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

Sponsor
Centre Leon Berard
Study ID
NCT04055220
Status
Recruiting
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Conditions

  • Angiosarcoma
  • Bone Sarcoma
  • Chondrosarcoma
  • Ewing Sarcoma
  • Leiomyosarcoma
  • Osteosarcoma
  • Undifferentiated Pleomorphic Sarcoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Treatment by Regorafenib — DRUG
    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;
  • Surveillance — OTHER
    Followed up patients in the exact same way as patients in the experimental arm

Study Details

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.

Key Dates

First listed
Aug 13, 2019
Start date
Mar 3, 2020
Status verified
Feb 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regorafenib
    Treatment will be divided in 28 days cycles, including a 21-day period of treatment by regorafenib followed by a 7-day period of rest. In case of toxicity, dose can be reduced or treatment interrupted according to Specific Product Characteristics (SPC). Patients can receive up to a maximum of 13 cycles (maximum treatment period : 12 Months).
  • Other: Surveillance
    No intervention is performed for patients in this arm; however, they receive the identical surveillance as patients of the experimental arm.

Primary Outcome Measure

Relapse-Free Survival (RFS) [ Time Frame: Up to 5 years ]

Central Contacts

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