UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006548 |
|---|---|
| Receipt number | R000007758 |
| Scientific Title | PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer |
| Date of disclosure of the study information | 2011/10/17 |
| Last modified on | 2016/04/17 15:40:17 |
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Basic information
Public title
PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer
Acronym
PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer
Scientific Title
PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer
Scientific Title:Acronym
PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer
Region
| Japan |
Condition
Condition
advanced biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the dose for a phase 2 study, the DLTs, and the MTD.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
response rate, progression-free survival, overall survival
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
GEM: 1000 mg/m2 (day 1,8)
CDDP: 25 mg/m2 (day 1,8)
S-1: dose escalation (day1-14)
Every 3 weeks
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as advanced biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma and ampullary carcinoma
2) No previous therapy against biliary tract cancer
3) ECOG PS of 0 or 1
4) Aged 20 to 80 years old
5) Sufficient oral intake
6) Adequate organ functions
7) Written informed consent
Key exclusion criteria
1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant
3) Psychosis
4) Patients requiring systemic steroids medication
5) Interstitial pneumonia
6) Active bacterial or fungous infection
7) Severe complication
8) Patients who cannot receive neither iodic drug nor gadolinium because of drug allergy
9) Inadequate physical condition, as diagnosed by primary physician
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chigusa Morizane |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Oncology Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
cmorizan@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirokazu Shoji |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Oncology Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
hshouji@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26685318
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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 16 | Day |
Last modified on
| 2016 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007758
