drugset / Trial / NCT04393584
FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients with resectable adenocarcinoma of the stomach or the esophagogastric junction (II-III type by Siewert) without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX). Main objective of the study is median overall survival.
Timeline
- Start
- 2019-01-29
- Primary completion
- 2024-01-01
- Completion
- 2026-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | 50 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2450 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2600 mg/m2 | — |