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Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial

Study acronym: CORTIFRENCH
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Nov 28, 2024, no change to tracked fieldsv11-v12
  2. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Apr 2027 to Feb 29, 2024 · Site details revisedv10 Show 2 more changesShow less
    • Primary completion date changed from estimate of Apr 2027 to Feb 29, 2024
    • Site details revised
  3. Re-verified, no change to tracked fieldsv9
  4. Primary completion date: Apr 2026 to Apr 2027 Completion date: Sep 2026 to Sep 2027 · Eligibility criteria shortened, about 1 wordv8 Show 2 more changesShow less
    • Completion date: Sep 2026 to Sep 2027
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. 2 versions Re-verified since Feb 21, 2022, no change to tracked fieldsv6-v7
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Apr 2024 to Apr 2026 Completion date: Sep 2024 to Sep 2026v5 Show 1 more changeShow less
    • Completion date: Sep 2024 to Sep 2026
  2. Re-verified, no change to tracked fieldsv4
  3. Eligibility criteria shortened, about 10 wordsv3 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2019 to Jul 2, 2019 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2019 to Jul 2, 2019
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Severe postoperative complications are also a risk factor of poor survival in cancer patients. Seemingly, some effective therapies currently used to improve the surgical outcome (e.g. immunonutrition, enhanced-recovery protocols) have an inflammatory effect. The modulation of perioperative inflammation therefore seems crucial to improve outcomes in patients undergoing surgery for digestive cancer. A short perioperative treatment with high doses of corticosteroids has already been tested in several randomized trials. A recent meta-analysis showed that perioperative corticosteroids decreased inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery: the decrease in the risk of postoperative complications was around 50% without adverse effects.
Trial Details
NCT Number NCT03875690
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Elective Surgery for Any Digestive Cancer
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov