Actively Recruiting
Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas
Led by Centre Leon Berard · Updated on 2026-02-17
168
Participants Needed
16
Research Sites
343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Relapse-Free Survival improvement.
CONDITIONS
Official Title
Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older at the day of consenting to the study
- Histologically confirmed primary bone sarcoma including osteosarcomas, Ewing sarcomas, chondrosarcomas, undifferentiated pleomorphic sarcomas, leiomyosarcomas, and angiosarcomas
- Completed prior standard multimodal treatment for localized or metastatic bone sarcoma according to histological subtype
- Recovery to Grade 0 or 1 toxicity or baseline level from prior treatment except alopecia, anemia, and hypothyroidism
- Interval between last chemotherapy and randomization of at least 4 weeks and no more than 2 months
- Confirmed complete remission or no evidence of disease, with limited lung nodules allowed under specific size and number criteria
- Life expectancy greater than 12 months
- Karnofsky performance status ≥70 for patients under 18 or ECOG performance status less than 2 for adults
- Adequate bone marrow, renal, and hepatic function within 7 days before treatment
- INR/PTT ≤1.5 times upper limit of normal with close monitoring if on anticoagulants
- Agreement to use adequate contraception during treatment and specified periods after last dose
- Negative pregnancy test for women of childbearing potential before treatment
- Signed informed consent
- Willing and able to follow study visits, treatment, and procedures
- Covered by medical insurance
- Body Surface Area ≥1.30 m² at consent
You will not qualify if you...
- Prior treatment with any VEGFR inhibitor such as sunitinib, sorafenib, pazopanib, or bevacizumab
- Diagnosis of soft tissue sarcomas or chordomas
- Other malignancies within 3 years prior to randomization except certain skin and cervical cancers
- Cardiovascular dysfunction including low ejection fraction, heart failure class 2 or higher, recent myocardial infarction, arrhythmias needing therapy, or unstable angina
- Uncontrolled hypertension despite optimal treatment
- Arterial or venous thrombotic or embolic events within 6 months before study drug
- Major surgery, open biopsy, or significant trauma within 28 days before study drug
- Ongoing infection above Grade 2
- Known HIV infection with exceptions if well controlled as specified
- Active or chronic hepatitis B or C requiring treatment, with exceptions if stable
- Dehydration above Grade 1
- Difficulty swallowing oral medication or gastrointestinal diseases affecting drug absorption
- Seizure disorder requiring medication
- Concurrent enrollment in another trial with investigational therapies
- Known hypersensitivity to regorafenib or excipients
- Pregnancy, likelihood of pregnancy, or breastfeeding
- Psychological, familial, sociological, or geographical conditions preventing protocol compliance
- History of non-compliance or inability to follow protocol
- Interstitial lung disease with symptoms
- Non-healing wounds, ulcers, or bone fractures
- History or evidence of bleeding disorders or recent severe bleeding
- Significant unrelated systemic illness compromising treatment tolerance
- Use of prohibited medications during the study
- Patients under legal tutorship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Hôpital Jean Minjoz
Besançon, France, 25000
Actively Recruiting
2
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
3
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
4
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
5
APHM - Hôpital Timone
Marseille, France, 13385
Actively Recruiting
6
ICM Val d'Aurelle
Montpellier, France, 34298
Not Yet Recruiting
7
Institut Curie
Paris, France, 75005
Actively Recruiting
8
APHP Hôpital Cochin
Paris, France, 75014
Actively Recruiting
9
Centre Hospitalier Universitaire de Poitiers
Poitiers, France, 86000
Not Yet Recruiting
10
Centre Hospitalier Universitaire de Saint-Etienne (CHUSE)
Saint-Etienne, France, 42055
Actively Recruiting
11
ICO René Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
12
Centre Paul Strauss - Strasbourg
Strasbourg, France, 67033
Actively Recruiting
13
Centre Hospitalier Régional de Strasbourg Hautepierre
Strasbourg, France, 67098
Actively Recruiting
14
IUCT-Oncopole
Toulouse, France, 31059
Not Yet Recruiting
15
ICL Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54519
Not Yet Recruiting
16
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
J
Julien GAUTIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here