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NCT02997358 · CITED IN SOURCE DOCUMENTS

Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin Versus Doxorubicine in Patients With Leiomyosarcoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2021-12-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: 1. Patients must have histologically confirmed diagnosis of metastatic 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 (Appendix 4) 5. Adequate haematological, liver and cardiac functions: * Neutrophil counts ≥ 1500/mm3 * Platelets ≥ 100 000/mm3 * Serum creatinin \< 1.5 x Upper Limit of Normal Value (UNL) * Serum bilirubin ≤1 x ULN * ALT, AST ≤ 2.5 x ULN * Alcaline phosphatases ≤ 1.5 x ULN * Cardiac ultrasound and/or normal isotopic ventriculography : Shortening Fraction (SF) \> 30%, Left Ventricular Ejection Fraction (LVEF) \> 50% 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. 8. Signed written informed consent form 9. Patient affiliated to a social security regimen or beneficiary of the same Exclusion Criteria: 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. Patient already enrolled in another therapeutic trial involving an investigational substance, and when such a substance has been taken during the previous 4 weeks. 4. Medical history of progressive psychiatric disorder 5. 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. 6. Known cerebral metastasis 7. History of allograft or autograft 8. Active viral hepatitis B or C or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection 9. Pregnant women or nursing mothers 10. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or any condition (e.g., psychological instability, geographical location, social reason, etc.) that, in the judgment of the Investigator, may affect the patient's ability to understand and sign the informed consent or to fully comply with all study visits, treatments, procedures, and other requirements scheduled in the protocol.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    6 cycles - 1 cycle every 3 weeks (day 1 to day 21) On day 1: Doxorubicin 75 mg/m² IV
    intervention Names
    1. Drug: Doxorubicin
    label
    Doxorubicin
    type
    ACTIVE_COMPARATOR
  2. description
    1. Doxorubicin + trabectedin 6 cycles - 1 cycle every 3 weeks (day 1 to day 21) Doxorubicin 60 mg/m² IV D1, then Trabectedin 1.1 mg/m² per CIV 3 hours D1. Surgery for residual disease is possible after 6 cycles (in case of non evolutive disease) 2. In case of response or stable disease after 6 cycles 3-weeks cycle until disease progression or for a maximum of 12 months of treatment (maximum 17 cycles in maintenance therapy), whichever occurs first Trabectedin 1.1 mg/m² per CIV 3 hours
    intervention Names
    1. Drug: Doxorubicin
    2. Drug: Trabectedin
    label
    doxorubicin + trabectedin followed by maintenance trabectedin
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Doxorubicin
    2. doxorubicin + trabectedin followed by maintenance trabectedin
    description
    75 mg/m² Day 1 of each 3-weeks cycle
    name
    Doxorubicin
    type
    DRUG
  2. arm Group Labels
    1. doxorubicin + trabectedin followed by maintenance trabectedin
    description
    150 μg/m²/day s.c From day 3 to day 9
    name
    Trabectedin
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
150
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Tumour assessment will be analysed using RECIST 1.1 criteria.
    measure
    Progression free Survival
    time Frame
    Until progression or 2 years after randomization, whichever occurs first
Full study description
brief Summary
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.
Source references
references
  1. citation
    Pautier P, Italiano A, Piperno-Neumann S, Chevreau C, Penel N, Firmin N, Boudou-Rouquette P, Bertucci F, Lebrun-Ly V, Ray-Coquard I, Kalbacher E, Bompas E, Collard O, Isambert N, Guillemet C, Rios M, Le Cesne A, Balleyguier C, Archambaud B, Duffaud F; French Sarcoma Group. Doxorubicin-Trabectedin with Trabectedin Maintenance in Leiomyosarcoma. N Engl J Med. 2024 Sep 5;391(9):789-799. doi: 10.1056/NEJMoa2403394.
    pmid
    39231341
    type
    DERIVED
  2. citation
    Pautier P, Italiano A, Piperno-Neumann S, Chevreau C, Penel N, Firmin N, Boudou-Rouquette P, Bertucci F, Balleyguier C, Lebrun-Ly V, Ray-Coquard I, Kalbacher E, Bardet A, Bompas E, Collard O, Isambert N, Guillemet C, Rios M, Archambaud B, Duffaud F; French Sarcoma Group. Doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin alone as first-line therapy for metastatic or unresectable leiomyosarcoma (LMS-04): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2022 Aug;23(8):1044-1054. doi: 10.1016/S1470-2045(22)00380-1. Epub 2022 Jul 11.
    pmid
    35835135
    type
    DERIVED
  3. citation
    Hanvic B, Ray-Coquard I. Gynecological sarcomas: literature review of 2020. Curr Opin Oncol. 2021 Jul 1;33(4):345-350. doi: 10.1097/CCO.0000000000000753.
    pmid
    34009140
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        ma):</p> <div class="pdq-content-list"><ol id="_2346"><li> A randomized, open-label, phase III trial (<a href="/clinicaltrials/NCT02997358">LMS-04</a> [NCT02997358]) evaluated the combination of doxorubicin and trabectedin compared with doxorubicin alone for treatment-na&#239;ve patients with metastatic and unresectable
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      source update dates
      1. context
        Updated: February 21, 2025
        datetime
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        display
        February 21, 2025

    Preserved source evidence · Not medical advice