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Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

Study acronym: GABRINOX-ART
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Secondary endpoints: 19 to 20
    • Site details revised at 1 of 9 sites
    • Eligibility criteria shortened, about 4 words
    v10
  2. Study sites: 6 to 9v9
  3. Start date: Dec 15, 2020 to Jun 16, 2021
    • Site details revised at 1 of 6 sites
    v8
  4. Primary completion date: Oct 2023 to Jan 2028
    • Study completion date: Oct 2026 to Jun 2030
    v7
  5. Eligibility criteria shortened, about 27 words
    • Secondary endpoints: 16 to 19
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 5 to 6v5
  2. Site details revised at 4 of 5 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2020 to Dec 15, 2020
    • Study sites revised (5)
    v3
  4. Eligibility criteria revised
    • Secondary endpoints: 2 to 16
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma. The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.
Trial Details
NCT Number NCT04570943
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Conditions
(from sponsor)		 Locally Advanced Pancreatic Adenocarcinoma
Related terms Neoplasms
Enrollment 103 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov