Total neoadjuvant chemotherapy for advanced gastric and gastroesophageal cancer
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
This study is testing two different chemotherapy plans for people with advanced stomach cancer to see which one helps them better tolerate treatment and successfully have surgery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ukrainian Society of Clinical Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Vilnius and 1 other locations) |
| Trial ID | NCT06028737 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma who have not received prior oncological treatment in the last five years.
Not a fit: Patients with other active oncological diseases or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and survival rates for patients with advanced gastric and gastroesophageal cancers.
How similar studies have performed: Previous studies have shown promising results with similar chemotherapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vilnius and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.