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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004776
Receipt No. R000005687
Scientific Title Safety and Efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma
Date of disclosure of the study information 2010/12/22
Last modified on 2018/02/13

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Basic information
Public title Safety and Efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma
Acronym Safety and Efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma
Scientific Title Safety and Efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma
Scientific Title:Acronym Safety and Efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma
Region
Japan

Condition
Condition Cholangiocellular Carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin for Patients with Unresectable Cholangiocellular Carcinoma
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Key secondary outcomes Overall Survival (OS)
Progression Free Survival (PFS)
1-year Survival Rate
6 months Progression Free Survival
Response Rate (RR)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cisplatin Based Transarterial Chemo-Embolization in Combination with Gemcitabine and Cisplatin
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 aged 20 Years or over
2) Patients who were fully informed of the study beforehand and signed the informed consent to participate in the study
3) Patients diagnosed with typical cholangiocellular carcinoma by histologically proven and diagnostic imaging
4) Patients with tumor in the liver
5) Patients in whom complete resection of the tumor by hepatectomy cannot be expected to succeed.
6) Patients with an ECOG PS(Performance Status) Score of 0 or 1.
7) Patients who are expected to live more than 12 weeks.
8) Adequate organ function
Key exclusion criteria 1) History of malignant tumor
2) Severe cardiac disease
3) Active infection
4) History of HIV infection
5) Renal dialysis
6) Intracranial tumor
7) Clinically uncontrolled ascites or pleural effusion
8) Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
9) Prior history of chemotherapy with gemcitabine and cisplatin
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Yokosuka
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuou-ku, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sadahisa Ogasawara
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email ogasawaras@graduate.chiba-u.jp

Sponsor
Institute Chiba University Hospital
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
2010 Year 12 Month 22 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
2010 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 22 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
2010 Year 12 Month 22 Day
Last modified on
2018 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005687

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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