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

NARecruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

March 3, 2020

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2026

Conditions
Bone SarcomaOsteosarcomaEwing SarcomaChondrosarcomaUndifferentiated Pleomorphic SarcomaLeiomyosarcomaAngiosarcoma
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;"

DRUG

Treatment by Placebo

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

Trial Locations (16)

13385

RECRUITING

APHM - Hôpital Timone, Marseille

25000

RECRUITING

Hôpital Jean Minjoz, Besançon

31059

NOT_YET_RECRUITING

IUCT-Oncopole, Toulouse

33076

RECRUITING

Institut Bergonié, Bordeaux

34298

NOT_YET_RECRUITING

ICM Val d'Aurelle, Montpellier

42055

RECRUITING

Centre Hospitalier Universitaire de Saint-Etienne (CHUSE), Saint-Etienne

44805

RECRUITING

ICO René Gauducheau, Saint-Herblain

54519

NOT_YET_RECRUITING

ICL Alexis Vautrin, Vandœuvre-lès-Nancy

59020

RECRUITING

Centre Oscar Lambret, Lille

67033

RECRUITING

Institut de Cancérologie Strasbourg Europe, Strasbourg

67098

RECRUITING

Centre Hospitalier Régional de Strasbourg Hautepierre, Strasbourg

69373

RECRUITING

Centre Léon Bérard, Lyon

75005

RECRUITING

Institut Curie, Paris

75014

RECRUITING

APHP Hôpital Cochin, Paris

86000

NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Poitiers, Poitiers

94805

RECRUITING

Institut Gustave Roussy, Villejuif

All Listed Sponsors
lead

Centre Leon Berard

OTHER