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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009831
Receipt No. R000011517
Scientific Title A multicenter phase II trial of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Date of disclosure of the study information 2013/02/01
Last modified on 2019/12/27

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Basic information
Public title A multicenter phase II trial of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Acronym A multicenter phase II trial of pre-operative chemotherapy with GCS for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Scientific Title A multicenter phase II trial of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Scientific Title:Acronym A multicenter phase II trial of pre-operative chemotherapy with GCS for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Region
Japan

Condition
Condition biliary tract cancers
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and the safety
of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Curative resection rate
Key secondary outcomes

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 Pre-operative chemotherapy (GCS) 3 cycles-FDG-PET-surgery
GCS therapy
Gemcitabine 1000mg/m2/day1
Cisplatin 25mg/m2/day1
S-1 100mg/body/day1-7
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.Patients with radiologically proven bilialy tract cancer.
2.No extrahepatic disease.
3.No prior therapy.
4.The function of the liver is kept as satisfied after hepatectomy.
5.No chronic liver damage.
6.Patients of age over 20 years.
7.ECOG performance status of 0-1.
8.Sufficient organ function.
9.Patients obtained written informed consent.
Key exclusion criteria 1. Massive abdominal effusion requiring treatment.
2. Active concomitant malignancy.
3. The case suspected of infection.
4. Patients with water solubility diarrhea.
5. Mental disease or psychotic manifestation.
6. Under continuous steroid therapy.
7. Patients with acute myocardial infaction.
8. Patients with severe complications.
9. Pregnancy or the desire to preserve fecundity.
10. Serious drug hypersensitivity or a history of drug allergy.
11. Any patients judged by the investigator to be unfit to participate in the study.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Etsuro Hatano
Organization Kyoto University Graduate School of Medicine
Division name Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Seo
Organization Kyoto University Graduate School of Medicine
Division name Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL 075-751-3242
Homepage URL
Email rutosa@kuhp.kyoto-u.ac.jpKH

Sponsor
Institute KHBO
Institute
Department

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
Email

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 01 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 Completed
Date of protocol fixation
2013 Year 01 Month 17 Day
Date of IRB
2013 Year 02 Month 21 Day
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2019 Year 03 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
2013 Year 01 Month 21 Day
Last modified on
2019 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011517

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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