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. 2017 Aug 29;2017(8):CD004064. doi: 10.1002/14651858.CD004064.pub4

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