UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007563 |
|---|---|
| Receipt number | 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 12:24:29 |
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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
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
yhamamoto@z2.keio.jp
Sponsor or person
Institute
Keio University, School of Medicine, Div. of Gastroenterology, Dept.of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008933
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