Pathological Response to Perioperative FLOT in Gastric Adenocarcinoma

September 29, 2026 updated by: Henry Alexander Vargas Diaz, Fundación Santa Fe de Bogota

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Gastric cancer is the fifth most frequent cancer and the fourth leading cause of cancer death worldwide. In resectable disease, perioperative FLOT (four preoperative and four postoperative cycles) improved pathological regression and overall survival compared with epirubicin-based regimens in the FLOT4-AIO trial. Real-world series such as RealFLOT reported a lower pathological complete response rate (7.3%) than the pivotal trial, and a Colombian series reported 8.4%. There is no systematic institutional characterization of tolerance, pathological response, adherence and completion of perioperative FLOT in Colombia.

Design: Single-center, observational, descriptive, retrospective cohort (case series) study. All patients received the same regimen and there is no comparator group; the study has no hypothesis-testing purpose.

Population and identification: Adults older than 18 years with histologically confirmed stage I, II or III gastric or gastroesophageal junction adenocarcinoma who started perioperative FLOT at Fundación Santa Fe de Bogotá between January 1, 2021 and December 31, 2025. Patients will be identified through institutional oncology, chemotherapy pharmacy and surgical pathology databases, and all eligible patients will be included (census sampling; approximately 90 patients). Data collection will start only after notification of the study to INVIMA (Colombian regulatory agency) as a phase IV observational study.

Data collection and outcome ascertainment: Data will be recorded in an institutional REDCap database with pseudonymized study codes and validation rules. Outcomes will be identified through a systematic multi-source search (surgical pathology reports, oncology records, chemotherapy pharmacy records, imaging reports, emergency, inpatient and consultation notes). Key events (pathological response, toxicity, progression and recurrence) will be independently adjudicated by two investigators, with disagreements resolved by consensus, and a random 10% sample of records will be double-checked for data-entry quality. Follow-up runs from FLOT initiation (index date) until recurrence, death, end of follow-up or loss to follow-up.

Outcomes: The primary outcome is pathological response in the institutional surgical specimen, reported as the Mandard tumor regression grade (TRG) and the pathological complete response rate. Secondary outcomes include grade 3-4 adverse events according to CTCAE version 5.0, dose modifications (reduction, delay or discontinuation) and their reasons, adherence and completion of the planned perioperative regimen, cumulative incidence of recurrence and overall survival.

Statistical analysis: The analysis will be exclusively descriptive, without significance testing or causal inference, using available cases with explicit denominators and no imputation. Categorical variables will be summarized as frequencies and proportions with Wilson 95% confidence intervals, and continuous variables as means and standard deviations or medians and interquartile ranges. Results will be stratified by prespecified categories (stage, Lauren subtype, TRG). Overall survival will be estimated with the Kaplan-Meier method from FLOT initiation, with probabilities at 12, 24 and 36 months. Recurrence will be described from the date of R0 resection with the cumulative incidence function (Aalen-Johansen estimator), treating death without recurrence as a competing event. Analyses will be performed in R.

Ethics: The study is classified as research without risk under Colombian Resolution 8430 of 1993, with a waiver of informed consent for retrospective record review. The protocol (version 3.0, July 29, 2026) was approved by the Comité Corporativo de Ética en Investigación of Fundación Santa Fe de Bogotá (CCEI-20373-2026). Data will be handled in accordance with the Declaration of Helsinki (2024 revision) and Colombian Law 1581 of 2012.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia
        • Hospital Universitario Fundación Santa Fe de Bogotá

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults older than 18 years with histologically confirmed stage I, II or III gastric or gastroesophageal junction adenocarcinoma who started perioperative FLOT chemotherapy at Hospital Universitario Fundación Santa Fe de Bogotá (Bogotá, Colombia) between January 1, 2021 and December 31, 2025, identified through institutional oncology, chemotherapy pharmacy and surgical pathology databases.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Metastatic (stage IV) disease documented at initial diagnosis, before starting perioperative FLOT.
  • Gastric or gastroesophageal junction tumors of non-adenocarcinoma histology (for example, lymphoma, gastrointestinal stromal tumor or neuroendocrine carcinoma).
  • 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).
  • Oncology follow-up performed exclusively outside the institution, without adequate traceability of postoperative and long-term outcomes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: RETROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Perioperative FLOT Cohort
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.

Other Names:
  • Leucovorin
  • 5-Fluorouracil
  • Oxaliplatin
  • FLOT
  • Docetaxel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pathological Complete Response Rate
Time Frame: At surgical resection, after completion of preoperative FLOT (approximately 8 to 12 weeks after FLOT initiation)
At surgical resection, after completion of preoperative FLOT (approximately 8 to 12 weeks after FLOT initiation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Tumor Regression Grade (Mandard)
Time Frame: At surgical resection, after completion of preoperative FLOT (approximately 8 to 12 weeks after FLOT initiation)
At surgical resection, after completion of preoperative FLOT (approximately 8 to 12 weeks after FLOT initiation)
Incidence of Grade 3-4 Adverse Events
Time Frame: From FLOT initiation until 30 days after the last FLOT dose, up to approximately 8 months
From FLOT initiation until 30 days after the last FLOT dose, up to approximately 8 months
Proportion of Patients With FLOT Dose Modifications
Time Frame: From FLOT initiation until the last FLOT dose, up to approximately 8 months
From FLOT initiation until the last FLOT dose, up to approximately 8 months
Completion of Planned Perioperative FLOT
Time Frame: From FLOT initiation until the last FLOT dose, up to approximately 8 months
From FLOT initiation until the last FLOT dose, up to approximately 8 months
Cumulative Incidence of Recurrence
Time Frame: From R0 resection until recurrence, death or last follow-up, assessed at 12, 24 and 36 months (up to approximately 6 years)
From R0 resection until recurrence, death or last follow-up, assessed at 12, 24 and 36 months (up to approximately 6 years)
Overall Survival
Time Frame: From FLOT initiation until death or last follow-up, assessed at 12, 24 and 36 months (up to approximately 6 years)
From FLOT initiation until death or last follow-up, assessed at 12, 24 and 36 months (up to approximately 6 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Santa Fe de Bogota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Henry Alexander Vargas Díaz, MD, Fundación Santa Fe de Bogotá

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCEI-20373-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. Data are obtained from a retrospective review of medical records under a waiver of informed consent and are protected under Colombian personal data protection law (Law 1581 of 2012). Aggregated results will be published in a peer-reviewed journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings