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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001116
Receipt No. R000001351
Scientific Title JPLT2 protocol (CITA and ITEC regimen)for the pediatric liver tumor in Japan
Date of disclosure of the study information 2008/04/09
Last modified on 2015/10/11

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Basic information
Public title JPLT2 protocol (CITA and ITEC regimen)for the pediatric liver tumor in Japan
Acronym JPLT(Japanese Study Group for Pediatric Liver Tumor)-2 protocol
Scientific Title JPLT2 protocol (CITA and ITEC regimen)for the pediatric liver tumor in Japan
Scientific Title:Acronym JPLT(Japanese Study Group for Pediatric Liver Tumor)-2 protocol
Region
Japan

Condition
Condition hepatoblastoma
hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The incident rate of the childhood liver tumors is only 2-3 per 100,000 and only 30-40 cases occurs a year in Japan. Therefore, nationwide clinical study is needed to improve the prognosis of these patients. In 1991, Japanese Study Group for Pediatric Liver Tumor (JPLT-1) launched. And JPLT-2 protocol was started at 1998. We observe the results of JPLT-2 protocol in comparison to those of JPLT-1 and clarify the clinical problems. Then, we will establish the standard therapy for pediatric liver tumors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Effect of tumor reduction
Improvement of event-free and overall survivals
Safety
Key secondary outcomes Pancytopenia
Digestive organ dysfunction
Late complications (cardiac dysfunction, growth disorder, hearing disorder)

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
0 years-old <=
Age-upper limit
15 years-old >
Gender Male and Female
Key inclusion criteria 1. A child between 6 months and 5 years of age has liver tumors detected by imaging and shows an abnormally high level of serum AFP.(Note, however, that it is necessary to exclude the metastatic liver tumor by totally diagnostic imaging. In addition, when chemotherapy will be performed ahead, pathological diagnosis by biposy is preferable to be done for accurate diagnosis.)
2. A child under 6 months or more 5 years of age had intrahepatic tumor which was diagnosed by pathology.
3 In cases with liver tumor whose serum AFP is normal level, pathological diagnosis by biopsy is obtained regardless of age.
Key exclusion criteria Note that, even if an intrahepatic tumor, the benign liver tumor, hepatocellular carcinoma, and metastatic liver tumors should be excluded.

Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiso Hiyama
Organization Hiroshima University
Division name Natural Science Center for Basic Research and Development
Zip code
Address 1-2-3,Kasumi,Minami-ku,Hiroshima
TEL 082-257-5951
Email eiso@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Ogura
Organization Hiroshima university hospital
Division name Pediatric Surgery
Zip code
Address 1-2-3,Kasumi,Minami-ku,Hiroshima
TEL 082-257-5216
Homepage URL http://home.hiroshima-u.ac.jp/jpltstudy/index.html
Email kogura@hiroshima-u.ac.jp

Sponsor
Institute Japanese Study Group for Pediatric Liver Tumors
Institute
Department

Funding Source
Organization Foundation from Children's cancer assotiation of Japan.
Mitsui Life Social Walfare Foundation.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 広島大学病院(広島県)他117施設

Other administrative information
Date of disclosure of the study information
2008 Year 04 Month 09 Day

Related information
URL releasing protocol http://home.hiroshima-u.ac.jp/jpltstudy/index.html
Publication of results Partially published

Result
URL related to results and publications http://home.hiroshima-u.ac.jp/eiso/
Number of participants that the trial has enrolled
Results
For interm analysis of 315 cases, the 5-year overall survival rate (OS) in nonmetastatic cases was 100% for PRETEXT I, 87.1% for PRETEXT II, 89.7% for PRETEXT III, and 78.3% for PRETEXT IV. The 5-year OS in metastatic cases was 43.9%.
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
2006 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
2016 Year 12 Month 01 Day
Date trial data considered complete
2017 Year 03 Month 01 Day
Date analysis concluded
2018 Year 03 Month 01 Day

Other
Other related information Event-free survival (2 years, 5years)
Overall survival (2 years, 5years)

The patients without metastatic cases were moved into JPLT3-S or 3-I protocols.

Management information
Registered date
2008 Year 04 Month 09 Day
Last modified on
2015 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001351

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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