Last updated on August 2020

Phase II Study of Regorafenib as Maintenance Therapy

Brief description of study

Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy.

Detailed Study Description

Patients will be randomized 1:1 using a centralized randomization software, assuring concealment, with a minimization program controlling for the following factors:

  • Histological subgroups: leiomyosarcoma versus synovial sarcoma versus other histological subtype
  • Response to doxorubicin-based chemotherapy: partial response versus stable disease
  • Centers

The treatment will be administrated as long as it appears beneficial. Evaluations will be made every 8 weeks until 6 months and then every 3 months

Clinical Study Identifier: NCT03793361

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Strasbourg, France
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CHRU Besan on

Besançon, France
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Recruitment Status: Open

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