NCT07859254Not yet recruiting
Pathological Response to Perioperative FLOT in Gastric Adenocarcinoma
Evaluation of Pathological Response to the FLOT Regimen in the Perioperative Management of Gastric Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Fundación Santa Fe de Bogota
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07859254
What you commit to
- Study type: Observational
- Planned participants: 90
- From 1 Oct 2026 to the primary completion date, 1 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lack of the minimum information required for classification (no record of the FLOT regimen received, of clinical or pathological stage, or of at least one assessment of the primary outcome).
Other illness
- Metastatic (stage IV) disease documented at initial diagnosis, before starting perioperative FLOT.
Other
- Gastric or gastroesophageal junction tumors of non-adenocarcinoma histology (for example, lymphoma, gastrointestinal stromal tumor or neuroendocrine carcinoma).
- Oncology follow-up performed exclusively outside the institution, without adequate traceability of postoperative and long-term outcomes.
Who the study is looking for
- Patients older than 18 years with histologically confirmed stage I, II or III adenocarcinoma of the stomach or gastroesophageal junction.
- Initiation of perioperative FLOT chemotherapy at Fundación Santa Fe de Bogotá between January 1, 2021 and December 31, 2025.
- Sufficient clinical and treatment information to classify the patient and evaluate at least one study outcome (pathological response, toxicity, treatment adherence and completion, recurrence or vital status).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Fundación Santa Fe de Bogotá Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.