Status:
UNKNOWN
A Phase II Trial of Preoperative Chemotherapy for Biliary Tract Cancer (BTC) With Node Metastasis
Lead Sponsor:
Kansai Hepatobiliary Oncology Group
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET.
Detailed Description
Biliary tract cancer is one of the most lethal malignancies worldwide, with surgery representing the only potentially curative treatment for this disease. However, many patients are diagnosed as far a...
Eligibility Criteria
Inclusion
- Patients with radiologically proven biliary tract cancer.
- No extra-hepatic disease.
- No prior therapy.
- The function of the liver is kept as satisfied after hepatectomy.
- No chronic liver damage.
- Patients of age over 20 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Sufficient organ function (neutrophil count \>=1,500/mm3 and platelet count \>=100,000/mm3, Hemoglobin \>=9.0g/dL, Aspartate transaminase (AST)/alanine aminotransferase (ALT) \<=150 IU/L, total bilirubin \<=1.5 mg/dL , creatinine \<=1.2 mg/dL , creatinine clearance \>=60 mL/min) 9.Patients obtained written informed consent.
Exclusion
- Massive abdominal effusion requiring treatment.
- Active concomitant malignancy.
- The case suspected of infection.
- Patients with water solubility diarrhea.
- Mental disease or psychotic manifestation.
- Under continuous steroid therapy.
- Patients with acute myocardial infarction.
- Patients with severe complications.
- Pregnancy or the desire to preserve fecundity.
- Serious drug hypersensitivity or a history of drug allergy.
- Any patients judged by the investigator to be unfit to participate in the study.
Key Trial Info
Start Date :
July 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01821248
Start Date
July 23 2013
End Date
February 1 2019
Last Update
February 21 2019
Active Locations (1)
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1
Kyoto University Hospital
Kyoto, Japan, 606-8507