Biliary Tract Cancer
Conditions
Brief summary
To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.
Detailed description
Gemcitabine/cisplatin combination therapy (GC) has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (BTC). Investigators have evaluated the efficacy and safety of gemcitabine/cisplatin/S-1 combination therapy (GCS) for patients with advanced BTC and observed the promising efficacy. In this randomized phase Ⅲ study, investigators aimed to compare GCS with GC in patients with advanced BTC.
Interventions
Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
DRUGGemcitabine/Cisplatin /S-1
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
Sponsors
Kansai Hepatobiliary Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with cytologically or histologically proved biliary tract cancer 2. age \>=20 years 3. Performance Status (PS) 0-2 4. No prior history of chemotherapy or radiotherapy. 5. Adequate bone marrow function (neutrophil count \>=1,500/mm3, and platelet count \>=100,000/mm3), liver function (total bilirubin \>=3 mg/dL and AST/ALT \>=150 IU/L), and renal function (creatinine clearance \>=45 mL/min) 6. Adequate oral intake 7. Provided written informed consent -
Exclusion criteria
1. Patients with interstitial pneumonia or pulmonary fibrosis 2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe active infection 4. Patients with moderate or marked pleural effusion or ascites necessitating drainage 5. Patients with a history of severe drug allergy 6. Patients with other serious comorbid disease 7. Patients who are pregnant or lactating, or have an intention to get pregnant 8. Patients with mental disease 9. Patients who are judged inappropriate for the entry into the study by the principle doctor \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | Probability of 1-year survival (%) | The primary endpoint is designated to evaluate overall survival rate at 12-month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Every 3 months, up to 24 months | The investigators will conduct CT test every 3 months in order to measure the tumor size of each patient and evaluate the best tumor response according to RECIST criteria. |
| Progression free survival | Every 3 months, up to 24 months | In oredr to research the progression survival, the investigators will check the presence of progression disease for each patient every three months. |
| Number of Participants with Adverse Events as a Measure of Safety | 24 months | The investigators will examine the frequency and the degree of each side effect that will appear to the patient at each course of chemotherapy . |
Countries
Japan
Outcome results
None listed