Patients with high grade bone sarcomas (HGBS) at diagnosis or first relapse and without complete remission after standard treatment
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 high-grade bone sarcomas 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. Measurable residual disease after multimodal treatment principles either at diagnosis (after surgery and pre and/or post-surgery chemotherapy) or at first relapse (chemotherapy). I4. Non progressive disease (defined by the investigator according to the RECIST version 1.1 Appendix 1) at study entry ; I5. Interval between the date of last anticancer treatment (chemotherapy or surgery) and the date of randomization : at least 4 weeks but no longer than 2 months ; ...See the protocol Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: E1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to regorafenib, sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR inhibitor) ; E2. All soft tissue sarcomas (including but not limited to soft tissue osteosarcoma), and Ewing sarcoma, chondrosarcoma and chordoma ; E3. Prior history of 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 defined by: • Left ventricular ejection fraction (LVEF) 150mmHg or diastolic pressure > 90 mmHg despite optimal treatment) ; • 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 ; E5. Major surgical procedure, open biopsy or significant traumatic injury within 28 days before the first study drug administration ; ...See the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to compare the efficacy of regorafenib versus placebo as maintenance treatment in patients who did not achieve a complete response after their standard treatment sequence (either at diagnosis or at first relapse);Secondary Objective: To determine in both arms: • The Objective Response Rate (ORR), • The Disease Control Rate (DCR), • The Time to Treatment Failure (TTF), • The Overall Survival • The Quality of Life (EORTC QLQ-C30), • The tolerance profile (NCI-CTC AE version 5) In patients from the placebo arm who switched into the active treatment group, the following additional objectives will be studied from regorafenib initiation: • The Progression-Free Survival (PFS) • The Objective Response Rate (ORR) • The Disease Control Rate (DCR) • The Overall Survival • The tolerance profile ;Primary end point(s): The primary endpoint will be the Progression-Free Survival (PFS), defined as the time from the date of randomization to the date of first documented disease progression (according to the RECIST V1.1) or the date of death due to any cause.;Timepoint(s) of evaluation of this end point: Assessment according to the RECISTv1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Objective Response Rate (ORR) The Disease Control Rate (DCR) The Time to Treatment Failure (TTF) The Overall Survival (OS)/OS from switch The patient’s Quality of Life (EORTC QLQ-C30), The safety (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