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Uterus LeiomyosarcomaPhase 2LMS02NCT02131480

Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma

A Phase 2 study testing Doxorubicin and Trabectedin in people with Uterus Leiomyosarcoma and Soft Tissue Leiomyosarcoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Doxorubicin and Trabectedin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteFrance
Study dates
Jun 2010to Oct 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic leiomyosarcoma (uterus or soft tissue) in inoperable relapse with no previous chemotherapy
  • At least one measurable lesion according to RECIST criteria before inclusion. At least one of the target is in a none irradiated area
  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy Cancer Campus Grand Paris

    Villejuif, Val de Marne, 94805

Other trials in France

About this study

Official title: 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

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.

Being tested
Doxorubicin, Trabectedin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxorubicinDrug

    Also called Adriamycin

    60 mg/m²

  • TrabectedinDrug

    Also called Yondelis®

    1,1 mg/m²

Study groups in NCT02131480
Study groupRoleWhat they receive
Soft tissueExperimentalNot described
Receives: Drug: Doxorubicin; Drug: Trabectedin
UterusExperimentalNot described
Receives: Drug: Doxorubicin; Drug: Trabectedin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate

    Disease control rate (objective response + stability) as defined by RECIST criteria

    Measured: Assessed every 6 weeks from inclusion up to 6 months

Secondary outcomes (2)

  1. Response rate

    Assessed using RECIST criteria

    Measured: Assessed every 6 weeks from inclusion up to 6 months

  2. Progression Free Survival

    Measured: Assessed every 6 weeks from inclusion up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2014 (estimated)
  2. Study startJun 2010
  3. Primary completionJan 2013
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02131480
Sponsor's protocol ID
2009-012430-70
Other IDs
2008/1485, 2009
Acronym
LMS02
Status last verified
Jan 2017
First submitted
5 May 2014
Last updated
26 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34325109

  • Pautier 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.

    PubMed 25795402

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxorubicin and Trabectedin in people with Uterus Leiomyosarcoma and Soft Tissue Leiomyosarcoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (time frame: Assessed every 6 weeks from inclusion up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02131480, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.

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