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Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy

Study acronym: RT-Immune
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment target: estimated 69 to confirmed 62v12
  2. Primary completion date: Aug 7, 2023 to Dec 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Aug 1, 2024 to Dec 30, 2026
    • Site details revised at 6 of 6 sites
    v11
  3. Primary completion date: Aug 1, 2022 to Aug 7, 2023
    • Study sites: 5 to 6
    • Study completion date: Aug 1, 2023 to Aug 1, 2024
    • Eligibility criteria expanded, about 13 words
    v10
  4. Primary completion date: Jul 31, 2022 to Aug 1, 2022
    • Study completion date: Jul 30, 2023 to Aug 1, 2023
    v9
  5. Trial status: Active, Not Recruiting to Recruitingv8 Show 4 more changesShow less
    • Enrollment target: 22 to 69
    • Primary completion date: Jul 31, 2021 to Jul 31, 2022
    • Study completion date: Jul 31, 2022 to Jul 30, 2023
    • Site details revised at 5 of 5 sites
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Jul 31, 2020 to Jul 31, 2021
    • Study completion date: Jul 31, 2021 to Jul 31, 2022
    v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 69 to confirmed 22
    • Study sites: 4 to 5
    v6
  3. Study sites: 3 to 4
    • Eligibility criteria revised
    • Study description expanded, about 15 words
    v5
  4. Primary completion date: Jul 2020 to Jul 31, 2020
    • Study completion date: Apr 2021 to Jul 31, 2021
    • Start date changed from estimate of Aug 2018 to Aug 1, 2018
    • Site details revised at 2 of 3 sites
    v4
  5. Start date: Apr 2018 to Aug 2018v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Centre Leon Berard
70 trials monitored
See 2 trials at risk
Sarcoma
1,026 trials monitored
See 67 trials at risk
This multicentric, randomised, Phase II trial will use a pick-the-winner design in order to evaluate the clinical and biological activity of atezolizumab when combined with pre-operative or post-operative radiotherapy in STS patients. Following Inform Consent Form (ICF) signature, eligible patients will be randomised (1:1:1) to receive: * Arm A: Radiotherapy followed by atezolizumab then surgery. * Arm B: Atezolizumab followed by surgery then radiotherapy. * Arm C: Radiotherapy then surgery followed by atezolizumab. The sequence of the study treatments is different among the 3 study arms. However, the dose regimens will be the same: * Atezolizumab will be administered to all patients at the dose of 1200mg, by IV injection, for 2 cycles (Q3W). * Radiotherapy will be administered to all patients at the dose of 2Gy/day, 5 days per week, for a total of 5 weeks and 50Gy. * Surgery will be performed as per institutional practice. Randomisation will be stratified according to histological subtypes as follows: Group 1: Liposarcoma (LPS), Undifferentiated Pleomorphic Sarcoma (UPS), Leiomyosarcoma (LMS), myxofibrosarcoma, angiosarcoma versus Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma (RMS) and myxoid LPS.
Trial Details
NCT Number NCT03474094
Lead Sponsor Centre Leon Berard
Collaborators: Roche Pharma AG
Conditions
(from sponsor)		 Sarcoma,Soft Tissue
Related terms Sarcoma
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov