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Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas

NCT04055220 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-02-17

No results posted yet for this study

Summary

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

Interventions

DRUG

Treatment by Regorafenib

Treatment for 13 cycles (12 months) maximum. During each cycle, patient will take once a day, during 21 days, followed by 7 days without treatment : * 3 tablets daily, corresponding to a total of 120 mg of Regorafenib (3 weeks out of 4 weeks) in patients ≥ 16 years old and patients \< 16 years old with BSA ≥ 1.70m²; * 2 tablets daily corresponding to a total of 80 mg of Regorafenib (3 weeks out of 4 weeks) in patients \< 16 years old with 1.30m² ≤ BSA \< 1.70m²;

OTHER

Surveillance

Followed up patients in the exact same way as patients in the experimental arm

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Jean-Yves BLAY · Centre Léon Bérard, Lyon

  • Florence DUFFAUD · Hôpital de la Timone (MARSEILLE)

  • Sophie PIPERNO-NEUMANN · Institut Curie Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04055220 on ClinicalTrials.gov