Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin Versus Doxorubicine in Patients With Leiomyosarcoma
NCT ID: NCT02997358
Last Updated: 2021-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2017-01-18
2021-07-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Doxorubicin
6 cycles - 1 cycle every 3 weeks (day 1 to day 21) On day 1: Doxorubicin 75 mg/m² IV
Doxorubicin
75 mg/m² Day 1 of each 3-weeks cycle
doxorubicin + trabectedin followed by maintenance trabectedin
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
Doxorubicin
75 mg/m² Day 1 of each 3-weeks cycle
Trabectedin
150 μg/m²/day s.c From day 3 to day 9
Interventions
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Doxorubicin
75 mg/m² Day 1 of each 3-weeks cycle
Trabectedin
150 μg/m²/day s.c From day 3 to day 9
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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Gustave Roussy
Villejuif, Val De Marne, France
Countries
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References
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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.
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.
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.
Other Identifiers
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2016/2410
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002186-56
Identifier Type: -
Identifier Source: org_study_id