A single-arm phase II study to evaluate the efficacy and safety of docetaxel plus S-1 (DS) as second-line treatment in patients with AGC.
For patients with advanced gastric cancer, combination chemotherapy has been shown to improve the quality of life and overall survival (OS) compared with best supportive care alone. Docetaxel is an active agent for treating patients with gastric cancer. S-1, an oral 5-FU prodrug, is active against AGC as a single agent or in combination with cisplatin in phase III trials. Therefore, a single-arm phase II study was conducted to investigate the efficacy and safety of biweekly docetaxel and S-1 (DS) combination therapy as second-line treatment in patients with previously treated advanced gastric cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Docetaxel 50mg/m2 in 60 min on day 1 and repeated every 14 days.
S-1 was administered orally at 40 mg/m2 twice daily on days 1-7 of each cycle. Patients with a body surface area of less than 1.25 m2 received 80 mg S-1 daily, those with a body surface area of 1.25 m2 or more but less than 1.5 m2 received 100 mg S-1 daily, and those with a body surface area of 1.5 m2 or more received 120 mg S-1 daily.
Rongbo Lin
Fuzhou, Fujian, China
six-month overall survival
Time frame: 6 months
Objective Response Rate (ORR)
Time frame: 6 months
Overall Survival (OS)
Time frame: 12 months
Progression-Free Survival (PFS)
Time frame: 12 months
Adverse Event(AE)
Time frame: NCI CTC 4.03
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