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

Primary Purpose

Biliary Tract Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Gemcitabine
S-1
Sponsored by
Kansai Hepatobiliary Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osaka University, Graduate School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gemcitabine group

S-1 group

Arm 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

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

Outcomes

Primary Outcome Measures

frequency in adverse events
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.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2011
Last Updated
October 21, 2014
Sponsor
Kansai Hepatobiliary Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT01291615
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kansai Hepatobiliary Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine group
Arm Type
Experimental
Arm 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
Arm Title
S-1 group
Arm Type
Experimental
Arm Description
S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
gemzer
Intervention 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
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
TS-1
Intervention Description
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 Measure Information:
Title
frequency in adverse events
Description
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.
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Nagano, MD, PhD
Organizational Affiliation
Osaka University Graduate School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Osaka University, Graduate School of Medicine
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25074036
Citation
Kobayashi S, Nagano H, Sakai D, Eguchi H, Hatano E, Kanai M, Seo S, Taura K, Fujiwara Y, Ajiki T, Takemura S, Kubo S, Yanagimoto H, Toyokawa H, Tsuji A, Terajima H, Morita S, Ioka T. Phase I study of adjuvant gemcitabine or S-1 in patients with biliary tract cancers undergoing major hepatectomy: KHBO1003 study. Cancer Chemother Pharmacol. 2014 Oct;74(4):699-709. doi: 10.1007/s00280-014-2543-4. Epub 2014 Jul 30.
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Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

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