The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and bevacizumab are effective in the treatment of unresectable advanced gastric cancer.
In our previous phase II study of neoadjuvant docetaxel, capecitabine and cisplatin chemotherapy, patients with unresectable gastric cancer because of invasion to adjacent organs or metastasis to para-aortic lymph nodes received benefit from neoadjuvant chemotherapy. Based on these results and reports that bevacizumab enhances response rate, we planned docetaxel, capecitabine, cisplatin, and bevacizumab as neoadjuvant chemotherapy for patients with local invasion or para-aortic node metastasis alone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Bevacizumab 7.5mg/kg IV (D1) Docetaxel 60 mg/m2 IV (D1) Cisplatin 60 mg/m2 IV (D1) Xeloda 1,875 mg/m2/day/bid PO (D1-D14)
Asan Medical Center
Seoul, South Korea
R0 resection rate
R0 resection means complete resection of tumor.
Time frame: Up to 4 weeks after surgery
Overall survival
Overall survival will be measured from the start of study treatment to documented death of any cause.
Time frame: Up to 3 years
Progression-free survival
Time to progression will be measured from the start of study treatment to documented tumor progression.
Time frame: Up to 3 years
Adverse Event
Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0
Time frame: Up to 28 days after end of treatment
Angiogenetic biomarkers
cluster of differentiation 31, microvessel density, platelet derived growth factor, vascular endothelial growth factor-A, vascular endothelial growth factor receptor-1, vascular endothelial growth factor receptor-2, Neuropilin 1 and phosphatidylinositol glycan anchor biosynthesis, class F
Time frame: Baseline and 6 weeks after treatment
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