Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer
Recruiting now · Phase 2/Phase 3
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT06028737
- Run by
- Ukrainian Society of Clinical Oncology
- People needed
- 150
- Starts
- 2025-03-25
- Expected to finish
- 2032-12-31
- Last updated by the study team
- 2025-05-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Tumor spread according to TNM: ≥cT3 and/or ≥cN0 and M0 (except of invasion of the common hepatic artery, celiac trunk, proximal part of the splenic artery, aorta, head of the pancreas);
- Performance status by Eastern Cooperative Oncology Group (ECOG): 0 - 1;
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert type 2/3) adenocarcinoma.
- Differentiation grade: G0 - G4;
- Tumor localization: cardio-esophageal junction (Siewert 2, 3), cardiac part of the stomach, body of the stomach, antral part of the stomach, pyloric part of the stomach;
- Tumor extension: esophagus, diaphragm, liver, body and tail of the pancreas, anterior abdominal wall, small and large intestine, distal part of the splenic artery, spleen;
- Patient agrees to participate in this biomedical study.
You may not qualify if…
- Presence of another oncological disease at a different site if less than 5 years have passed since radical treatment.
- Comorbidities or patient conditions that preclude the administration of chemotherapy.
Where it is running
- National Cancer Institute — Vilnius, Lithuania (enrolling)
- National Cancer Institute — Kyiv, Ukraine (enrolling)
Full record on ClinicalTrials.gov
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