UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001116
Receipt number 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 04:59:13

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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 or person

Institute

Japanese Study Group for Pediatric Liver Tumors

Institute

Department

Personal name



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

Value
https://center6.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