drugset / Trial / NCT02076594
Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer
Phase 3
Terminated
171 enrolled
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Regione Lombardia · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, parallel group, non-blinded phase III trial. Patients with advanced (locoregional or metastatic) gastric cancer not previously treated with chemotherapy for this stage will be randomized in a 1:1 ratio to receive low-TOX (arm A) or EOX (arm B). Randomization will be stratified by performance status (ECOG 0, 1 and 2).
Timeline
- Start
- 2013-01
- Primary completion
- 2018-12
- Completion
- 2018-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 625 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 750 mg/m2 | Oral |
| Subject | Docetaxel | Small molecule | 35 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |