drugset / Trial / NCT05264896
Perioperative FLOT vs Adjuvant XELOX for CA Stomach
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a single centre randomised controlled trial, comparing perioperative FLOT versus adjuvant XELOX for locally advanced gastric and esophagogastric junction cancers. Patients with operable clinical T3 or above and N1 or above gastric and esophagastric junction cancer would be recruited. Participants would be randomised to perioperative FLOT versus adjuvant XELOX with curative radical gastrectomy. Primary outcome would be 3 year Disease Free Survival. It was calculated that 110 patients would be required to demonstrate the study hypothesis.
Timeline
- Start
- 2022-03-21
- Primary completion
- 2024-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 50 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2600 mg/m2 | — |