NCT02131480: 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

Completed Phase 2 Last updated 25 January 2017

What this trial tests

Phase 2 trial testing Doxorubicin in Uterus Leiomyosarcoma in 110 participants. Completed in 1 October 2016.

Timeline

1 June 2010

Primary endpoint
1 January 2013

1 October 2016

Quick facts

Lead sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	1 June 2010
Primary completion	1 January 2013
Estimated completion	1 October 2016
Sites	1 location across France

Drugs / interventions tested

• Doxorubicin (doxorubicin) — full drug profile →
• Trabectedin (TRABECTEDIN) — full drug profile →

Conditions studied

• Uterus Leiomyosarcoma — all drugs for Uterus Leiomyosarcoma →
• Soft Tissue Leiomyosarcoma — all drugs for Soft Tissue Leiomyosarcoma →

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

Adults 18 to 70, any sex, with Uterus Leiomyosarcoma or Soft Tissue Leiomyosarcoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Disease control rate
  Time frame: Assessed every 6 weeks from inclusion up to 6 months
  Disease control rate (objective response + stability) as defined by RECIST criteria

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Pautier P, Floquet A, Chevreau C, Penel N, et al · · 2015 · cited 82× · PMID 25795402 · DOI 10.1016/s1470-2045(15)70070-7
2. 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.
   Pautier P, Floquet A, Chevreau C, Penel N, et al · · 2021 · cited 21× · PMID 34325109 · DOI 10.1016/j.esmoop.2021.100209
3. The Role of Trabectedin in Soft Tissue Sarcoma.
   Nakamura T, Sudo A. · · 2022 · cited 15× · PMID 35281940 · DOI 10.3389/fphar.2022.777872
4. Radiosensitizing Effect of Trabectedin on Human Soft Tissue Sarcoma Cells.
   Loi M, Salvatore G, Aquilano M, Greto D, et al · · 2022 · cited 1× · PMID 36430780 · DOI 10.3390/ijms232214305