Metastatic Biliary Cancer
Conditions
Keywords
biliary cancer, systemic chemotherapy, S-1, gemcitabine, cisplatin
Brief summary
To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.
Interventions
S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks
Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pathologically proven biliary adenocarinoma 2. Age \> 18 3. Evaluable disease 4. ECOG performance status of 2 or better 5. No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed 6. Adequate bone marrow function A. WBCs \> 4,000/µL, absolute neutrophil count \[ANC\]\>1,500/µL B. Hemoglobin \>9.0 g/dL C. Platelets \> 100,000/µL 7. Adequate kidney function (creatinine\<1.5 mg/dL) 8. Adequate liver function (bilirubin\<1.5 mg/dL \[\< 2.5 mg/dL for obstructive jaundice with adequately decompressed bile duct obstruction\], transaminases levels\<3 times the upper normal limit, and serum albumin of \>2.5 mg/dL) 9. No serious medical or psychological condition that would preclude study treatment 10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion criteria
1. Other tumor type than adenocarcinoma 2. Evidence of GI bleeding or GI obstruction 3. Presence or history of CNS metastasis 4. Pregnancy or breastfeeding 5. Other serious illness or medical conditions 6. Axial skeletal radiotherapy within 6 months 7. Neuropathy grade 2 or worse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival rate at 6 months | 6 months | progression-free survival wad defined as the time from the date of enrollment to the date of the first occurrence of objective disease progression or death from any cause, which occur first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | up to 36 months | Overall survival is calculated from the date of enrollment to the date of death from any cause. |
| Response rate | 6 months | Response to chemotherapy will be assessed using RECIST 1.0 criteria. |
| Toxicities | Up to 24 months | Toxicities associated chemotherapy will be assessed and categorized using NCI CTCAE v3.0. The types of toxicities and the proportions of patients who experience each toxicity will be described. |
Countries
South Korea
Outcome results
None listed