Actively Recruiting
A Multicentre Phase II Study of Regorafenib as Maintenance Treatment in Patients With High Grade Bone Sarcomas Without Complete Remission After Standard Treatment
Led by Centre Leon Berard · Updated on 2026-02-17
36
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter phase II study to assess patients with high-grade bone sarcoma who have not achieved complete remission after standard treatment at diagnosis or relapse. The study aims to evaluate whether regorafenib combined with best supportive care (BSC) can be an effective maintenance therapy to delay disease progression in these patients. Data on progression-free rate (PFR) will be collected to determine if this combination warrants further investigation for this condition. Patients who have completed standard treatments, such as multimodal therapy at diagnosis or chemotherapy at relapse, and have unresectable residual disease will receive regorafenib plus BSC as maintenance treatment. The regimen consists of 28-day cycles, with 21 days of regorafenib followed by 7 days of rest, for up to 12 months or 13 cycles. Dosage adjustments or treatment interruptions may occur if there is toxicity. After completing therapy or if disease progresses earlier, patients will be followed until the first radiological progression and for up to 12 months after the last inclusion, with vital status checked at 24 months. Participants will be monitored through scheduled visits including laboratory tests and imaging to evaluate disease status and treatment tolerance. The primary outcome is progression-free rate at 4 months following treatment start. Secondary measures include progression-free survival, overall survival, response rates, disease control rates at 2 and 4 months, quality of life, and treatment safety over up to three years. Patients must comply with treatment plans and follow-up schedules to support data collection during the study period.
CONDITIONS
Brief 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 unresectable residual disease 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 or Karnofsky score 70% or higher
- Adequate bone marrow, liver, kidney, coagulation, and pancreatic function as defined by laboratory tests
- Recovery from prior treatment toxicities to grade 0 or 1 except alopecia, anemia, and hypothyroidism
- Use of adequate contraception during treatment and for specified months after last dose
- Signed informed consent
- Willingness and ability to comply with study visits, treatment, and tests
- Affiliated with Social Security System
- Body Surface Area at least 1.30 m² at consent
You will not qualify if you...
- Prior treatment with any VEGFR inhibitor including regorafenib, sunitinib, sorafenib, pazopanib, bevacizumab
- All soft tissue sarcomas and chordomas
- Other malignancies within 3 years except certain skin or cervical cancers
- Cardiovascular dysfunction including low ejection fraction, heart failure, recent myocardial infarction, arrhythmias requiring therapy, unstable or recent angina, uncontrolled hypertension, or recent thrombotic events
- Major surgery, open biopsy, or significant trauma within 28 days before study drug
- Ongoing infection grade greater than 2
- Known HIV infection unless meeting specific controlled criteria
- Active or chronic hepatitis B or C requiring treatment
- Dehydration grade greater than 1
- Difficulty swallowing oral medication or gastrointestinal conditions affecting absorption
- Seizure disorders requiring medication
- Concurrent enrollment in another clinical trial with investigational therapies
- Known hypersensitivity to study drug or excipients
- Pregnancy, breastfeeding, or potential pregnancy without negative test
- Psychological, social, or geographical conditions interfering with compliance
- History of non-compliance or unwillingness to follow protocol
- Interstitial lung disease with symptoms
- Non-healing wounds or fractures
- History of significant bleeding events
- Serious unrelated systemic illness compromising ability to tolerate treatment
- Use of prohibited concomitant medications
- Under legal tutorship 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) for screening and enrollment
Duration - Up to 12 months
Participants receive regorafenib combined with best supportive care as maintenance treatment. Treatment cycles last 28 days, including 21 days of regorafenib followed by 7 days rest. Treatment continues until disease progression, unacceptable toxicity, willingness to stop, or up to 12 months maximum.
Treatment cycles every 28 days for up to 13 cycles
Duration - Up to 12 months post-treatment with a vital status update at 24 months after last inclusion
After completing maintenance therapy, participants are followed up until the first radiological disease progression or up to 12 months after treatment ends. Vital status will be updated once at 24 months after last inclusion.
Visits as per follow-up schedule until disease progression or data cutoff
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
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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