KCT0003726
Terminated
未知
A phase III clinical study to compare paclitaxel (Genexol®-PM) in combination with standard therapy (gemcitabine/cisplatin) and standard therapy alone (gemcitabine/cisplatin) in patients with advanced biliary tract cancer
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Asan Medical Center
- Enrollment
- 220
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients between 19 and 79 years old
- •\- Cytologically or histologically confirmed adenocarcinoma of biliary tract (gallbladder, intrahepatic, and extrahepatic bile ducts) with or without measurable lesion according to RECIST version 1\.1
- •\- Locally advanced unresectable, initially metastatic, and recurred disease
- •\- At least one or more evaluable lesions without prior radiotherapy
- •\- Patients with or without prior external or internal biliary drainage procedure (e.g., percutaneous transhepatic biliary drainage, endoscopic retrograde biliary drainage)
- •\- No previous chemotherapy except adjuvant chemotherapy with fluoropyrimidine\-based regimen which completed 6 months or before
- •\- Eastern Cooperative Oncology Group (ECOG) performance status 0 \~ 2
- •\- Adequate bone marrow function as defined by platelets \= 100 x 109/L and neutrophils \= 1\.5 x 109/L
- •\- Adequate renal function, with serum creatinine \< 1\.5 x upper limit of normal (ULN)
- •\- Adequate hepatic function with serum total bilirubin \< 1\.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 5 x ULN
Exclusion Criteria
- •\- Age\=80 years
- •\- Histologically diagnosed adenosquamous carcinoma
- •\- AoV cancer
- •\- History of severe neurologic disorder or psychiatric disorder
- •\- Radiation therapy taken within 4 weeks
- •\- Gastrointestinal obstruction
- •\- Severe gastrointestinal bleeding
- •\- Medical history with coronary angioplasty, stent insertion, bypass within 6months
- •\- Myocardial infarction or other clinically significant heart disease within 6 months of initiation of the study treatment
- •\- High risk of cardiovascular conditions (including patients with recent coronary stent implantations, with myocardial infarction within 6 months, and with arrhythmia with unstable symptoms)
Outcomes
Primary Outcomes
Not specified
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