Clinical Trial

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

Study acronym: INTENSE
Active, Not Recruiting Phase 2
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Summary
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2018-12-10; most recent amendment 2025-09-03.
Status change: Recruiting → Active, Not Recruiting 2024-02-01
Status change: Not Yet Recruiting → Recruiting 2019-01-18
Trial Details
NCT Number NCT03773367
Lead Sponsor Lund University Hospital
Conditions Resectable Gastric and Gastroesophageal Junction Adenocarcinoma
Enrollment 60 participants
Start Date 2018-12-14
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-10