JPLT3-S JPLT3-I

JRCT ID: jRCTs061180086

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: hepatoblastoma
• Date of first enrollment: 11/09/2012
• Target sample size: 78
• Study type: Interventional
• Intervention(s): At diagnosis, hepatoblastoma without distant metastasis was classified into standard and intermediate risks by imaging diagnosis, and the validation of cisplatin monotherapy for standard risk and that of PLADO therapy for intermediate risk group will be estimated.

Outcome(s)

• Primary Outcome: 3-year progression free survival

Secondary Outcome

Protocol completion rate of cisplatin monotherapy (standard risk)
Effectiveness of preoperative chemotherapy
Correlation between selection of therapy based on effectiveness of chemotherapy during preoperative chemotherapy and prognosis (intermediate risk)
Complete resection rate
Surgical complication rate
Overall survival (OS)
Grade toxicity by CTCAE v 4.0
Evaluation of biological, diagnostic and pathological forms of hepatoblastoma for future risk assessment
Identification of clinicopathological risk factor (undifferentiated small cell type, AFP value, age of onset, etc.)
Identification of molecular biological risk factors (beta catenin abnormality, telomerase activation, etc.)
Gene analysis (cases where consent was obtained only)

Key inclusion & exclusion criteria

• Age minimum: >= 1month old
• Age maximum: <= 18age old
• Gender: Both

Include criteria

Of those cases who showed serum AFP is abnormally elevated and was diagnosed as childhood liver cancer, those classified as standard and intermediate risk by under the common international classification are targeted.
- High risk = one of the following patients (not subject to this clinical trial) The PRETEXT appendix factor is M1 N2 positive. Serum alpha-fetoprotein (h serum AFP) < 100 ng / ml.
- Intermediate risk = one of the following patients (however, M1, N2, serum AFP <100 ng / ml automatically becomes high risk, so it is not subject to this clinical trial)
PRETEXT IV
The PRETEXT appendant factors are E1, E1a, E2, E2a, H1, N1, P2, P2a, V3, V3a
Multiple (tumor exists in the liver in two or more lesions)
Diagnosis at age 3 years and older
Example of liver rupture at first visit
- Standard risk = All patients except the above

Exclude criteria

1) High risk = one of the following patients
Serum AFP <100 ng / ml
PRETEXT appendix factor
M1 (regardless of metastatic organ)
N2 (distant lymph node metastasis)
2) hepatocellular carcinoma
3) When treatment is started after 15 days or more have passed since biopsy or diagnostic report was made
4) Cases not considered to be viable for more than 3 months
5) Renal function abnormality (GFR is normal 50% or less or 2 years old or more, 70 mL / min / 1.73 m 2 or less)
6) Double cancer of activity
7) Recurrence example
8) Pregnant women / Possible pregnant women / Lactating women
9) In cases where the general condition is extremely bad or those determined to be unable to tolerate chemotherapy due to complications / complications / malformations
10) Impossible to follow the protocol for some reason

Related Information

• Primary Sponsor: Hiyama Eiso
• Secondary ID(s): UMIN 000009049,UMIN000009050