UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000919 |
|---|---|
| Receipt number | R000001105 |
| Scientific Title | Phase II study of S-1 in patients with gemcitabine-refractory advanced biliary tract cancer |
| Date of disclosure of the study information | 2007/12/01 |
| Last modified on | 2019/01/15 13:09:15 |
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Basic information
Public title
Phase II study of S-1 in patients with gemcitabine-refractory advanced biliary tract cancer
Acronym
Phase II study of S-1 in patients with gemcitabine-refractory advanced biliary tract cancer
Scientific Title
Phase II study of S-1 in patients with gemcitabine-refractory advanced biliary tract cancer
Scientific Title:Acronym
Phase II study of S-1 in patients with gemcitabine-refractory advanced biliary tract cancer
Region
| Japan |
Condition
Condition
Patients with gemcitabine-refractory advanced biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity of S-1 for gemcitabine-refractory advanced biliary tract cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
Toxicity, 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
S-1 was administered until disease progression.
Dose of S-1: 80mg/m2 for 28 days, followed by a rest period of 14 days.
BSA / daily dose
<=1.25 m2 / 80 mg
1.25 m2 - 1.5 m2 / 100 mg
>1.5 m2 / 120 mg
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Biliary tract cancer histologically confirmed as adenocarcinoma
2) Progression during GEM-based first-line chemotherapy
3) Oral intake is possible
4) Measurable or assessable metastatic lesion(s)
5) Age of more than 20 years
6) ECOG performance status (PS) of 0 to 2
7) Interval of at least 3 weeks between last chemotherapy treatment and start of present chemotherapy regimen
8) Adequate organ function
9) Written informed consent
Key exclusion criteria
1) Regular use of fenitoin, warfarin or frucitocin
2) History of fluorinated pyrimidine use
3) Severe diarrhea
4) Severe mental disorder
5) Severe infection
6) Severe complication
7) Intestinal pneumonia or lung fibrosis
8) History of chest radiotherapy
9) Massive pleural or abdominal effusion
10) Symptomatic brain metastasis
11) History of other active malignancy
12) Pregnancy or the desire to preserve fecundity
13) Inadequate physical condition, as diagnosed by primary physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Furuse |
Organization
National Cancer Center Hospital East
Division name
Hepatobiliary and Pancreatic Oncology Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
jfuruse@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiichiro Suzuki |
Organization
National Cancer Center Hospital East
Division name
Hepatobiliary and Pancreatic Oncology Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
eisuzuki@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Hepatobiliary and Pancreatic Oncology Division
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2007 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2007 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | 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
| 2007 | Year | 12 | Month | 01 | Day |
Last modified on
| 2019 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001105
