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Evaluation of the Efficacy and the Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer (FOLFIRINOX 3)

Study acronym: FOLFIRINOX3
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 30 to 32 Primary completion date changed from estimate of Nov 21, 2024 to Jan 16, 2023 · Completion date: Nov 21, 2024 to Jul 16, 2025v4 Show 2 more changesShow less
    • Primary completion date changed from estimate of Nov 21, 2024 to Jan 16, 2023
    • Completion date: Nov 21, 2024 to Jul 16, 2025
  2. Primary and study completion dates: Jan 7, 2023 to Nov 21, 2024 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 55 to confirmed 30 · Site details revisedv3 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 55 to confirmed 30
    • Site details revised
  3. Primary completion date: Nov 7, 2018 to Jan 7, 2023 Completion date: Dec 11, 2022 to Jan 7, 2023 · Start date: Oct 11, 2018 to Nov 7, 2018v2 Show 2 more changesShow less
    • Completion date: Dec 11, 2022 to Jan 7, 2023
    • Start date: Oct 11, 2018 to Nov 7, 2018
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In patients in progression after oxaliplatin and irinotecan, the study FOLFIRINOX 3 proposes to evaluate the interest of modifying the standard pattern of administration of the molecule of irinotecan in order to make it more efficient. In combination with other chemotherapy drugs (5-fluorouracil, oxaliplatin, folinic acid and bevacizumab), irinotecan will be administered at the beginning and end of each cycle of chemotherapy, whereas it is normally administered at one time in the regimen. standard of treatment. The hypothesis of this study is an increase in the objective response rate at 2 months of 10 to 30% with a scheme by FOLFIRINOX3 - bevacizumab compared to an optimal treatment to date by FOLFIRINOX-bevacizumab.
Trial Details
NCT Number NCT03795311
Lead Sponsor Centre Georges Francois Leclerc
Conditions Colorectal Cancer
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov