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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012071
Receipt No. R000013631
Scientific Title The combination therapy of HAIC and RT for tumor thrombosis.
Date of disclosure of the study information 2013/10/18
Last modified on 2019/03/20

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Basic information
Public title The combination therapy of HAIC and RT for tumor thrombosis.
Acronym The combination therapy of HAIC and RT for tumor thrombosis.
Scientific Title The combination therapy of HAIC and RT for tumor thrombosis.
Scientific Title:Acronym The combination therapy of HAIC and RT for tumor thrombosis.
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 prognosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Local tumor control rate
Key secondary outcomes Overall survival rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1) 20 Years and older.
2) Life expectancy of at least 12 weeks at the pre-treatment evaluation.
3) Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or MRI.
4) Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization.
5) At least 4 weeks since last therapy for HCC.
6) Intrahepatic tumor which affects patient'prognosis.
7) Extrahepatic tumor apread which not affects patient's prognosis.
8) ECOG Performance status of 0 or 1.
9) Child-Pugh 5,6,7
10) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements:
Granulocyte >= 3000/mm3
Platelet count >= 50,000 /mm3 Hemoglobin >= 8.5 g/dl
Total serum bilirubin <= 3 mg/dl
serum albimin>=2.8
Serum creatinine <= 1.5 mg/dl
prothrombin consumption test>=50%
Amylase <= 2 times upper limit of normal
11) Written Informed Consent must be obtained.
Key exclusion criteria 1) With other malignant disease.
2) A pregnant woman, or a woman suspected of pregnancy.
3) With severe infectious disease.
4) With history of severe allergy.
5) With severe renal function disease. 6) With severe allergy for 5FU or CDDP.
7) With severe bone marrow supression.
8) Esophageal and/or gastric varices which has high risk of bleeding and clinically significant gastro-
intestinal bleeding.
9) Serious hypertension
10) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kazuaki Chayama
Organization Hiroshima university hospital
Division name Departments of Gastroenterology and Metabolism
Zip code
Address 1-2-3 Kasumi, Minamiku, Hiroshima
TEL 082-257-5192
Email Chayama@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Aikata
Organization Hiroshima university hospital
Division name Departments of Gastroenterology and Metabolismepartments of Gastroenterology and Metabolism
Zip code
Address 1-2-3 Kasumi, Minamiku, Hiroshima
TEL 082-257-5192
Homepage URL
Email aikata@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima university hospital
Institute
Department

Funding Source
Organization Hiroshima university hospital
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
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 10 Month 18 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 09 Month 10 Day
Date of IRB
2013 Year 10 Month 07 Day
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2017 Year 09 Month 30 Day
Date analysis concluded
2017 Year 09 Month 30 Day

Other
Other related information We perform radiotherapy as additional treatment combined with HAIC for hepatocellular carcinoma tumor thrombosis. Further we examine the effectiveness and safety and follow up them after this treatment.

Management information
Registered date
2013 Year 10 Month 18 Day
Last modified on
2019 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013631

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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