UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009050 |
|---|---|
| Receipt number | R000010114 |
| Scientific Title | Risk stratified, multicentrial Phase II trials for hepatoblastoma without distant metastasis at diagnosis |
| Date of disclosure of the study information | 2012/10/05 |
| Last modified on | 2022/04/13 09:23:04 |
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Basic information
Public title
Risk stratified, multicentrial Phase II trials for hepatoblastoma without distant metastasis at diagnosis
Acronym
JPLT3-I protocol
Scientific Title
Risk stratified, multicentrial Phase II trials for hepatoblastoma without distant metastasis at diagnosis
Scientific Title:Acronym
JPLT3-I protocol
Region
| Japan |
Condition
Condition
hepatoblastoma
Classification by specialty
| Hepato-biliary-pancreatic surgery | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This trial is part of the third generation of clinical trials run by the JPLT group.Hepatoblastoma is the most common malignant liver neoplasm in children but this incidence is rare(approximately one by several ten thousands children a year).Therefore, 30-40 cases were registered to JPLT a year.To identify the new effective regimen, nationwide clinical trials are needed.JPLT was launched at 1991 and preformed JPLT1 and JPLT2 protocols.Althought surgical resection is the main stay of curative therapy for children with hepatoblastoma, only one-third to one-half of newly diagnosed patients with hepatoblastoma can be expected to have resectable disease at presentation.Patients who undergo a primary complete resection of their tumor have an excellent prognosis(90% event-free survival(EFS)).The use of chemotherapy has improved hepatoblastoma by increasing the number of patients whose tumors can be resected.On the other hand, in 2009, SIOPEL group(Europe) showed the efficancy of cis-platin monotherapy for such cases.In this JPLT3 study, we are willing to improve the outcome of the hepatoblastoma patients without distant metastasis at diagnosis using central pathalogical review and central imaging evaluation by the specialists.The improved points of this protocol are cis-platin(CDDP) monotherapy in which CDDP is administered with short duration(2 weeks duration) in standard risk patients and cis-platin/doxorubicin therapy with 3 weeks duration for intermediate HBLs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3-year progression free survival: 3-year PFS
Key secondary outcomes
Response rate to neo-adjuvant chemotherapy
The correlation with therapeutic choice by the efficacy of neo-adjuvant chemotherapy and outcome of the patient (Intermediate risk)
Complete resection rate
Surgical complication rate
Overall survival (OS)
Graded toxicities by CTCAE v. 4.0
Evaluation of biological, imaging. pathological data for new risk stratification
Identification of clinic-pathological risk factors
Identification of biologicall risk factors
Genetic analysis (only accepted cases)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
4 cycles with cisplatin (CDDP) and doxorubicin (DOX) (PLADO) therapy which are administered with 3 weeks duration.
In each cycle,CCDP DIV for 24 hours 80 mg/m2/day on Day 1.DOX IV for 24 hours 30 mg/m2/day on Day 2 and 3. After 4 courses of PLADO, radical surgery or liver transplantation should be performed. Then, 2 cycles of PLADO therapy as adjuvant chemotherapy.
(Surgical treatment is permitted after 5 or 6 cycle if preferable.)
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 | months-old | <= |
Age-upper limit
| 196 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed newly diagnosed hepatoblastoma or Primary liver tumor with high levels of serum AFP
Intermediate risk hepatoblastoma: by international risk stratification
PRETEXT I, II or III
Serum alpha-fetoprotein (AFP) > 100 micro-g/L
with additional PRETEXT criteria
and no distant metastasis (M, N3 factors)
2)Age <= 18 years and >=1 month
3)No previous chemotherapy
4)Written informed consent and national/local ethics committee and regulatory approval
5)Ability to comply with requirements for submission of material for central review (radiology, pathology and biology)
6)No severe organ failure: the cases who will be alive for more than 3 months
7)No active infections
8)Female patients of childbearing potential are not eligible unless a negative pregnancy text result has been obtained
9)Females of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method
Key exclusion criteria
Cases with one of the following factors
1)High and Standard risk hepatoblastoma:
Serum - Alpha-fetoprotein (AFP) <=100 micro-g/L
Distant metastases, any site (M1)
Lymph node metastases (N1, N2)
Tumor involving all 4 hepatic sections or PRETEXT I, II, or III without Additional PRETEXT factors
(Extrahepatic abdominal disease (E1, E1a, E2, E2a), Intraperitoneal hemorrhage or tumour rupture (H1), Involvement of the main portal vein (P2, P2a), Involvement of all three hepatic veins and/or the IVC (V3, V3a))
2)Hepatocellular carcinoma
3)Treatments was started at more than 15days after the report of biopsy or diagnosis
4)Abnormal renal function defined as GFR < 50% of the lower limit of normal for age, which over 2 years of age is < 70 ml/min/1,73 m2 at diagnosis
5)Any previous chemotherapy
6)Double cancer
7)Recurrent disease
8)Female under pregnancy
9)Patient unable to undergo chemotherapy
10)Patient unable to the protocol for any reason
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Eiso |
| Middle name | |
| Last name | Hiyama |
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
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
082-257-5951
Homepage URL
http://home.hiroshima-u.ac.jp/eiso/index.html
jplt@hiroshima-u.ac.jp
Sponsor or person
Institute
Japan Children's Cancer Group (JCCG)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Certified Review Board
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
Tel
082-257-1551
iryo-seisaku@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37施設
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
http://home.hiroshima-u.ac.jp/eiso/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
36
Results
Until December 31, 2018, 36 cases were enrolled.
Results date posted
| 2022 | Year | 04 | Month | 13 | Day |
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 | 01 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study was moved to Certified Clinical trial at 2019.
Management information
Registered date
| 2012 | Year | 10 | Month | 05 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010114
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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