Brief Title
Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
Official Title
Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
Brief Summary
To decide maximum tolerated dose and/or recommended dose of Gemcitabine or 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 preliminary results showed that regular gemcitabine administration
(1000mg/m2, day1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe
leukocytopenia and/or thrombocytopenia. Herein, we planned this study to decide more safety
adjuvant protocol(recommend dose) for gemcitabine and S-1 after hemihepatectomy using
continual reassessment method analysis. In this study, we decided that tolerable ratio of
dose-limiting toxicity would be less than 10%.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
frequency in adverse events
Condition
Biliary Tract Cancer
Intervention
Gemcitabine
Study Arms / Comparison Groups
Gemcitabine group
Description: 800mg/m2 - 1000mg/m2, day 1 every 3 weeks. day 1, 15 every 4 weeks. day 1, 8 every 3 weeks. day 1, 8, 15, every 4 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
6
Start Date
December 2010
Completion Date
May 2013
Primary Completion Date
October 2012
Eligibility Criteria
Inclusion Criteria:
1. Biliary tract cancer (>= UICC Stage IB)
2. R0 or R1 resection due to biliary tract cancer (BTC)
3. ECOG performance status must be 0 or 1
4. The patient underwent no other treatment than surgery for BTC
5. Neutrophil must be over 1500/μl, platelet must be over 100,000/μl, AST and ALT must be
less than five times the normal limit, total bilirubin must be less than three times
the normal limit, and creatinin must be less than 1.2 mg/dl.
6. The patient can intake drugs per os.
7. From 4 to 12 weeks after the surgery
8. Written informed consent
Exclusion Criteria:
1. Existence of active double cancer
2. The patient suffered from severe drug allergy
3. Sever complications (interstitial pneumonia, heart failure, renal failure, liver
failure, ileus, incontrollable diabetes mellitus, and so on)
4. Any active infections exist.
5. Pregnancy
6. Severe mental disorder
7. Others
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Hiroaki Nagano, MD, PhD, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT01291615
Organization ID
KHBO1003
Secondary IDs
UMIN000004682
Responsible Party
Sponsor
Study Sponsor
Kansai Hepatobiliary Oncology Group
Study Sponsor
Hiroaki Nagano, MD, PhD, Study Director, Osaka University Graduate School of Medicine
Verification Date
October 2014