This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.
Primary endpoint: Overall Response Rate Secondary endpoint: Time to progression, overall survival, safety data
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Docetaxel 50mg/m2 iv drip, repeat every two weeks; Efficacy will be evaluated every three cycles.
Fluorouracil 400mg/m2 iv D1; Fluorouracil 2400mg/m2 civ 46 hours; repeat fortnightly and evaluate every two cycles
Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Overall response rate according to RECIST 1.1
Time frame: One Year
Time to progression
Time frame: One year
Overall survival
Time frame: One year
Incidence of grade 3 or 4 toxicity
The criteria to grade the toxicity is NCI CTC 3.0
Time frame: One year
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