature; type of first line chemotherapy; use of mifamurtide ; age, metastatic status at diagnosis., For FOSTER-CabOS (first randomization) : Heigh and growth plate, For FOSTER-CabOS (first randomization) : Description of would healing complication, For FOSTER evolving study platform : (if applicable) Comparisons between treatment sequences: comparisons of survival overall treatment sequences using Cox proportional hazards models (with multivariable adjustment) and Kaplan–Meier estimates with log-rank tests. The absence of randomization may also imply the use of weighting methods such as Inverse Probability of Censoring Weighting ( IPCW)., For FOSTER evolving study platform : ctDNA analyses., For FOSTER evolving study platform : Radiomics analyses., For FOSTER evolving study platform : Imaging-based definition of lung metastases (number, characteristics, location) derived by AI and compared with anatomic pathology., For FOSTER evolving study platform : Incorporation of questionnaire results into clinical interpretation., For FOSTER evolving study platform : Number of countries participating in the FOSTER-Evolving study platform over time., For FOSTER evolving study platform : Number of samples collected per registered patient., For FOSTER evolving study platform : Number and type of analyses performed per registered patient., For FOSTER evolving study platform : Number and type of imaging studies centralized in the imaging repository per registered patient, For FOSTER evolving study platform : Growth plate maturation through bone age, For FOSTER-CabOS (first randomization) : Group comparison on EFS and OS (OS being defined as the time from randomisation to death from any cause. The observation will be censored at the date of last follow-up in patients alive and free of event) « Cabozantinib vs BSC » - According to G1/G2 group - According to ctDNA content at daignosis - According to composition of the TME and cancer cells in the diagnosis biopsy, For FOSTER-CabOS (first randomization) : Growth plate maturation through bone age, For FOSTER-CabOS (first randomization) : Thickness of the growth plate, For FOSTER-CabOS (first randomization) : IGF1 value

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