UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009536 |
|---|---|
| Receipt number | R000011196 |
| Scientific Title | Phase 1 study of Gemcitabine, Cisplatin and S-1 combination chemotherapy in patients with advanced biliary tract cancer |
| Date of disclosure of the study information | 2012/12/13 |
| Last modified on | 2012/12/12 20:58:19 |
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Basic information
Public title
Phase 1 study of Gemcitabine, Cisplatin and S-1 combination chemotherapy in patients with advanced biliary tract cancer
Acronym
Phase 1 study of Gemcitabine, Cisplatin and S-1 combination chemotherapy in patients with advanced biliary tract cancer
Scientific Title
Phase 1 study of Gemcitabine, Cisplatin and S-1 combination chemotherapy in patients with advanced biliary tract cancer
Scientific Title:Acronym
Phase 1 study of Gemcitabine, Cisplatin and S-1 combination chemotherapy in patients with advanced biliary tract cancer
Region
| Japan |
Condition
Condition
biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum-tolerated dose (MTD) and recommended dose (RD) of Gemcitabine, Cisplatin and S-1 combination chemotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
To determinate MTD and RD.
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gemcitabine: day1, 15
Cisplatin: day1, 15
S-1: day1-7, day15-21
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)Histologically or cytologically proven biliary tract cancer.
2)Recurrent or unresectable Advanced Biliary Tract Cancer.
3)No prior chemothearpy or radiotherapy for Biliary Tract Cancer.
4)Aged 20 to 79 years old.
5)ECOG performance status of 0 or 1.
6)Adequate organ function.
7)Oral intake is possible.
8)Written informed consent.
Key exclusion criteria
1)Simultaneous or metachronous double cancers.
2)Severe complications.
3)The case suspected of infection with feaver.
4)A history of motor paralysis or peripheral neuropathy or edema.
5)Pleural or cardiac effusion requiring treatment.
6)Massive abdominal effusion.
7)Pregnancy or the desire to preserve fecundity.
8)Active lung disease such as interstitial pneumonia or pulmonary fibrosis.
9)Mental disease or psychotic manifestation.
10) A history of serious drug allergy.
11)A history of sever allergic reaction with gemcitabine or cisplatin or S-1.
12)Being treated with other pyrimidine fluoride antineoplastic agents.
13)Being treated with flucytosine.
14)Any patients judged by the investigator to be unfit to participate in the study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kida |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
042-748-9111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kida |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
042-748-9111
Homepage URL
Sponsor or person
Institute
Kitasato University School of Medicine
Department of Gastroenterology Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
北里大学東病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 12 | Day |
Last modified on
| 2012 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011196
