Actively Recruiting
Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer
Led by Ukrainian Society of Clinical Oncology · Updated on 2025-05-06
150
Participants Needed
2
Research Sites
405 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tumor stage or higher and/or lymph node involvement (cN0) with no distant metastasis (M0), excluding invasion of certain major arteries and organs
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert type 2 or 3) adenocarcinoma
- Tumor differentiation grade between G0 and G4
- Tumor located at cardio-esophageal junction (Siewert 2 or 3), cardiac stomach, body, antrum, or pyloric stomach
- Tumor extension may involve esophagus, diaphragm, liver, pancreas body and tail, anterior abdominal wall, intestines, distal splenic artery, or spleen
- Patient consents to participate in the study
You will not qualify if you...
- Presence of another cancer treated less than 5 years ago at a different site
- Medical conditions or illnesses that prevent chemotherapy administration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
National Cancer Institute
Vilnius, Lithuania, 08406
Actively Recruiting
2
National Cancer Institute
Kyiv, Ukraine, 03022
Actively Recruiting
Research Team
M
Mykyta Pepenin, MD
CONTACT
O
Oleksii Dobrzhanksiy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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