Soft Tissue Leiomyosarcoma Clinical Trial
Official title:
A Multicentric Phase II Trial Studying Efficacy of Doxorubicin Associated With Trabectedin (Yondelis) in First Line Treatment on Patients With Metastatic Leiomyosarcoma (Uterus or Soft Tissue) and/or Inoperable Relapse
Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when
metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin,
ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in
first line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of
soft tissue.
The trabectedin is a new cancer drug that has obtained marketing authorization after failure
of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe.
It has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.
This study aims to evaluate the usefulness of the combination of trabectedin with
doxorubicin in first-line treatment of uterine or soft tissue leiomyosarcoma.
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