NCT06028737 Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer
| NCT ID | NCT06028737 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Ukrainian Society of Clinical Oncology |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2027-04-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2025-03-25 with a primary completion date of 2027-04-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Mykyta Pepenin, MD
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT06028737 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06028737 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06028737 currently recruiting?
Yes, NCT06028737 is actively recruiting participants. Contact the research team at pepenin95@gmail.com for enrollment information.
Where is the NCT06028737 trial being conducted?
This trial is being conducted at Vilnius, Lithuania, Kyiv, Ukraine.
Who is sponsoring the NCT06028737 clinical trial?
NCT06028737 is sponsored by Ukrainian Society of Clinical Oncology. The principal investigator is Mykyta Pepenin, MD at National Cancer Institute (NCI). The trial plans to enroll 150 participants.
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