Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin Versus Doxorubicine in Patients With Leiomyosarcoma (LMS04)
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|ClinicalTrials.gov Identifier: NCT02997358|
Recruitment Status : Not yet recruiting
First Posted : December 20, 2016
Last Update Posted : January 9, 2017
The objective of LMS04 study is to better define the treatment strategy for patients with metastatic leiomyosarcoma (uterine or soft tissue), as well as identifying the best first line therapeutic option for these patients. LMS04 will test a new strategy for first line therapy LMS sarcoma compare to the reference therapy (6 cycles of doxorubicin alone): the interest of the association of trabectedin to doxorubicin in first line treatment followed by trabectedin alone for non-progressive patients after 6 cycles of the association of trabectedin and doxorubicin (the LMS02 design).
LMS04 will be the first phase III randomized study specifically dedicated to soft tissue leiomyosarcoma in first line metastatic disease.
It is planned to compare a new doxorubicin combination (including trabectedin) with very encouraging results followed by trabectedin maintenance therapy for non-progressive patients to doxorubicin alone. Prospective ancillary translational studies will attempt to define profiles of patients who could benefit from this new chemotherapy in an exploratory way.
The validation of a new first line option specific for LMS, identifying clinical factors that characterize aggressiveness and responsiveness to treatment aims to have an important in the spirit of personalized medicine in this rare and deadly disease.
|Condition or disease||Intervention/treatment||Phase|
|Uterine or Soft Tissue Leiomyosarcoma||Drug: Doxorubicin Drug: Trabectedin||Phase 3|
|Study Type :||Interventional|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Doxorubicin
6 cycles - 1 cycle every 3 weeks (day 1 to day 21) On day 1: Doxorubicin 75 mg/m² IV
Experimental: doxorubicin + trabectedin followed by maintenance trabectedin
- Progression free Survival [ Time Frame: Until progression or 2 years after randomization, whichever occurs first ]Tumour assessment will be analysed using RECIST 1.1 criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997358
|Contact: Patricia PAUTIER, MD||0142114517 ext +firstname.lastname@example.org|
|Contact: Benjamin LACAS||0142116039 ext +email@example.com|
|Villejuif, Val de Marne, France, 94805|