Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas

Randomized, non-comparative, multicentre exploratory phase II study. Two arms concerning patients with bone sarcoma after the first line therapy: in the first arm, patients will be treated with Regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be kept under surveillance (standard of care). Regardless of their study arm, all the patients will be followed up until end of the study. The comparison between these two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of R

Trial Details

NCT ID
NCT04055220
Phase
NA
Sponsor
Centre Leon Berard
Status
RECRUITING
Cancer Type
Osteosarcoma Sarcoma
Interventions
  • Treatment by Regorafenib
  • Surveillance
Locations (sample)
  • Besançon, France|47.24878,6.01815
  • Bordeaux, France|44.84124,-0.58046
  • Lille, France|50.63391,3.05512
  • Lyon, France|45.74906,4.84789
  • Marseille, France|43.29695,5.38107

Key Eligibility Criteria

  • I1. Age ≥ 12 years at the day of consenting to the study;
  • I2. Patients must have histologically confirmed diagnosis of primary bone sarcoma including but not limited to: Osteosarcomas, Ewing sarcomas, Chon…
  • I3. Prior treatment for localized or metastatic disease for bone sarcoma must have been completed, consisting of a standard multimodal treatment ba…
  • For OS, (excepted head and neck localisations), neoadjuvant and/or adjuvant chemotherapy should include methotrexate-based regimen for patients \< …

For full eligibility, visit ClinicalTrials.gov.

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