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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
60 mg/m²
1,1 mg/m²
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, France
Disease control rate
Disease control rate (objective response + stability) as defined by RECIST criteria
Time frame: Assessed every 6 weeks from inclusion up to 6 months
Response rate
Assessed using RECIST criteria
Time frame: Assessed every 6 weeks from inclusion up to 6 months
Progression Free Survival
Time frame: Assessed every 6 weeks from inclusion up to 12 weeks
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