drugset / Trial / NCT05567835
A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized pilot study to evaluate and to compare the completion rates of Total Neoadjuvant chemotherapy with FLOT ( FLOT-TNT) and perioperative chemotherapy with FLOT ( FLOT-POP).
Timeline
- Start
- 2024-03-06
- Primary completion
- 2025-02-20
- Completion
- 2025-02-20
Outcome
Outcome not reported
Stopped (Enrollment): “Since activation, 3 subjects were enrolled but were ineligible for randomization to a treatment arm because of a positive diagnostic laparoscopy result. Given the repeat inability to enroll and randomize an eligible subject; accrual was halted.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2600 mg/m2 | Intravenous |
| Background | GSCF | Unknown | — | — |