Efficacy of Regorafenib Combined With Best Supportive Care as Maintenance Treatment in High Grade Bone Sarcomas Patients — REGOMAIN  

Osteosarcoma Clinical Trial

Official title: A Randomized, Placebo-controlled, Double-blinded, Phase II Study of Efficacy of Regorafenib as Maintenance Treatment in Patients With High Grade Bone Sarcomas at Diagnosis or Relapse and Without Complete Remission After Standard Treatment

Status Recruiting

Clinical Trial Summary

This is a randomized, double-blinded, 2 arms study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or first relapse.

In the first arm, patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion, whereas in the second arm, patients will be treated with placebo + BSC (standard of care).

The comparison between this two arms will allow to determine whether or not regorafenib and BSC is efficient for disease control, in terms of Progression-Free Survival improvement.

Clinical Trial Description

This is a randomized, placebo-controlled, double-blinded, prospective, comparative, multicentre phase II study.

Patients with measurable unresectable residual disease will be accrued after they completed standard of care, consisting of:

• At diagnosis: multimodal treatment with neoadjuvant chemotherapy, surgery and adjuvant chemotherapy

• At relapse: chemotherapy

Patients who meet the eligibility criteria will be randomly assigned (1:1) into one of the following treatment groups:

• Experimental arm: regorafenib + best supportive care (BSC) maintenance (12 months maximum)

• Standard arm: placebo + BSC (12 months maximum)

A randomization procedure (centralized implementation of concealed random permuted blocks) will be used to obtain a balanced distribution of the setting of the disease (stratification factor): residual disease at diagnosis or at relapse after standard multimodal treatment.

After their eligibility has been confirmed, patients will receive regorafenib or its matching placebo until disease progression, or for a maximum of 12 months, or unacceptable toxicity or willingness to stop, whichever occurs first.

In case of radiological disease progression during treatment period, patients from the standard arm (placebo) who have unresectable disease will be allow to switch to experimental arm (regorafenib). After the switch, patients will be treated with regorafenib until disease progression or unacceptable toxicity or willingness to stop which occurs first.

After the completion of the maintenance therapy (12 months) patients will be followed-up until the first radiological disease progression, unless a premature disease progression occurred. All patients will be followed-up until the data cut-off (12 months after the last randomization).

The vital status will be updated once for all patients at the end of the study, based on patient's medical file.

The end of the study will be 24 months after the last randomisation or at the end of treatment of the last patient under treatment (either blinded or open label) whichever occurs last. ;

Related Conditions & MeSH terms

• Bone Sarcoma
• Osteosarcoma
• Sarcoma

• NCT number: NCT04698785
• Study type: Interventional
• Source: Centre Leon Berard
• Contact: Julien GAUTIER
• Phone: +33(0)426556829
• Email: julien.gautier@lyon.unicancer.fr
• Status: Recruiting
• Phase: Phase 2
• Start date: July 21, 2021
• Completion date: July 21, 2026