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Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.

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

Record History

  1. Primary and study completion dates: May 31, 2026 to Nov 30, 2026v10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Jan 15, 2026 to May 31, 2026
    • Site details revised at 4 of 4 sites
    v9
  3. Study sites: 3 to 4v8
  4. Re-verified, no change to tracked fieldsv7
  5. Study sites: 2 to 3v6
Show 4 earlier versionsHide 4 earlier versions
  1. Site details revised at 1 of 2 sitesv5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v4
  3. Site contacts updated at 1 of 2 sitesv3
  4. Site contacts updated at 1 of 2 sitesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In this clinical trial, patients with gastric and gastroesophageal junction adenocarcinoma will be included. Treatment with curative intent will be given with chemotherapy for 4 cycles with fluorouracil, oxaliplatin and irinotecan preoperatively followed by surgery, and then additionally 4 cycles of the same chemotherapy postoperatively. The standard treatment today is preoperative treatment with fluorouracil and oxaliplatin pre-and postoperatively. The rationale for this trial is, that the addition of irinotecan might improve treatments results.
Trial Details
NCT Number NCT03773367
Lead Sponsor Lund University Hospital
Conditions
(from sponsor)		 Resectable Gastric and Gastroesophageal Junction Adenocarcinoma
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov