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A Multicentre Phase II Study of Efficacy of Regorafenib as Maintenance Treatment in Patients With High Grade Bone Sarcomas at Diagnosis or Relapse and Without Complete Remission After Standard Treatment
This is a multicenter phase II study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or at relapse. Patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion. Progression free rate (PFR) data will be collected and analysed for all included patients to evaluate if regorafenib + BSC can be considered as an interesting treatment for further investigations in this indication.
This is a multicenter phase II study. Patients with evaluable unresectable residual disease will be accrued after they completed standard of care, consisting of: * At diagnosis: standard multimodal treatment based on histological subtype * At relapse: chemotherapy Patients who meet the eligibility criteria will receive regorafenib + best supportive care (BSC) as maintenance treatment for a maximum 12 months period. After their eligibility has been confirmed, patients will receive regorafenib until disease progression, or for a maximum of 12 months, or unacceptable toxicity or willingness to stop, whichever occurs first. After the completion of the maintenance therapy (12 months) patients will be followed-up until the first radiological disease progression, unless a premature disease progression occurred. All patients will be followed-up until the data cut-off (12 months after the last inclusion). The vital status will be updated once for all patients at 24 months after the last inclusion, based on patient's medical file.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
Chu Besancon
Besançon, France
Institut Bergonie
Bordeaux, France
Centre Georges Francois Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Leon Berard
Lyon, France
Hopital de La Timone
Marseille, France
Icm Val D'Aurelle
Montpellier, France
Hotel Dieu Nantes
Nantes, France
Institut Curie
Paris, France
Hôpital COCHIN
Paris, France
Start Date
July 21, 2021
Primary Completion Date
July 21, 2026
Completion Date
July 21, 2026
Last Updated
February 17, 2026
36
ESTIMATED participants
Treatment by regorafenib and best supportive care
DRUG
Lead Sponsor
Centre Leon Berard
NCT07479732
NCT06541262
Data Source & Attribution
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