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Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer
Sponsor: Ukrainian Society of Clinical Oncology
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.
Official title: Total Neoadjuvant Chemotherapy With 5-fluoruracil, Leucovorin, Oxaliplatin, and Docetaxel in Locally Advanced Gastric and Gastroesophageal Junction Cancer (OCTASUR): Randomized, Multi-center, Open-label Trial, Phase 2/3
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-03-25
Completion Date
2032-12-31
Last Updated
2025-05-06
Healthy Volunteers
No
Conditions
Interventions
Docetaxel
50mg/m2, d1, i.v., every 2 weeks
Oxaliplatin
85 mg/m², d1, i.v., every 2 weeks
Leucovorin
200 mg/m², d1, i.v., every 2 weeks
Fluorouracil
2600 mg/m²d1 i.v. every 2 weeks
Locations (2)
National Cancer Institute
Vilnius, Lithuania
National Cancer Institute
Kyiv, Ukraine