Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer
Sponsor: National Health Research Institutes, Taiwan
Summary
To evaluate the following items in patients with locally advanced and metastatic biliary tract cancer receiving SLOG or GC treatment, Primary objective: 6-month progression-free survival rate Secondary objectives: Objective response rate Disease control rate (Objective response rate (ORR) + stable disease ≧ 12 weeks) Progression-free Survival Overall survival Safety profile Biomarker study
Official title: Phase II Randomized Trial of S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) vs Gemcitabine and Cisplatin (GC) in Locally Advanced or Metastatic Biliary Tract Cancer
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2018-04-19
Completion Date
2024-12-31
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Tegafur
Tegafur(S-1) 35 mg/m2/b.i.d., day 1 - 7 (maximum dose: 120 mg/day)
Leucovorin
Leucovorin 30 mg/b.i.d., day 1-7
Oxaliplatin
Oxaliplatin 85 mg/m2 in 250 mL of 5% Glucose, given as 2-hour intra- venous infusion, day 1
Gemcitabine
Gemcitabine 800 mg/m2 in 250 mL of normal saline, given as fixed dose-rate (, 10 mg/m2/min) infusion, day 1; After the administration of gemcitabine, the infusion line should be flushed with 20 ml of normal saline and then 50 ml of 5% glucose solution before the administration of oxaliplatin. in SLOG arm. Gemcitabine 1000 mg/m2 in 100 mL of normal saline, IV drip for 30 mins on D1 and D8 ,in GC arm
Cisplatin
Cisplatin 25 mg/m2 in 250ml of normal saline, IV drip for 2 hours on D1 and D8
Locations (1)
Taiwan Cooperative Oncology Group, National Health Research Institutes
Taipei, Taiwan