Status:
COMPLETED
Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
Lead Sponsor:
Kansai Hepatobiliary Oncology Group
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after hemihepatectomy.
Detailed Description
There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. For example, our ...
Eligibility Criteria
Inclusion
- Biliary tract cancer (BTC) (\>= Unio Internationalis Contra Cancrum (UICC) Stage IB), adenocarcinoma
- R0 or R1 resection
- no obvious recurrent lesion
- 20 years old or more
- Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1
- The patient underwent no other treatment than surgery for BTC
- Neutrophil must be over 1500/μl, Hemoglobin must be over 9.0g/dL, platelet must be over 100,000/μl, Aspartate transaminase (AST) and Alanine aminotransferase (ALT) must be less than 150 IU/L, total bilirubin must be less than 1.5 mg/dL, Creatinine must be less than 1.2 mg/dl, and Creatinine clearance must be over 60 mL/min
- The patient can intake drugs per os.
- From 4 to 12 weeks after the surgery
- Written informed consent
Exclusion
- Existence of active double cancer
- The patient suffered from severe drug allergy
- Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
- Any active infections exist.
- Pregnancy
- Severe mental disorder
- Others
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01815307
Start Date
January 1 2013
End Date
December 1 2017
Last Update
May 16 2018
Active Locations (1)
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1
Osaka University, Graduate School of Medicine
Osaka, Japan, 565-0871