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Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients

Study acronym: TRASTS
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary endpoints: 1 to 2v9 Show 5 more changesShow less
    • Enrollment target: 165 to 199
    • Study sites: 16 to 17
    • Eligibility criteria expanded, about 81 words
    • Secondary endpoints revised (10)
    • Study description expanded, about 18 words
  2. Primary completion date: Jun 2021 to Jun 2028
    • Study completion date: Dec 2021 to Jun 2028
    • Site contacts updated at 2 of 16 sites
    v8
  3. Primary completion date: Jun 2020 to Jun 2021
    • Study completion date: Dec 2020 to Dec 2021
    • Eligibility criteria revised
    v7
  4. Enrollment target: 96 to 165v6 Show 7 more changesShow less
    • Primary completion date: Dec 2017 to Jun 2020
    • Study sites: 17 to 16
    • Study completion date: Jun 2018 to Dec 2020
    • Eligibility criteria expanded, about 709 words
    • Secondary endpoints: 5 to 10
    • Study description expanded, about 128 words
    • Study title shortened, about 6 words
  5. Primary completion date: Feb 2016 to Dec 2017
    • Study completion date: Mar 2017 to Jun 2018
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 19 to 17v4
  2. Primary completion date: Dec 2015 to Feb 2016v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 19 of 19 sites
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in four cohorts of patients: Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma. Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Cohort C: Patients with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma). Cohort D (Phase II only): Patients with well differentiated liposarcoma and G2 dedifferentiated liposarcoma (with less than 30% dedifferentiated component). Phase I: escalating dose of 1.3 or 1.5 mg/m2. Phase I for cohort C: de-escalating dose of 1.5 or 1.3mg/m2 Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction). Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort C: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort D: 45Gy in 25 fractions (1.8Gy/fraction). A translational substudy is developed to analyse different biomarkers predictive value. Cohorts A and B are closed to recruitment in 2023.
Trial Details
NCT Number NCT02275286
Lead Sponsor Grupo Espanol de Investigacion en Sarcomas
Collaborators: Centre Leon Berard, Italian Sarcoma Group
Conditions
(from sponsor)		 Liposarcoma, Myxoid, Sarcoma, Soft Tissue, Leiomyosarcoma, Liposarcoma, Pleomorphic Liposarcoma
Related terms Leiomyosarcoma, Liposarcoma, Liposarcoma, Myxoid, Sarcoma
Enrollment 199 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov