UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030980 |
|---|---|
| Receipt number | R000035372 |
| Scientific Title | Multidisciplinary treatment of cholangiocarcinoma -impact of induction chemotherapy followed by surgery- |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2021/01/26 09:43:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multidisciplinary treatment of cholangiocarcinoma
-impact of induction chemotherapy followed by surgery-
Acronym
Multidisciplinary treatment of cholangiocarcinoma
Scientific Title
Multidisciplinary treatment of cholangiocarcinoma
-impact of induction chemotherapy followed by surgery-
Scientific Title:Acronym
Multidisciplinary treatment of cholangiocarcinoma
Region
| Japan |
Condition
Condition
cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the outcome and future issues of neoadjuvand treatment, using Gemcitabine plus TS-1 (GS), followed by curative-intent operation for cholangicarcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival: OS
Key secondary outcomes
progression free survival, safety evaluation, pathological effects of neoadjuvant treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
two cycles of chemotherapy with gemcitabine (800 mg/m2 on days 7 and 21) plus S-1 (80 mg/body daily on days 1 to 21 every 4 weeks), followed by surgery
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) cholangiocarcinoma as following: (1) main, bilateral, or contralateral portal vein and/or hepatic artery invasion with or without possible vascular reconstruction; or (2) invasion of the right side of the umbilical portion (U portion) and the left side of the origin of the right posterior portal vein (P portion); or (3) regional lymph node metastasis.
2) Performance Status (ECOG):0 or 1
3) Patient's agreement to this study
Key exclusion criteria
1) patients with allergic reaction for TS-1 and gemecitabine
2) patients with severe hepatic disorder (AST or AL: 3 times of normal range or more)
3) patients with severe repeated cholangitis
4) Patients found to be wanting by principal investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Isaji |
Organization
Mie University school of medicine
Division name
Hepatobiliary Pancreatic and Transplant Surgery
Zip code
5148507
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-232-1111
isaji-s@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Naohisa |
| Middle name | |
| Last name | Kuriyama |
Organization
Mie University school of medicine
Division name
Hepatobiliary Pancreatic and Transplant Surgery
Zip code
5148507
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-232-1111
Homepage URL
naokun@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
other
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
The Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie, Japan
Tel
059-232-1111
kk-sien@mo.medic.mie-u.ac.jp
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
| 2018 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
143
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035372
