Actively Recruiting
Efficacy of Regorafenib Combined With Best Supportive Care as Maintenance Treatment in High Grade Bone Sarcomas Patients
Led by Centre Leon Berard · Updated on 2026-02-17
36
Participants Needed
16
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Regorafenib Combined With Best Supportive Care as Maintenance Treatment in High Grade Bone Sarcomas Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older at the time of consent
- Histologically confirmed high-grade bone sarcomas including osteosarcomas, Ewing sarcomas, chondrosarcomas, undifferentiated pleomorphic sarcomas, leiomyosarcomas, and angiosarcomas
- Evaluable residual disease not removable by surgery after standard multimodal treatment at diagnosis or chemotherapy at relapse
- Non-progressive disease at study entry as defined by RECIST 1.1
- Interval of at least 4 weeks and no more than 2 months between last anticancer treatment and start of regorafenib
- Life expectancy greater than 6 months
- ECOG performance status less than 2 (Karnofsky score 70% or higher)
- Adequate bone marrow, liver, kidney, coagulation, and pancreatic function as defined by laboratory tests
- Recovery to Grade 0 or 1 toxicity levels from prior treatments except alopecia, anemia, hypothyroidism
- Agreement to use adequate contraception during treatment and specified periods after
- Signed informed consent
- Willingness and ability to follow study visits and procedures
- Affiliation to Social Security System
- Body surface area of at least 1.30 m2 at consent
You will not qualify if you...
- Prior treatment with any VEGFR inhibitor including regorafenib, sunitinib, sorafenib, pazopanib, or bevacizumab
- All soft tissue sarcomas and chordomas
- History of other malignancies within 3 years except certain skin or cervical cancers
- Cardiovascular dysfunction including low ejection fraction, recent heart attack, unstable angina, uncontrolled hypertension, recent thrombotic events
- Major surgery or significant injury within 28 days before study drug
- Ongoing significant infection (Grade >2)
- Known HIV infection not meeting specific criteria
- Active or chronic hepatitis B or C requiring treatment
- Dehydration Grade >1
- Difficulty swallowing oral medication or gastrointestinal conditions affecting absorption
- Seizure disorder requiring medication
- Enrollment in another trial with investigational therapies
- Known hypersensitivity to regorafenib or excipients
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test
- Psychological, familial, sociological, or geographical conditions that impair compliance
- History of non-compliance with medical regimens
- Interstitial lung disease with active symptoms
- Non-healing wounds, ulcers, or bone fractures
- History or evidence of significant bleeding disorders or recent major bleeding
- Clinically significant unrelated systemic illness compromising tolerance or study procedures
- Use of prohibited concurrent medications
- Patients under legal tutorship or curatorship
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Chu Besancon
Besançon, France, 25030
Not Yet Recruiting
2
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
3
Centre Georges Francois Leclerc
Dijon, France, 21079
Not Yet Recruiting
4
Centre Oscar Lambret
Lille, France, 59020
Not Yet Recruiting
5
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
6
Hopital de La Timone
Marseille, France, 13385
Actively Recruiting
7
Icm Val D'Aurelle
Montpellier, France, 34298
Not Yet Recruiting
8
Hotel Dieu Nantes
Nantes, France, 44093
Not Yet Recruiting
9
Institut Curie
Paris, France, 75005
Actively Recruiting
10
Hôpital COCHIN
Paris, France, 75014
Actively Recruiting
11
Ico Rene Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
12
Chu Saint-Etienne
Saint-Priest-en-Jarez, France, 42270
Not Yet Recruiting
13
CHRU Hôpital Hautepierre
Strasbourg, France, 67098
Actively Recruiting
14
ICANS
Strasbourg, France, 67200
Not Yet Recruiting
15
Iuct Oncopole
Toulouse, France, 31059
Actively Recruiting
16
Institut Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
Research Team
J
Julien GAUTIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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