drugset / Trial / NCT03788226
A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
FNF-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in China to prove superiority of POF over S-1/docetaxel in postoperative adjuvant setting for pStage III gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).
Timeline
- Start
- 2019-02-01
- Primary completion
- 2021-12-31
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 135 mg/m2 | — |
| Comparator | S-1 | Small molecule | 40 mg | Oral |
| Comparator | S-1 | Small molecule | 50 mg | Oral |
| Comparator | S-1 | Small molecule | 60 mg | Oral |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |