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NOT YET RECRUITING
NCT07859254

Pathological Response to Perioperative FLOT in Gastric Adenocarcinoma

Sponsor: Fundación Santa Fe de Bogota

View on ClinicalTrials.gov

Summary

Perioperative chemotherapy with the FLOT regimen (5-fluorouracil, leucovorin, oxaliplatin and docetaxel) is a standard treatment for resectable gastric and gastroesophageal junction adenocarcinoma. However, real-world studies have reported lower pathological complete response rates than the pivotal trials, and Colombian evidence is limited, coming mainly from surgical series focused on operative outcomes. This descriptive retrospective study will review the medical records of adults with stage I to III gastric or gastroesophageal junction adenocarcinoma who started perioperative FLOT at Fundación Santa Fe de Bogotá (Bogotá, Colombia) between January 1, 2021 and December 31, 2025 (approximately 90 patients). It will describe pathological response (tumor regression grade by the Mandard system and pathological complete response), grade 3-4 toxicity, dose modifications, treatment adherence and completion, recurrence and overall survival. The investigators will not assign or modify any treatment, and no hypothesis testing will be performed.

Official title: Evaluation of Pathological Response to the FLOT Regimen in the Perioperative Management of Gastric Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

90

Start Date

2026-10-01

Completion Date

2027-10-01

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DRUG

FLOT Chemotherapy

Perioperative chemotherapy with 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT), planned as four preoperative and four postoperative cycles or modified according to routine clinical practice, combined with gastrectomy. The study does not assign or modify treatment; exposure data are abstracted retrospectively from medical records.

Locations (1)

Hospital Universitario Fundación Santa Fe de Bogotá

Bogotá, Bogota D.C., Colombia