UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012071 |
|---|---|
| Receipt number | 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 14:30:57 |
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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
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
aikata@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013631
| Research Plan | |
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| 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 |
