UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009945 |
|---|---|
| Receipt number | R000011553 |
| Scientific Title | Random Phase II Study of GEM versus S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1208) |
| Date of disclosure of the study information | 2013/02/04 |
| Last modified on | 2018/06/24 08:30:03 |
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Basic information
Public title
Random Phase II Study of GEM versus S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1208)
Acronym
Random P2 study of GEM vs S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1208)
Scientific Title
Random Phase II Study of GEM versus S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1208)
Scientific Title:Acronym
Random P2 study of GEM vs S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1208)
Region
| Japan |
Condition
Condition
Biliary Tract Cancer (including Intrahepatic Cholangiocarcinoma)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare efficacy and safety of GEM versus S-1 adjuvant therapy after hemihepatctomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1 year recurrent free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gemcitabine
1000mg/m2, day 1 every 2 weeks.
Interventions/Control_2
S-1
80mg/m2/day, day 1-28, every 6 weeks.
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 (>= UICC Stage IB), adenocarcinoma
2) R0 or R1 resection
3) no obvious recurrent lesion
4) 20 years old or more
5) ECOG PS 0 or 1
6) No other treatment than surgery
7) Neutrophil >= 1500/uL, PLT >=100,000/uL, AST, ALT <= x5 ULN, Total Bilirubin <= x3 ULN, crtn <= 1.2 mg/dL, Creatinine clearance >= 60 mL/min
8) Oral drug intake
9) 4 - 12 weeks after the surgery
10) Written informed consent
Key exclusion criteria
1) Active double cancer
2) Severe drug allergy
3) Severe complications (IP, HF, RF, LF, ileus, DM, etc)
4) Active infections
5) Pregnancy
6) Severe mental disorder
7) Others
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagano |
Organization
Osaka University, Graduate School of Medicine
Division name
Surgery
Zip code
Address
Yamadaoka 2-2, E2, Suita city, Osaka, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Kobayashi |
Organization
Osaka University
Division name
Surgery
Zip code
Address
Yamadaoka 2-2, E2, Suita city, Osaka, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Kansai Hepatobiliary Oncology Group (KHBO)
Institute
Department
Personal name
Funding Source
Organization
Kansai Hepatobiliary Oncology Group (KHBO)
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 04 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 23 | 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
| 2013 | Year | 02 | Month | 04 | Day |
Last modified on
| 2018 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011553
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
