Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer
OCTASUR
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
1 other identifier
interventional
150
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Mar 2025
Longer than P75 for phase_2 gastric-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2032
May 6, 2025
April 1, 2025
2.1 years
August 26, 2023
April 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All 8 planned FLOT cycles tolerance rate.
The proportion of patients receiving all planned cycles of chemotherapy and radical surgical treatment.
From enrollment to the end of treatment at 12 weeks
Secondary Outcomes (10)
Chemotherapy toxicity rate and profile.
At the end of each FLOT cycle (each cycle is 14 days), up to 14 days after the last cycle.
Surgical complications rate.
30 days after surgery.
Median overall survival.
From the start of treatment to the patient's death or the end of follow-up - 5 years follow-up after the last intervention.
Progression-free survival.
Calculated as the time from the start of treatment to disease progression or the end of follow-up at 5 years after the treatment completion.
Quality of patients' life.
24 months.
- +5 more secondary outcomes
Study Arms (2)
Perioperative 4+4 FLOT cycles
ACTIVE COMPARATOR4 cycles of neoadjuvant FLOT chemotherapy regimen, followed by surgery and 4 cycles of adjuvant FLOT chemotherapy regimen.
Total Neoadjuvant ChemoTherapy (TNT) 8 FLOT cycles
EXPERIMENTAL8 cycles of total neoadjuvant FLOT chemotherapy regimen, followed by surgery.
Interventions
50mg/m2, d1, i.v., every 2 weeks
85 mg/m², d1, i.v., every 2 weeks
200 mg/m², d1, i.v., every 2 weeks
2600 mg/m²d1 i.v. every 2 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Cancer Institute
Vilnius, 08406, Lithuania
National Cancer Institute
Kyiv, 03022, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mykyta Pepenin, MD
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 26, 2023
First Posted
September 8, 2023
Study Start
March 25, 2025
Primary Completion (Estimated)
April 25, 2027
Study Completion (Estimated)
December 31, 2032
Last Updated
May 6, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be available after initial paper is published.
After the initial publication every participant will receive all the data to provide further data exploration.