MedTrace Logo

Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer

NCT06028737 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-05-06

No results posted yet for this study

Summary

The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery:

1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, and Docetaxel (FLOT) followed by surgery.
2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.

Conditions

  • Gastric Cancer
  • Stomach Cancer
  • GastroEsophageal Cancer
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Advanced Gastric Adenocarcinoma
  • Gastric Neoplasm
  • Stomach Neoplasm
  • Gastrointestinal Cancer
  • Advanced Gastroesophageal Junction Adenocarcinoma
  • Advanced Gastric Carcinoma
  • Chemotherapy
  • Gastrectomy
  • Gastrectomy for Gastric Cancer
  • Gastric Resection
  • Gastric (Cardia, Body) Cancer

Interventions

DRUG

Docetaxel

50mg/m2, d1, i.v., every 2 weeks

DRUG

Oxaliplatin

85 mg/m², d1, i.v., every 2 weeks

DRUG

Leucovorin

200 mg/m², d1, i.v., every 2 weeks

DRUG

Fluorouracil

2600 mg/m²d1 i.v. every 2 weeks

Sponsors & Collaborators

  • Ukrainian Society of Clinical Oncology

    lead OTHER

Principal Investigators

  • Mykyta Pepenin, MD · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2027-04-25
Completion
2032-12-31

Countries

  • Lithuania
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06028737 on ClinicalTrials.gov