Trials / Recruiting

RecruitingNCT06028737

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

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

Status: Recruiting
Phase: Phase 2 / Phase 3
Study type: Interventional
Enrollment: 150 (estimated)

Sponsor: Ukrainian Society of Clinical Oncology · Academic / Other
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

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.

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 (≥cT3 and/or ≥cN0 and M0) with no history of previous oncological treatment during the last five years, who will be included in this study after reading and signing the informed consent. After the initial diagnostic laparoscopy, patients will be randomized into two groups in a 1:1 ratio, with allocation to one of the two study groups. Patients randomized to the first (control) group will receive eight cycles of the perioperative FLOT chemotherapy scheme: 4 cycles before surgical treatment and four cycles after surgical intervention. Patients randomized to the second (study) group will receive eight cycles of FLOT total neoadjuvant chemotherapy, followed by surgery. The study's primary endpoint is the proportion of patients receiving all planned chemotherapy cycles and radical surgical treatment. Secondary endpoints are perioperative morbidity and mortality (surgical and chemotherapeutic complications); disease-free survival (DFS) and 1-, 3- and 5-years overall survival (OS); quality of life during and after the treatment; correlation between the pathohistological response and chemotherapy regimen; composition and biomarkers of gut microbiota; objective tumor response. Based on previous studies, with the current standard treatment protocol-four cycles of FLOT chemotherapy before surgery and four cycles after-only 47% of patients complete all eight cycles. In contrast, with total neoadjuvant therapy, where the entire chemotherapy regimen is administered before surgery, 71% of patients are able to complete all eight FLOT cycles. Given these findings, it was calculated that to ensure 80% study power with a two-sided 5% significance level, each study group should include 65 participants. Considering an expected dropout rate of 15%, a total of 150 patients will be recruited. Up to 40 patients will be enrolled in Vilnius, Lithuania, with the remaining participants recruited in Kyiv, Ukraine.

Conditions

Interventions

Type	Name	Description
DRUG	Docetaxel	50mg/m2, d1, i.v., every 2 weeks
DRUG	Oxaliplatin	85 mg/m², d1, i.v., every 2 weeks
DRUG	Leucovorin	200 mg/m², d1, i.v., every 2 weeks
DRUG	Fluorouracil	2600 mg/m²d1 i.v. every 2 weeks

Timeline

Start date: 2025-03-25
Primary completion: 2027-04-25
Completion: 2032-12-31
First posted: 2023-09-08
Last updated: 2025-05-06

Locations

2 sites across 2 countries: Lithuania, Ukraine

Source: ClinicalTrials.gov record NCT06028737. Inclusion in this directory is not an endorsement.