Randomised phase III multicentric study comparing efficacy of doxorubicin with trabectedin followed by trabectedin in non-progressive patients versus doxorubicine alone as first-line therapy in patients with metastatic or unresectable leiomyosarcoma (uterine or soft tissue) - LMS04

GUSTAVE ROUSSY0 个研究点开始时间: 2016年10月20日最近更新: 2016年10月24日

适应症

试验速览

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•1. Patients must have histologically confirmed diagnosis of metastatic or or relapsed, unresectable uterine or soft tissue leiomyosarcoma, reviewed in a reference center (among RREPS network), previously untreated with chemotherapy , and with available Formalin Fixed Paraffin Embedded (FFPE) blocks
•2. At least one measurable lesion according to RECIST V 1.1 criteria. Target could be in a previously irradiated field but has to be progressive or a biopsy had to be positive before inclusion.
•3. Age = 18 years old
•4. ECOG performance status < 2
•5. Adequate haematological, liver and cardiac functions as defined in the protocol
•6. Creatinin phosphokinase (CPK) = 2.5 x ULN
•7. Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to inclusion. Both males and WOCBP who are sexually active should be using an effective birth control method from inclusion (for WOCBP) or treatment initiation (for male) and up to 6 months following the last dose of study drug.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1. All other histological types of uterine sarcomas or soft tissue sarcomas
•2. Any contraindication for the use of trabectedin and/or doxorubicin (cardiac, renal, hepatic, known hypersensitivity…)
•3. History of another type of cancer not in complete remission for more than 3 years prior to study entry (except for cutaneous basal cell carcinoma or in situ cervical epithelioma), and/or having required any chemotherapy treatment at any time.
•4. Known cerebral metastasis
•5. History of allograft or autograft
•6. Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection

发起方

GUSTAVE ROUSSY