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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007563
Receipt No. R000008933
Scientific Title phase I/II trial of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer
Date of disclosure of the study information 2012/03/23
Last modified on 2017/04/21

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Basic information
Public title phase I/II trial of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer
Acronym phase I/II trial of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer
Scientific Title phase I/II trial of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer
Scientific Title:Acronym phase I/II trial of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer
Region
Japan

Condition
Condition Locally advanced or metastatic biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I
Primary objective is to estimate the maximum tolerated dose(MTD)and recommended dose(RD)of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer
PhaseII
Primary objective is to evaluate the efficacy and safety of Gemcitabine/CDDP/S-1 for locally advanced or metastatic biliary tract cancer when administered at recommended dose estimated in Phase I
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes PhaseI
estimate the maximum tolerated dose(MTD)and recommended dose(RD)of Gemcitabine/CDDP/S-1

PhaseII
Progression free survival
Key secondary outcomes PhaseI
Adverse events, pharmacokinetics

PhaseII
Overall survival, Response Rate, Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine/CDDP/S-1 combination chemotherapy is conducted. CDDP (25mg/m2) and Gemcitabine (1000mg/m2) are administered intravenously at day 1 and 8. S-1 is orally administered twice daily at dose levels from 60mg/m2 to 80mg/m2 for 14 days followed by 7 days rest according to body surface area

pharmacokinetics
Blood sample is obtained from day 1 to day 2 in order to evaluate the pharmacokinetics of Gemcitabine/CDDP/S-1 combination chemotherapy

PhaseII
CDDP(25mg/m2)and Gemcitabine (1000mg/m2)are administered intravenously at day 1 and 8. S-1 is orally administered twice daily at recommended dose estimated in phaseI for 14 days followed by 7 days rest according to body surface area.It is assumed that three weeks is one course and combination chemotherapy repeat until disease progression or discontinuation because of adverse
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1 biliary tract cancer confirmed
adenocarcinoma or squamous cell cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer)
2 in operable advanced biliary tract
cancer (include locally advanced or recurence)
The presence or absence of measurable lesion does not matter.
The patient with the measurable lesion conducting an examination for image within 28 days before registration.
3 with no prior therapy except for resection
Patient who underwent adjuvant chemotherapy could be registered, if recurrence is confirmed more than 24 weeks from last administration day.
4 age 20 to 80 at registration
5 PS 0-1
6 sufficient function of important organs
WBC: >=3,500/mm3 and <=12,000/mm3
Neu:>=2,000/mm3
Platelet: >=100,000/mm3
Hem: >=10.0g/dl
GOT(AST): <= 100IU/l(or 150U/L if biliary drainage were present)
GPT(ALT): <= 100IU/l(or 150U/L if biliary drainage were present)
sT.bil: <=2.0mg/dl(or 3.0mg/dl if biliary drainage were present)
serum Cr: =< 1.2mg/dL
Ccr:>=60 ml/min/body
7 oral intake
8 clinically no abnormal findings to become the problem with an electrocardiogram within 28 days before registration
9 written informed consent
Key exclusion criteria 1 biliary tract cancer confirmed
adenocarcinoma or squamous cell cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer)
2 in operable advanced biliary tract
cancer (include locally advanced or recurence)
The presence or absence of measurable lesion does not matter.
The patient with the measurable lesion conducting an examination for image within 28 days before registration.
3 with no prior therapy except for resection
Patient who underwent adjuvant chemotherapy could be registered, if recurrence is confirmed more than 24 weeks from last administration day.
4 age 20 to 80 at registration
5 PS 0-1
6 sufficient function of important organs
WBC: >=3,500/mm3 and <=12,000/mm3
Neu:>=2,000/mm3
Platelet: >=100,000/mm3
Hem:>=10.0g/dl
GOT(AST): <= 100IU/l(or 150U/L if biliary drainage were present)
GPT(ALT): <= 100IU/l(or 150U/L if biliary drainage were present)
sT.bil: <=2.0mg/dl(or 3.0mg/dl if biliary drainage were present)
serum Cr: =< 1.2mg/dL
Ccr:>=60 ml/min/body
7 oral intake
8 clinically no abnormal findings to become the problem with an electrocardiogram within 28 days before registration
9 written informed consent
10 with interstitial pneumonia and lungs fiber syndrome
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshifumi Hibi
Organization keio University, school of medicine
Division name Div. of Gastroenterology, Dept. of Internal Medicine
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email yashmmt1971@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Hamamoto
Organization Keio University, school of medicine
Division name Div. of Gastroenterology, Dept. of Internal Medicine
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email yhamamoto@z2.keio.jp

Sponsor
Institute Keio University, School of Medicine, Div. of Gastroenterology, Dept.of Internal Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor Kanagawa Cancer Center
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 慶應義塾大学 医学部 消化器内科

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
2016 Year 12 Month 01 Day
Date trial data considered complete
2016 Year 12 Month 01 Day
Date analysis concluded
2016 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 23 Day
Last modified on
2017 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008933

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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