Patients with bone sarcomas other than Ewing sarcoma or chondrosarcoma or chordoma, who have no residual disease after neoadjuvant chemotherapy, surgery and/or adjuvant chemotherapy.
Conditions
Sponsors
Centre Léon Bérard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1. Age = 16 years at the day of consenting to the study; I2. Patients must have histologically confirmed diagnosis of primary bone sarcoma of one of the following histotypes: • Osteosarcomas (conventional-intramedullary/central high grade, small cell, telangiectatic or high-grade surface osteosarcomas); • Bone sarcomas other than Ewing sarcoma, chondrosarcoma and chordoma. I3. Availability of archival Formalin-Fixed Paraffin Embedded (FFPE) block. I4. Prior treatment for localized or metastatic disease for bone sarcoma must have been completed. It should include: • Neoadjuvant chemotherapy with documented assessment of histological response, • Local procedure: Surgery (or radiotherapy if tumour is unresectable) • Adjuvant chemotherapy (Nota Bene: patients with histotype different from osteosarcoma may not have received adjuvant treatment). For OS, (excepted head and neck localisations), neoadjuvant and/or adjuvant chemotherapy should include methotrexate-based regimen for patients =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: E1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR inhibitor); E2. All soft tissue sarcomas (including but not limited to soft tissue osteosarcoma and Ewing soft tissue sarcoma), and Ewing sarcoma, chondrosarcoma and chordoma; E3. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within 3 years prior to randomization; E4. Cardiovascular dysfunction: • Left ventricular ejection fraction (LVEF) 150mmHg or diastolic pressure > 90 mmHg despite optimal treatment); E6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the last 6 months before the first study drug administration; ...See the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the antitumor efficacy of regorafenib versus placebo as maintenance treatment in patients with bone sarcomas. ;Secondary Objective: • The Time to Treatment Failure (TTF), • The Overall Survival, • The Quality of Life (EORTC QLQ-C30), • The tolerance profile (NCI-CTC AE version 5), • Compliance to study treatment ;Primary end point(s): the Relapse-Free Survival (RFS).;Timepoint(s) of evaluation of this end point: assessment according to the RECISTv1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • the Time to Treatment Failure (TTF), • the Overall Survival, • the Quality of Life (EORTC QLQ-C30), • the tolerance profile (NCI-CTC AE version 5). ;Timepoint(s) of evaluation of this end point: • Throughout the study • Each tumor assessment | — |
Countries
France
Contacts
Public ContactDRCI
Centre Léon Bérard
Outcome results
None listed