Pathological Response to Perioperative FLOT in Gastric Adenocarcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación Santa Fe de Bogota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
FLOT Chemotherapy
DrugPerioperative 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.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Perioperative FLOT Cohort1 intervention
Trial outcomes
Primary outcomes
1
Pathological Complete Response Rate
Time frame
At surgical resection, after completion of preoperative FLOT (approximately 8 to 12 weeks after FLOT initiation)Secondary outcomes
1
Tumor Regression Grade (Mandard)
Time frame
At surgical resection, after completion of preoperative FLOT (approximately 8 to 12 weeks after FLOT initiation)2
Incidence of Grade 3-4 Adverse Events
Time frame
From FLOT initiation until 30 days after the last FLOT dose, up to approximately 8 months3
Proportion of Patients With FLOT Dose Modifications
Time frame
From FLOT initiation until the last FLOT dose, up to approximately 8 months4
Completion of Planned Perioperative FLOT
Time frame
From FLOT initiation until the last FLOT dose, up to approximately 8 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: