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Randomised Phase III Multicentric Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin in Non-progressive Patients Versus Doxorubicine Alone as First-line Therapy in Patients With Metastatic or Unresectable Leiomyosarcoma (Uterine or Soft Tissue)

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Trial Profile

Randomised Phase III Multicentric Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin in Non-progressive Patients Versus Doxorubicine Alone as First-line Therapy in Patients With Metastatic or Unresectable Leiomyosarcoma (Uterine or Soft Tissue)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2023

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At a glance

  • Drugs Doxorubicin (Primary) ; Trabectedin (Primary)
  • Indications Leiomyosarcoma; Soft tissue sarcoma; Uterine cancer
  • Focus Therapeutic Use
  • Acronyms LMS04
  • Most Recent Events

    • 24 Oct 2023 Updated PFS results and final results of overall survival (OS) analyses (planned when all patients had at least 3 years of follow-up in patients with metastatic or unresectable leiomyosarcoma, presented at the 48th European Society for Medical Oncology Congress.
    • 11 Jul 2022 Primary endpoint has been met (Primary Outcome Measures:Progression free Survival), as per Results published in the Lancet Oncology
    • 11 Jul 2022 Results published in the Lancet Oncology
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