Health Trials

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

ConditionsGastric CancerStomach CancerGastroEsophageal CancerGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaAdvanced Gastric AdenocarcinomaGastric NeoplasmStomach NeoplasmGastrointestinal CancerAdvanced Gastroesophageal Junction AdenocarcinomaAdvanced Gastric CarcinomaChemotherapyGastrectomyGastrectomy for Gastric CancerGastric ResectionGastric (Cardia, Body) Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUkrainian Society of Clinical Oncology

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Docetaxel
  • Oxaliplatin
  • Leucovorin
  • Fluorouracil

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ukrainian Society of Clinical Oncology

Lead sponsor

Source ClinicalTrials.gov