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

RecruitingPhase 2, Phase 3Ages 18 Years - 80 YearsAllUkrainian Society of Clinical Oncology
NCT06028737 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Docetaxel
  • Oxaliplatin
  • Leucovorin
  • Fluorouracil
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Where

2 sites
National Cancer Institute
Vilnius, Lithuania
National Cancer Institute
Kyiv, Ukraine
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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