Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma
LMS02
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
2 other identifiers
interventional
110
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 5, 2014
CompletedFirst Posted
Study publicly available on registry
May 6, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJanuary 26, 2017
January 1, 2017
2.6 years
May 5, 2014
January 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Disease control rate
Disease control rate (objective response + stability) as defined by RECIST criteria
Assessed every 6 weeks from inclusion up to 6 months
Secondary Outcomes (2)
Response rate
Assessed every 6 weeks from inclusion up to 6 months
Progression Free Survival
Assessed every 6 weeks from inclusion up to 12 weeks
Study Arms (2)
Soft tissue
EXPERIMENTALUterus
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Metastatic leiomyosarcoma (uterus or soft tissue) in inoperable relapse with no previous chemotherapy
- Aged \>/= 18 years and physiological age \</= 70 years
- PS \</= 2
- Normal hematological function (Polymorphonuclear Neutrophils \>/= 1500/mm3, platelets \>/= 100 000/mm3)
- Normal kidney function (creatinine \< 1.5xN)
- Creatinine phosphokinase \</= 2.5xN
- Normal hepatic function (total bilirubin \</= 1xN; transaminase \</= 2.5xN and alkaline phosphatase \</= 1.5xN)
- Cardiac function: normal echography and/or isotopic ventriculography (FR\>30%, FEVG \> 50%)
- Patients able to procreate must use a birth control device during treatment and during 3 months after treatment for women; 5 months for men
- Signed informed consent
- Patient under affiliated to a system of care
You may not qualify if:
- Any other histological type of uterus sarcoma (carcinosarcoma...) or soft tissue
- Specific contraindication to the treatment
- Previous or evolutive mental disease
- Previous cancer
- Symptomatic or known brain metastasis
- Previous radiotherapy ont he only measurable lesion
- Previous allograft or autograft
- Known positive serology (HIV, HbC, HbS)
- Pregnant or breastfeeding women
- Impossibility to follow the treatment for geographical, social or mental reason
- Patients under legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805, France
Related Publications (2)
Pautier P, Floquet A, Chevreau C, Penel N, Guillemet C, Delcambre C, Cupissol D, Selle F, Isambert N, Piperno-Neumann S, Saada-Bouzid E, Bertucci F, Bompas E, Alexandre J, Collard O, Lebrun-Ly V, Soulier P, Toulmonde M, Le Cesne A, Lacas B, Duffaud F; French Sarcoma Group. A single-arm multicentre phase II trial of doxorubicin in combination with trabectedin in the first-line treatment for leiomyosarcoma with long-term follow-up and impact of cytoreductive surgery. ESMO Open. 2021 Aug;6(4):100209. doi: 10.1016/j.esmoop.2021.100209. Epub 2021 Jul 26.
PMID: 34325109DERIVEDPautier P, Floquet A, Chevreau C, Penel N, Guillemet C, Delcambre C, Cupissol D, Selle F, Isambert N, Piperno-Neumann S, Thyss A, Bertucci F, Bompas E, Alexandre J, Collard O, Lavau-Denes S, Soulie P, Toulmonde M, Le Cesne A, Lacas B, Duffaud F; French Sarcoma Group. Trabectedin in combination with doxorubicin for first-line treatment of advanced uterine or soft-tissue leiomyosarcoma (LMS-02): a non-randomised, multicentre, phase 2 trial. Lancet Oncol. 2015 Apr;16(4):457-64. doi: 10.1016/S1470-2045(15)70070-7. Epub 2015 Mar 18.
PMID: 25795402DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2014
First Posted
May 6, 2014
Study Start
June 1, 2010
Primary Completion
January 1, 2013
Study Completion
October 1, 2016
Last Updated
January 26, 2017
Record last verified: 2017-01