Status:
RECRUITING
Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer
Lead Sponsor:
Ukrainian Society of Clinical Oncology
Conditions:
Gastric Cancer
Stomach Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 ca...
Detailed Description
This is a multi-center international European prospective randomized study that aims to enroll participants with resectable locally advanced gastric and gastroesophageal (Siewert 2, 3) adenocarcinoma ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06028737
Start Date
March 25 2025
End Date
December 31 2032
Last Update
May 6 2025
Active Locations (2)
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1
National Cancer Institute
Vilnius, Lithuania, 08406
2
National Cancer Institute
Kyiv, Ukraine, 03022