In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using survival time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
834
Gemcitabine plus TS-1:Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8 followed by 2 week rest as 1 course. TS-1 was co-administered orally at 40 mg/m2 twice daily for 14 days with a rest period of 1 week as one course.
TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.
Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.
National Cancer Center Hospital
Tokyo, Japan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
No.100, Tzyou 1st Rd., Kaohsiung, Taiwan
Chang Gung Memorial Hospital, Kaohsiung
No.123, Ta-Pei Rd., Niao-Sung Hsiang, Kaohsiung Hsien, Taiwan
Over all survival(OS)
Time frame: every course for first three courses, then every other course
progression-free survival (PFS), response rate (RECIST, if measurable), incidence rate of adverse events, incidence rate of adverse drug reactions, QOL (EQ-5D)
Time frame: adverse events will be collected during treatment
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Changhua Christian Hospital
No.135, Nanxiao St., Changhua, Taiwan
National Cheng Kung University Hospital
No.138, Sheng Li Road,Tainan, Taiwan
China Medical University Hospital
No.2, Yuh-Der Rd.,Taichung, Taiwan
Taipei Veterans General Hospital
No.201, Sec. 2, Shih-Pai Road, Taipei, Taiwan
Chi Mei Medical Center Liou Ying Campus
No.201, Taikang Village, Liou Ying Township, Tainan, Taiwan
Chang Gung Memorial Hospital, Lonkou
No.5, Fu-Hsing Saint Kuei Shan Hsiang, Taoyuan Hsien, Taiwan
National Taiwan University Hospital
No.7, Chung San South Road, Taipei, Taiwan
...and 2 more locations