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A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer

NCT05567835 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-04-09

Study results available
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Summary

This is a randomized pilot study to evaluate and to compare the completion rates of Total Neoadjuvant chemotherapy with FLOT ( FLOT-TNT) and perioperative chemotherapy with FLOT ( FLOT-POP).

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Fluorouracil

2600 mg/m2 IV over 26 hours (+/-1 hour) CI with home pump Day 1,15

DRUG

Leucovorin

200 mg mg/m2 IV over 2 hours Day 1,15

DRUG

Oxaliplatin

85 mg/m2 IV over 2 hours Day 1,15

DRUG

Docetaxel

60 mg/m2 IV over 60 minutes Day 1,15

BIOLOGICAL

GSCF

Recommended on day 2 and 16 of C1 of the protocol while getting chemotherapy Day 2,16

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Tannaz Armaghany, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2025-02-20
Completion
2025-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05567835 on ClinicalTrials.gov