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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)

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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