Total neoadjuvant chemotherapy for advanced gastric and gastroesophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of two different chemotherapy regimens for patients with locally advanced gastric and gastroesophageal junction adenocarcinoma. Participants will be randomized into two groups: one receiving eight cycles of total neoadjuvant chemotherapy followed by surgery, and the other receiving a combination of preoperative and postoperative chemotherapy. The primary goal is to determine the proportion of patients who can tolerate all planned chemotherapy cycles and undergo radical surgical treatment. Secondary outcomes include assessing surgical complications, disease-free survival, overall survival, quality of life, and the relationship between treatment response and gut microbiota.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Cancer Institute
  Vilnius, Lithuania Recruiting
• National Cancer Institute
  Kyiv, Ukraine Recruiting

Study contacts

• Principal investigator: Mykyta Pepenin, MD — National Cancer Institute (NCI)
• Study coordinator: Mykyta Pepenin, MD
• Email: pepenin95@gmail.com
• Phone: +380959448858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.