Unique ID issued by UMIN | UMIN000009049 |
---|---|
Receipt number | R000010106 |
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 09:12:07 |
Risk stratified, multicentrial Phase II trials for hepatoblastoma without distant metastasis at diagnosis
JPLT3-S protocol
Risk stratified, multicentrial Phase II trials for hepatoblastoma without distant metastasis at diagnosis
JPLT3-S protocol
Japan |
hepatoblastoma
Hepato-biliary-pancreatic surgery | Pediatrics |
Malignancy
NO
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.
Safety,Efficacy
Phase II
3-year progression free survival: 3-year PFS
Outworking rate of cis-platin
(CDDP) monotherapeutic regimen
Response rate to neo-adjuvant chemotherapy
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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
4 cycles with neo-adjuvant cisplatin, monotherapy which is administered for 24 hours with 2 weeks duration. However, 2.7 and 1.8 mg/kg of cisplatin is administered in the infants whose body weight is 5-10 and < 5kg, respectively.
After these 4 cycles, surgical resection is performed and 2 cycles of adjuvant chemotherapy.
1 | days-old | <= |
18 | years-old | >= |
Male and Female
1) Histologically confirmed newly diagnosed hepatoblastoma or Primary liver tumor with high levels of serum AFP
Standard risk hepatoblastoma: by international risk stratification
PRETEXT I, II or III
Serum alpha-fetoprotein (AFP) > 100 micro-g/L
No additional PRETEXT criteria
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
Cases with one of the following factors
1)High and Intermediate risk hepatoblastoma: Serum alpha-fetoprotein (AFP) <=100 micro-g/L
Tumor involving all 4 hepatic sections - PRETEXT IV
Additional PRETEXT criteria
Extrahepatic abdominal disease (E1, E1a, E2, E2a)
Intraperitoneal hemorrhage or tumor rupture (H1)
Distant metastases, any site (M1)
Lymph node metastases (N1, N2)
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
100
1st name | Eiso |
Middle name | |
Last name | Hiyama |
Hiroshima University
Natural Science Center For Basic Research and Development
734-8551
1-2-3, Kasumi, Minami-ku, Hiroshima
082-257-5951
eiso@hiroshima-u.ac.jp
1st name | Sho |
Middle name | |
Last name | Kurihara |
Hiroshima University Hospital
Pediatric Surgery
734-8551
1-2-3, Kasumi, Minami-ku, Hiroshima
082-257-5951
http://home.hiroshima-u.ac.jp/eiso/index.html
jplt@hiroshima-u.ac.jp
Japan Children's Cancer Group (JCCG)
AMED(Japan Agency for Medical Research and Development
Japanese Governmental office
Japan
Hiroshima University Certified Review Board
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.jp
NO
広島大学 他 37施設
2012 | Year | 10 | Month | 05 | Day |
http://home.hiroshima-u.ac.jp/eiso/
Unpublished
79
Until September 30, 2018, 79 cases were enrolled.
2021 | Year | 09 | Month | 27 | Day |
Completed
2013 | Year | 01 | Month | 25 | Day |
2019 | Year | 02 | Month | 08 | Day |
2013 | Year | 04 | Month | 01 | Day |
2021 | Year | 10 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
This study was moved to Certified Clinical Trial at 2019.
2012 | Year | 10 | Month | 05 | Day |
2022 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010106
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |