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

Phase 1

Completed

• Conditions: Biliary Tract Cancer
• Interventions: Drug: Gemcitabine; Drug: S-1

• Registration Number: NCT01291615
• Lead Sponsor: Kansai Hepatobiliary Oncology Group

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-02-06
• Study First Posted: 2011-02-08
• Primary Completion: 2012-10
• Study Completion: 2013-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-21
• Last Update Posted: 2014-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine group	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
S-1 group	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

Primary Outcome Measures

Name	Time	Method
frequency in adverse events	up to 12 weeks	The purpose of this study is to decide maximum tolerated dose and recommended dose. Recommended dose is a dose which would induce dose-limiting toxicity in 10% of participants. This will be calculated by continual reassessment method.

Trial Locations

Locations (1)

Osaka University, Graduate School of Medicine; 🇯🇵 Osaka, Japan