- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01291615
Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
October 21, 2014 updated by: Kansai Hepatobiliary Oncology Group
To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant therapy after hemihepatectomy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Osaka, Japan, 565-0871
- Osaka University, Graduate School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Gemcitabine group
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
|
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:
|
EXPERIMENTAL: S-1 group
S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
frequency in adverse events
Time Frame: 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.
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up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (ACTUAL)
October 1, 2012
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
January 3, 2011
First Submitted That Met QC Criteria
February 6, 2011
First Posted (ESTIMATE)
February 8, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 23, 2014
Last Update Submitted That Met QC Criteria
October 21, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Biliary Tract Diseases
- Biliary Tract Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- KHBO1003
- UMIN000004682 (REGISTRY: UMIN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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