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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether regorafenib can help control bone sarcoma after initial treatment. Bone sarcomas are rare cancers of the bone with several types, including osteosarcomas, Ewing sarcomas, and chondrosarcomas. Despite advances, survival rates have plateaued, making new treatment options essential. This phase II study explores if adding regorafenib as maintenance therapy after first-line treatment can delay return or progression of the disease compared to standard surveillance. Participants are randomly assigned to one of two groups. One group receives regorafenib in 28-day cycles: 21 days of treatment followed by 7 days off, for up to 12 months. Dosage varies based on age and body surface area. The other group undergoes standard surveillance without additional treatment but with the same follow-up schedule. Close monitoring will evaluate disease control and safety in both groups. During the study, participants will have regular visits for assessments including relapse-free survival over up to 5 years, treatment failure, overall survival, quality of life, safety, and treatment adherence. Clinical tests will check blood counts, organ function, and possible side effects. Patients will be monitored closely to track health status and disease recurrence throughout the study duration.
CONDITIONS
Brief 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 consent
- Histologically confirmed primary bone sarcoma including osteosarcoma, Ewing sarcoma, chondrosarcoma, undifferentiated pleomorphic sarcoma, leiomyosarcoma, or angiosarcoma
- Completed standard multimodal treatment (chemotherapy and/or surgery) appropriate to sarcoma subtype
- Recovery to grade 0 or 1 toxicity level from prior treatment (except alopecia, anemia, hypothyroidism)
- Interval of 4 weeks to 2 months since last chemotherapy before randomization
- Confirmed complete remission or no evidence of active disease
- Life expectancy greater than 12 months
- Karnofsky Performance status ≥70 (under 18 years) or ECOG <2 (adults)
- Adequate bone marrow, kidney, and liver function within 7 days before treatment start
- INR/PTT ≤1.5 times normal or stable if on blood thinners
- Use of adequate contraception during and after treatment as specified
- Negative pregnancy test for women of childbearing potential
- Signed informed consent
- Willing and able to comply with study 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 (e.g., sunitinib, sorafenib, pazopanib, bevacizumab)
- Soft tissue sarcomas or chordomas
- Other cancers within 3 years except certain skin or cervical cancers
- Significant heart conditions including low ejection fraction, recent heart attack, or unstable angina
- Uncontrolled high blood pressure
- Recent blood clots or embolic events within 6 months
- Major surgery or injury within 28 days before treatment
- Ongoing infections above grade 2
- Known HIV infection not controlled as specified
- Active or untreated hepatitis B or C
- Dehydration grade above 1
- Difficulty swallowing oral medications or gastrointestinal conditions affecting absorption
- Seizure disorder requiring medication
- Concurrent participation in another investigational trial
- Allergic reactions to study drug components
- Pregnant or breastfeeding women
- Psychological or social conditions affecting study compliance
- History of non-compliance with medical regimens
- Interstitial lung disease with symptoms
- Non-healing wounds or fractures
- History of significant bleeding disorders or recent severe bleeding
- Serious unrelated systemic illnesses
- Use of prohibited medications
- Under legal guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive treatment by taking regorafenib orally in cycles of 21 days on treatment followed by 7 days off treatment, for up to 13 cycles (maximum 12 months). Dose adjustments may occur based on tolerance.
Monthly visits during treatment cycles
Duration - Up to 5 years
Participants are monitored for relapse, survival, quality of life, and safety outcomes after completing treatment or surveillance.
Regular follow-up visits over 5 years
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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