OncoMatch/Clinical Trials/NCT07871864
Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse
Official title: FOSTER Evolving Study Platform
Is NCT07871864 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies Experimental group : Cabometyx ® 40mg/m2/day (Max: 60mg/day) , Treatment schedule : Daily**, day 1-28 during 4 weeks (ie. 1 cycle) during 12 cycles for osteosarcoma.
Treatment: Experimental group : Cabometyx ® 40mg/m2/day (Max: 60mg/day) , Treatment schedule : Daily**, day 1-28 during 4 weeks (ie. 1 cycle) during 12 cycles — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Osteosarcoma
Disease stage
Metastatic disease required
Osteosarcoma Metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Performance status < 2 for patient adult, or >70 using Karnofsky or Lansky performance scores.
Demographics
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1 x 10^9/L; platelets ≥ 100 x 10^9/L; haemoglobin ≥ 8.0 g/dL (or corrected by growth factor or transfusion before C1D1); INR/PTT ≤1.5 x ULN
Kidney function
Serum creatinine ≤ 1.5 x ULN or based on age/gender; if serum creatinine is greater than maximum for age/gender, creatinine clearance (or GFR) must be >60 ml/min/1.73 m2; urine dipstick < 2+ for proteinuria or spot protein/creatinine ratio grade 2 (≤) per CTCAE v5.0; no clinical evidence of nephrotic syndrome
Liver function
ALT/AST ≤ 2.5 x 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 ≤2.5 x ULN (≤5 x ULN in patient with liver involvement); if alkaline phosphatase > 2.5 ULN, GGT < 1.5 x ULN; lipase ≤1.5 x ULN
Cardiac function
LVEF ≥50% and/or fractional shortening >28% at baseline by echocardiography or MUGA scan
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 10^9/L; Platelets ≥ 100 x 10^9/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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07871864 currently recruiting?
Yes, this trial is currently recruiting patients.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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