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Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

Study acronym: ISG-ARTICLE
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026v11
  2. Study completion date: Dec 31, 2025 to Dec 31, 2026v10
  3. Primary completion date: Jun 30, 2024 to Dec 31, 2025
    • Study completion date: Sep 1, 2024 to Dec 31, 2025
    v9
  4. Study sites: 16 to 17v8
  5. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 13 to 16
    • Primary completion date: Sep 1, 2024 to Jun 30, 2024
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Oct 15, 2021 to Oct 29, 2021
    • Site contacts updated at 13 of 13 sites
    v6
  2. Start date: Jun 15, 2021 to Oct 15, 2021v5 Show 4 more changesShow less
    • Interventions: Gemcitabine (Drug), Trabectedin (Drug) to Gemcitabine (Drug), No Intervention: Observational Cohort (Drug), Trabectedin (Drug)
    • Study description expanded, about 99 words
    • Site contacts updated at 2 of 13 sites
    • Study arms: 2 to 3
  3. Start date: May 1, 2021 to Jun 15, 2021
    • Primary endpoint revised
    • Secondary endpoints: 5 to 6
    v4
  4. Start date: Jan 15, 2021 to May 1, 2021v3
  5. Start date: Sep 1, 2020 to Jan 15, 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Italian Sarcoma Group
11 trials monitored
See 1 trial at risk
Ovarian Cancer
1,336 trials monitored
See 90 trials at risk
Sarcoma
1,026 trials monitored
See 67 trials at risk
Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator. In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option. In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype.
Trial Details
NCT Number NCT04383119
Lead Sponsor Italian Sarcoma Group
Collaborators: PharmaMar
Conditions
(from sponsor)		 Leiomyosarcoma of Ovary, Soft Tissue Sarcoma
Related terms Sarcoma
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov