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Study of Atezolizumab + FLOT vs. FLOT Alone in Patients With GC/GEJ and High Immune Responsiveness

Study acronym: DANTE
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv12 Show 4 more changesShow less
    • Enrollment target: estimated 674 to confirmed 677
    • Eligibility criteria shortened, about 9 words
    • Study description shortened, about 14 words
    • Site details revised at 2 of 2 sites
  2. Trial status: Active, Not Recruiting to Recruitingv11 Show 10 more changesShow less
    • Enrollment target: 295 to 674
    • Primary completion date: Oct 15, 2025 to May 31, 2027
    • Primary endpoint revised
    • Study completion date: Oct 15, 2025 to Dec 31, 2027
    • Eligibility criteria expanded, about 62 words
    • Secondary endpoints: 6 to 5
    • Study description shortened, about 13 words
    • Site details revised at 2 of 2 sites
    • Collaborators expanded, about 3 words
    • Study title shortened, about 1 word
  3. 2 versions Re-verified since Apr 16, 2021, no change to tracked fieldsv9-v10
  4. Primary and study completion dates: Feb 2025 to Oct 15, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 5 words
    v8
  5. Site details revised at 1 of 2 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 1 to 2
    • Eligibility criteria shortened, about 10 words
    • Study description shortened, about 1 word
    v6
  2. Study site revisedv5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2018 to Sep 14, 2018
    v3
  5. Start date: Feb 2018 to Jul 2018v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicenter, randomized, controlled, open-label study comparing perioperative atezolizumab with FLOT chemotherapy versus FLOT alone in patients with locally advanced, operable adenocarcinoma of the stomach or GEJ with high immune responsiveness.
Trial Details
NCT Number NCT03421288
Lead Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators: Roche Pharma AG
Conditions
(from sponsor)		 Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Related terms Stomach Neoplasms
Enrollment 677 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov