RecruitingPhase 2Phase 3NCT06028737

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

Total Neoadjuvant Chemotherapy With 5-fluoruracil, Leucovorin, Oxaliplatin, and Docetaxel in Locally Advanced Gastric and Gastroesophageal Junction Cancer (OCTASUR): Randomized, Multi-center, Open-label Trial, Phase 2/3

Sponsor

Ukrainian Society of Clinical Oncology

Enrollment

150 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Stomach Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a total neoadjuvant treatment (TNT) approach using FLOT chemotherapy (a combination of four drugs: fluorouracil, leucovorin, oxaliplatin, and docetaxel) given entirely before surgery for locally advanced stomach cancer or cancer of the gastroesophageal junction. The goal is to shrink the tumor as much as possible before the operation to improve surgical and survival outcomes. **You may be eligible if...** - You have confirmed locally advanced stomach or gastroesophageal junction cancer (adenocarcinoma) - Your cancer is staged as at least cT3 or has spread to nearby lymph nodes but not distant organs (M0) - Your general health is good enough for chemotherapy (ECOG performance status 0–1) **You may NOT be eligible if...** - You have another active cancer and it has been less than 5 years since radical treatment - You have health conditions that prevent you from safely receiving chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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