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
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 This is a randomized, open-labeled, two-arm, multi-center, phase II clinical study. Arm 1: SLOG regimen: every 14 days as one cycle S-1 35 mg/m2/b.i.d., day 1 - 7 (maximum dose: 120 mg/day) Leucovorin 30 mg/b.i.d., day 1-7; Oxaliplatin 85 mg/m2 in 250 mL of 5% Glucose, given as 2-hour intra- venous infusion, day 1; Gemcitabine 800 mg/m2 in 250 mL of normal saline, given as fixed dose-rate (FDR, 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. Arm2: GC regimen: every 21 days as one cycle Gemcitabine 1000 mg/m2 in 100 mL of normal saline, IV drip for 30 mins on D1 and D8 Cisplatin 25 mg/m2 in 250ml of normal saline, IV drip for 2 hours on D1 and D8 Treatment will be stopped in case of progressive disease, unacceptable toxicity, patients' refusal or death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Tegafur(S-1) 35 mg/m2/b.i.d., day 1 - 7 (maximum dose: 120 mg/day)
Leucovorin 30 mg/b.i.d., day 1-7
Oxaliplatin 85 mg/m2 in 250 mL of 5% Glucose, given as 2-hour intra- venous infusion, day 1
Taiwan Cooperative Oncology Group, National Health Research Institutes
Taipei, Taiwan
6-month progression-free survival rate
Tumor response will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST)Guidelines version 1.1.
Time frame: From date of registration to the date of disease progression or date of death from any cause, whichever came first, assessed up to 26 weeks .
tumor response
Efficacy evaluations: objective tumor response according to RECIST 1.1
Time frame: From date of registration to the date of disease progression or date of death from any cause, whichever came first, assessed up to 26 weeks .
Overall survival
Overall survival: defined as the time from the date of first study treatment to the date of patient death, due to any cause, or to the last date the patient was known to be alive. The primary analysis population for the overall survival will be per-protocol population. The endpoint will also be analyzed in the intent-to-treat population. Kaplan-Meier estimates will be calculated for the overall survival.
Time frame: Overall survival will be assessed. From date of registration until the date of death, assessed up to 60 months.
Disease control rate (Objective response rate (ORR) + stable disease ≧ 12 weeks)
Efficacy evaluations: objective tumor response according to RECIST 1.1
Time frame: From date of registration to the date of disease progression or date of death from any cause, whichever came first, assessed up to 26 weeks .
Safety profile
Adverse events (AEs) will be evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4 (CTCAE v4).All required pre-treatment and interim data should be available and the physician must have made a designation as to response if a re-evaluation has been performed and the grade of toxicity if any has occurred。
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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 25 mg/m2 in 250ml of normal saline, IV drip for 2 hours on D1 and D8
Time frame: From date of registration to the date of disease progression or date of death from any cause, whichever came first, assessed up to 26 weeks .
Biomarker study
evaluated for biomarkers, including inflammatory cytokine (TGF-β, hepatocyte growth factor (HGF), interleukin (IL)-6, IL-8, IL-1, CXCL-1, Chemokine (C-X-C motif) ligand 3(CXCL-3), and stromal-derived factor (SDF)...etc). Tumor DNA will be extracted from formalin-fixed paraffin-embedded(FFPE) slides for p53, CDKN2A and AT-rich interactive domain-containing protein 1A (ARID1A) mutation which were reported to be correlated with chemotherapy resistance
Time frame: From date of registration to the date of disease progression or date of death from any cause or date of unacceptable toxicity or date of patient's refusal , whichever came first, assessed up to 26 weeks .