Trial Evaluating the Tolerance and Safety of Durvalumab - RT Combination for Treatment in SCCHN

Study acronym: REWRITe
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Jul 2026 to Mar 9, 2026
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description expanded, about 9 words
  2. 3 versions Re-verified since Jun 23, 2023, no change to tracked fieldsv9-v11
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 73 to confirmed 61
    • Site details revised at 2 of 2 sites
    v8
  4. Primary completion date: Feb 2024 to Jul 2026
    • Study completion date: Dec 2024 to Aug 2026
    • Eligibility criteria expanded, about 20 words
    v7
  5. Primary completion date: Sep 2021 to Feb 2024
    • Study completion date: Dec 2021 to Dec 2024
    • Eligibility criteria shortened, about 78 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria expanded, about 122 wordsv5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 2019 to Jul 17, 2019
    v4
  3. Start date: Feb 2019 to Sep 2019v3
  4. Start date: Dec 2018 to Feb 2019
    • Study description expanded, about 12 words
    v2
  1. Study First Submitted
  • 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.
This study evaluate the regional (neck) nodal control of durvalumab in combination with RT restricted to the primary tumor and the immediately adjacent nodal level (i.e. without prophylactic neck irradiation) in N0 patients with SCCHN.
Trial Details
NCT Number NCT03726775
Lead Sponsor Groupe Oncologie Radiotherapie Tete et Cou
Collaborators: UNICANCER, Center Eugene Marquis
Conditions
(from sponsor)		 HNSCC
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov