Unique ID issued by UMIN | UMIN000016305 |
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Receipt number | R000018342 |
Scientific Title | Multicentric feasibility study for the combination of dose-dense cisplatin and surgical therapies for high-risk hepatoblastoma (JPLT3-H) |
Date of disclosure of the study information | 2015/01/25 |
Last modified on | 2022/04/13 10:46:26 |
Multicentric feasibility study for the combination of dose-dense cisplatin and surgical therapies for high-risk hepatoblastoma (JPLT3-H)
Dose-dense cisplatin therapy for high-risk hepatoblastoma
Multicentric feasibility study for the combination of dose-dense cisplatin and surgical therapies for high-risk hepatoblastoma (JPLT3-H)
Dose-dense cisplatin therapy for high-risk hepatoblastoma
Japan |
Hepatoblastoma with distant metastasis at diagnosis (high-risk hepatoblastoma)1
Gastrointestinal surgery | Pediatrics |
Malignancy
YES
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. Although surgical resection is the main strategy 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. Outcome of the patients with distant metastasis at diagnosis (high risk hepatoblastom) remain poor. In 2013, SIOPEL group (Europe) showed the efficacy of high dose cisplatin therapy for such cases. In this JPLT3 study, we are willing to conform the feasibility of this high dose-dense cisplatin therapy in high risk hepatoblastoma patient for the next- international collaboration study.
Safety
Phase I,II
Toxicities and these percentage
Remission rate at the end of therapy
Response rate of pre-operative chemotherapy
Percentage of surgical complications
Accomplishment rate
Pathohistological evaluation of preoerative chemothearapy
genetic analysis(cases with approval)
banking (cases with approval)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is considered as adjustment factor in dynamic allocation.
YES
No need to know
1
Treatment
Medicine |
According to SIOPEL4 protocol, after administration of preoperative chemotherapy consisting of 3 blocks chemotherapy of weekly cisplatin (CDDP) and doxorubicin (DOX), surgical resection is performed and then postsurgical chemotherapy is administrated. If the complete resection using liver transplantation is impossible after 3 block preoperative chemotherapy, additional chemotherapy consisting carboplatin and DOX is performed.
1 | years-old | <= |
18 | years-old | > |
Male and Female
1) Histologically confirmed newly diagnosed hepatoblastoma or Primary liver tumor with high levels of serum AFP
2) high risk hepatoblastoma: by international risk stratification
3) any PRETEXT with M1 (distant metastasis) or N2 (distant lymph-node metastasis)
4) or Serum alpha-fetoprotein (AFP) < 100 ng/ml
5) Definition of lung metastasis: one nodule is larger than 1 cm or several nodules with one lesion ( > 5mm)
6) Age <= 18 years and >=1 month
7) No previous chemotherapy, surgery, radiotherapy for this disease
8) Written informed consent and national/local ethics committee and regulatory approval
9) Ability to comply with requirements for submission of material for central review (radiology, pathology and biology)
10) No severe organ failure: the cases who will be alive for more than 3 months
1PS: Karnofsky/Lansky performance status>30
2White cell counts > 2000/micro L
3ALT <= 300IU/L and T.Bil < 2.0 mg/dl
But, the cases whose total bilirubin levels increased by physiological (constitutional or neonatal) icterus are excluded.
4Creatinine clearance by 24 hours urine or estimated GFR calculated by Schwartz formula > 70mL/min/1.73 m2
5No cardiac diseases requiring treatments
11) No active infections
12) Female patients of childbearing potential are not eligible unless a negative pregnancy text result has been obtained
13) Females of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method
Cases with one or more following factors
1) rhabdoid tumor
2) Hepatocellular carcinoma
3) Treatments was started at more than 15 days after the report of biopsy or
4) Cases who will be unable to be alive for more than 3 months
5) 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
6) Abnormal heart function (initial EF < 50% or SF < 28%)
7) Active double cancers
8) Recurrent diseases
9) Female under pregnancy
10) Patient unable to undergo chemotherapy by poor general condition, complications or abnormalities
11) Case whose approval to register this trail is refused
12) Patients unable to the protocol for any reasons
15
1st name | Eiso |
Middle name | |
Last name | Hiyama |
Hiroshima University
Natural Science Center for Basic Reseach 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
7348551
1-2-3, Kasumi, Minami-ku, Hiroshima
082-257-5951
http://home.hiroshima-u.ac.jp/eiso/index.html
jplt@hiroshima-u.ac.jp
Japanese Study Group for Pediatiric Liver Tumor (JPLT)
Grants-in-aid for Scientific Research, Ministry for Health, labour, and Welfare
Japanese Governmental office
Japan
Grants-in-aid for Scientific Research, Ministry for Education, Culture, Sports, Science and technology-JAPAN
HIROSHIMA UNIVERSITY
1-2-3, Kasumi, Minami-ku, Hiroshima, JAPAN
+81822575555
https://ethics.hiroshima-u.ac.j
NO
広島大学病院(広島県)他20施設
2015 | Year | 01 | Month | 25 | Day |
http://home.hiroshima-u.ac.jp/eiso/
Published
https://home.hiroshima-u.ac.jp/eiso/
15
Until September 30, 2018, 15 cases were enrolled.
2022 | Year | 04 | Month | 13 | Day |
2021 | Year | 10 | Month | 04 | Day |
Patients with primary histologically confirmed hepatoblastoma occurring at age 1 month or older and aged 18 years or younger who are at high risk according to the following international common classification
PRETEXT additional factors
M1
N2
Serum alpha-fetoprotein (hereafter serum AFP) <100 ng/ml
Central review of pathology slides by biopsy and central diagnosis of radiological images as a principle in all cases.
Participation after diagnosis of high-risk hepatoblastoma.
Anticipated Adverse Events from Chemotherapy
Myelosuppression such as acute renal failure, pancytopenia, shock, anaphylactoid symptoms, hearing loss/deafness, tinnitus, congestive papilla, retrocortical optic neuritis, blind cortex, cerebral infarction, transient ischemic attack, hemolytic uremic syndrome, myocardial infarction, angina pectoris, congestive heart failure, arrhythmia, hemolytic anemia, interstitial pneumonia, syndrome of inappropriate secretion of antidiuretic hormone (SIADH), fulminant hepatitis, hepatic dysfunction, jaundice, gastrointestinal hemorrhage, gastrointestinal ulcer, gastrointestinal perforation, acute pancreatitis, hyperglycemia, aggravation of diabetes mellitus, rhabdomyolysis, leukoencephalopathy,
Alopecia, nausea/vomiting, ileus, diarrhea, stomatitis, liver dysfunction, electrolyte abnormalities, peripheral neuropathy, convulsion, consciousness disorder, myocardial disorder, heart failure, electrocardiogram abnormalities, palpitations, tachycardia, chest pain, proteinuria, pigmentation, headache, reverse smoking, hypotension, hyperuricemia, dehydration, Raynaud's-like symptoms
Anticipated Adverse Events from Surgical Resection
Dysfunction of surgical site, bleeding, organ injury, combined resection, hypotension, hypertension, ventilatory disturbance, apnea, malignant hyperthermia, hypothermia, atelectasis, vomiting/aspiration, excessive transfusion, undertransfusion, wound infection, ileus, postoperative bleeding, gastrointestinal fistula, gastrointestinal perforation, hematoma, pain, hydronephros/hydroureter, and nonfunctioning kidney
Primary Endpoint: Protocol Completion Rate
Secondary endpoint :
End-of-treatment remission rate
Treatment response to neoadjuvant chemotherapy
Rate of complete resections
Surgical complication rate
Histopathological evaluation after neoadjuvant chemotherapy
Completed
2014 | Year | 12 | Month | 15 | Day |
2019 | Year | 01 | Month | 30 | Day |
2015 | Year | 01 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2015 | Year | 01 | Month | 22 | Day |
2022 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018342
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