NCT02855788.
Trial name or title | Phase II study of weekly metronomic chemotherapy using weekly aclitaxel, Oxaliplatin, Leucovorin and 5‐FU (POLF) in participants with advanced gastric cancer |
Methods | Phase 2 Intervention Model: Single‐group assignment Masking: Open‐label Primary Purpose: Treatment |
Participants | N = 40 18‐70 years AJCC stage 3 or 4 gastric cancer |
Interventions | Experimental: POLF regimen Paclitaxel 60 mg/m² , oxaliplatin 50 mg/m² , leucovorin 20 mg/m² , and 5‐FU 425 mg/m² IV weekly Intervention: Drug: paclitaxel 60 mg/m² , oxaliplatin 50 mg/m² , leucovorin 20 mg/m² , and 5‐FU 425 mg/m² IV weekly |
Outcomes | Response rate [Time frame: 3 months] ‐based on Recist 1.1 Adverse events [Time frame: 2 years] ‐based on NCI‐CTC v.2 Progression‐free survival [Time frame: 2 years] Overall survival [Time frame: 2 years] |
Starting date | May 2015 |
Contact information | Contact: Nick N Chen, M.D., Ph.D. 206‐588‐1722 nicknchenmd@gmail.com Contact: Jie Liu, M.D. 021‐5288236 jieliu@fudan.edu.cn |
Notes |