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

Sponsor
Ukrainian Society of Clinical Oncology
Study ID
NCT06028737
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Gastric Adenocarcinoma
  • Advanced Gastric Carcinoma
  • Advanced Gastroesophageal Junction Adenocarcinoma
  • Chemotherapy
  • Gastrectomy
  • Gastrectomy for Gastric Cancer
  • Gastric (Cardia, Body) Cancer
  • Gastric Adenocarcinoma
  • Gastric Cancer
  • Gastric Neoplasm
  • Gastric Resection
  • GastroEsophageal Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Gastrointestinal Cancer
  • Stomach Cancer
  • Stomach Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 8, 2023
Start date
Mar 25, 2025
Status verified
Apr 2025
Primary completion
Apr 25, 2027
Completion
Dec 31, 2032

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Perioperative 4+4 FLOT cycles
    4 cycles of neoadjuvant FLOT chemotherapy regimen, followed by surgery and 4 cycles of adjuvant FLOT chemotherapy regimen.
  • Experimental: Total Neoadjuvant ChemoTherapy (TNT) 8 FLOT cycles
    8 cycles of total neoadjuvant FLOT chemotherapy regimen, followed by surgery.

Primary Outcome Measure

All 8 planned FLOT cycles tolerance rate. [ Time Frame: From enrollment to the end of treatment at 12 weeks ]

Central Contacts

Find similar trials

Nationwide
Gastric cancer trialsOncology trialsGI oncology trials

Related Studies