Comparing two chemotherapy regimens for gastric cancer treatment
Perioperative Chemotherapy With FOLFIRINOX Regimen or FLOT Regimen for Resectable Gastric or Esophagogastric Junction Adenocarcinoma (Type II-III): Open-label Randomized Phase 2/3 Trial
This study is testing which of two chemotherapy combinations helps people with stomach or esophagogastric junction cancer live longer after surgery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 538 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Blokhin's Russian Cancer Research Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Moscow) |
| Trial ID | NCT04393584 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two chemotherapy combinations, FLOT and FOLFIRINOX, in patients with resectable adenocarcinoma of the stomach or esophagogastric junction. A total of 538 participants will be randomly assigned to receive either treatment before and after surgery. The primary goal is to assess median overall survival rates among the two groups. Patients will undergo restaging of their tumor status after the initial treatment cycles to determine the next steps in their care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed resectable adenocarcinoma of the stomach or esophagogastric junction.
Not a fit: Patients with distant metastases or those who have received prior chemotherapy or radiation therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates for patients with resectable gastric cancer.
How similar studies have performed: Previous studies have shown promising results with similar chemotherapy regimens, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0) 2. No previous cytostatic chemotherapy or radiation therapy 3. Age 18-70 years (female and male) 4. Eastern Cooperative Oncology Group ≤ 2 5. Surgical resectability 6. Neutrophils\> 2.000/µl 7. Platelets \> 100.000/µl 8. Normal value of Serum Creatinin 9. Albumin level \> 29 г/л 10. Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper limits of normal (ULN) 11. Total Bilirubin less than 1.5 times the ULN 12. Written informed consent. Exclusion Criteria: 1. Previous cytostatic chemotherapy or radiation therapy 2. Distant metastases or all primarily not resectable stages 3. Cancer relapse 4. Complicated gastric cancer (perforation, bleeding, sub or decompensated stenosis, dysphagia IV) 5. Diarrhea ≥ 2 according to the criteria of Common Terminology Criteria for Adverse Events (CTCAE) version 4.1; 6. Hypersensitivity against 5- Fluorouracil, Leucovorin, Oxaliplatin, Epirubicin and Docetaxel 7. Existence of contraindications against 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan or Docetaxel 8. Active coronary heart disease, Cardiomyopathy or cardiac insufficiency stage III-IV according to New York Heart Association (NYHA) 9. Severe non-surgical accompanying disease or acute infection (uncontrolled arterial hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders, other tumors and others) 10. Malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma) 11. Peripheral polyneuropathy \> Grad II 12. Liver dysfunction (AST)/ALT\>3,0xULN, ALT\>3xULN, Bilirubin\>1,5xULN) 13. Serum Creatinin \>1,0xULN 14. Chronic inflammable gastro-intestinal disease 15. Inclusion in another clinical trial 16. Pregnancy or lactation 17. Hepatitis B or C in the active stage 18. Human immunodeficiency virus(HIV) infected 19. Serious concomitant somatic and mental illnesses / deviations or territorial causes that may prevent the patient from participating in the protocol and observing the protocol schedule 20. Foreigners or persons with limited legal status
Where this trial is running
Moscow
- Aleksei Kalinin — Moscow, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Ivan Stilidi, PhD — NN Blokhin National Medical Research Center of Oncology
- Study coordinator: Aleksei Kalinin, Phd
- Email: kalininalexey1986@yandex.ru
- Phone: +79197681276
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.