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UMIN ID:

Recruitment status Completed
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 2021/09/27

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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
1 days-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 Hiyama
Middle name
Last name Eiso
Organization Hiroshima University
Division name Natural Science Center for Basic Research and Development
Zip code 734-8551
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 Sho
Middle name
Last name Kurihara
Organization Hiroshima university hospital
Division name Pediatric Surgery
Zip code 734-8551
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) Children's Cancer Association of Japan

IRB Contact (For public release)
Organization Ethical Committee for Clinical Research of Hiroshima University
Address 1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
Tel 082-257-5907
Email gakujutu-kikaku@office.hiroshima-u.ac.jp

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 Published

Result
URL related to results and publications http://home.hiroshima-u.ac.jp/eiso/
Number of participants that the trial has enrolled 404
Results The 5-year event-free /overall survival rates of HB cases were 74.2%/89.9% for Stratum 1, 84.8%/90.8% for Stratum 2, 71.6%/85.9% for Stratum 3, and 59.1%/67.3% for Stratum 4. The outcomes for CITA responders were significantly better than non-responders, which remained poor despite salvage therapy with a second-line ITEC regimen or stem cell transplantation.
Results date posted
2021 Year 09 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Patients who are under 15 years of age with newly diagnosed hepatic primary malignancies: hepatoblastoma (HB) and hepatocellular carcinoma (HCC). Patients were excluded if they were currently receiving anticancer treatments or not expected to be alive more than 3 months, or not tolerable to chemotherapy.
Participant flow The patient is enrolled from the institutions registered in JPLT (the Japanese Study Group for Pediatric Liver Tumor).
Adverse events The late effects, ototoxicity, cardiotoxicity, and delayed growth, occurred in 61, 18, and 47 cases, respectively. Thirteen secondary malignant neoplasms (SMNs), including 10 leukemia occurred
Outcome measures Primary endpoints:
1 Event-free survival (5 years) in each stratum
2 Overall survival (5 years) in each stratum

Secondary endpoints
1 Toxicity and surgical outcome in all patient
2 Long-term toxicity including chemotherapy-related oto-, cardiac-, nephrotoxicity, maldevelopment, and second malignancies
3 Event-free survival (2 years) and overall survival (2 years)
4 Response for CITA and ITEC
5 Surgical resectability
6 Effectiveness of megachemotherapy
7 Prognostic factors: pathological classification and serum AFP levels
8 Molecular Analysis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 04 Month 01 Day
Date of IRB
2000 Year 03 Month 01 Day
Anticipated trial start date
2000 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
2021 Year 09 Month 27 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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