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

Recruiting now · Not applicable

Conditions studied: Bone Sarcoma, Osteosarcoma, Ewing Sarcoma, Chondrosarcoma, Undifferentiated Pleomorphic Sarcoma, Leiomyosarcoma, Angiosarcoma

In brief

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 facts

Study ID

NCT04055220

Run by

Centre Leon Berard

People needed

168

Starts

2020-03-03

Expected to finish

2026-10-01

Last updated by the study team

2026-02-17

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• I1. Age ≥ 12 years at the day of consenting to the study;
• I2. Patients must have histologically confirmed diagnosis of primary bone sarcoma including but not limited to: Osteosarcomas, Ewing sarcomas, Chondrosarcomas, Undifferentiated Pleomorphic Sarcomas (UPS), Leiomyosarcomas (LMS) and Angiosarcomas;
• I3. Prior treatment for localized or metastatic disease for bone sarcoma must have been completed, consisting of a standard multimodal treatment based on the histological subtype:
• For OS, (excepted head and neck localisations), neoadjuvant and/or adjuvant chemotherapy should include methotrexate-based regimen for patients < 18 years old; patients ≥ 18 years old may have received either methotrexate-based regimen or anthracycline and cisplatin-based regimen For head and neck OS, neoadjuvant and/or adjuvant chemotherapy should include adriamycin, cisplatin or ifosfamide-based regimen.
• For non-OS, neoadjuvant and/or adjuvant chemotherapy should include adriamycin and/or cisplatin-based regimen.
• I4. Recovery to NCI-CTCAE v5 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug/procedure related toxicity (except alopecia, anaemia, and hypothyroidism);
• I5. Interval between the last chemotherapy administration and the date of randomisation: at least 4 weeks but no longer than 2 months;
• I6. Confirmed complete remission or no evidence of disease (for metastatic disease);
• Patients with pulmonary micro nodules can be included provided they do not meet the following criteria:
• At least one lung nodule of 10mm or more
• And/or at least two nodules well limited between 6-9mm
• And/or at least 5 nodules well limited of 5mm or less All the other situations will be considered as doubtful lesions except in case of metastatic disease confirmed during the lung surgery of the residual lung lesions after pre-operative chemotherapy. If no other metastatic localisation is detected at the initial staging, the patient will be considered as localised disease and eligible for randomisation.
• I7. Life expectancy of greater than 12 months;
• I8. Karnofsky Performance status ≥70 (patients younger than 18-year old) or ECOG performance status < 2 (adult patients) ;
• I9. Patients must have adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:
• Absolute neutrophil count ≥ 1.5 Giga/l
• Platelets ≥ 100 Giga/l
• Haemoglobin≥ 9 g/dl
• Serum creatinine ≤ 1.5 x ULN
• Glomerular filtration rate (GFR) ≥30 ml/min/1.73m2 according to the Modified Diet in Renal Disease (MDRD) abbreviated formula
• AST and ALT ≤2.5 x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer)
• Bilirubin ≤1.5 X ULN
• Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in patient with liver involvement of their cancer). If Alkaline phosphatase > 2.5 ULN, hepatic isoenzymes 5-nucleotidase or GGT tests must be performed; hepatic isoenzymes 5-nucleotidase must be within the normal range and/or GGT < 1.5 x ULN.
• Lipase ≤1.5 x ULN
• Spot urine must not show ≥ 1 "+"protein in urine or the patient will require a repeat urine analysis. If repeat urinalysis shows 1 "+" protein or more, a 24-hour urine collection will be required and must show total protein excretion <1000 mg/24 hours

Where it is running

• Hôpital Jean Minjoz — Besançon, France (enrolling)
• Institut Bergonié — Bordeaux, France (enrolling)
• Centre Oscar Lambret — Lille, France (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)
• APHM - Hôpital Timone — Marseille, France (enrolling)
• ICO René Gauducheau — Saint-Herblain, France (enrolling)
• Centre Paul Strauss - Strasbourg — Strasbourg, France (enrolling)
• Centre Hospitalier Régional de Strasbourg Hautepierre — Strasbourg, France (enrolling)
• Institut Gustave Roussy — Villejuif, France (enrolling)
• Institut Curie — Paris, France (enrolling)
• APHP Hôpital Cochin — Paris, France (enrolling)
• Centre Hospitalier Universitaire de Saint-Etienne (CHUSE) — Saint-Etienne, France (enrolling)
• ICM Val d'Aurelle — Montpellier, France
• IUCT-Oncopole — Toulouse, France
• ICL Alexis Vautrin — Vandœuvre-lès-Nancy, France
• Centre Hospitalier Universitaire de Poitiers — Poitiers, France

Full record on ClinicalTrials.gov

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