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

Launched by UKRAINIAN SOCIETY OF CLINICAL ONCOLOGY · Aug 31, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the best way to treat patients with locally advanced gastric cancer, which is a type of stomach cancer that has not yet spread to distant parts of the body. The trial will compare two different approaches to chemotherapy before and after surgery. One group of participants will receive a total of 8 cycles of chemotherapy (known as Total Neoadjuvant Chemotherapy or TNT) before their surgery, while the other group will receive 4 cycles of chemotherapy before surgery and then another 4 cycles after surgery. Researchers want to see how well these treatments work in reducing the cancer.

To be eligible for this trial, participants should be between the ages of 18 and 80, have a specific type of stomach cancer called adenocarcinoma, and have not had previous cancer treatments. Patients should also be in reasonably good health, meaning they can carry out daily activities with little to no assistance. If someone decides to participate, they can expect to undergo chemotherapy followed by surgery, and they will be closely monitored throughout the process. This trial is currently recruiting participants, and it aims to find better treatment options for this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.