Trial | NCT01291615  Report issue

Official Title

Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    6
To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant therapy after hemihepatectomy
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 Started
Dec 31
2010
Primary Completion
Oct 31
2012
Study Completion
May 31
2013
Last Update
Oct 23
2014
Estimate

Drug Gemcitabine

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

  • Other names: gemzer

Drug S-1

S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks.

  • Other names: TS-1

Gemcitabine group Experimental

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

S-1 group Experimental

S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks

Criteria 

Inclusion Criteria:

Biliary tract cancer (>= UICC Stage IB)
R0 or R1 resection due to biliary tract cancer (BTC)
ECOG performance status must be 0 or 1
The patient underwent no other treatment than surgery for BTC
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.
The patient can intake drugs per os.
From 4 to 12 weeks after the surgery
Written informed consent

Exclusion Criteria:

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
No Results Posted