Unique ID issued by UMIN | UMIN000001116 |
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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 |
JPLT2 protocol (CITA and ITEC regimen)for the pediatric liver tumor in Japan
JPLT(Japanese Study Group for Pediatric Liver Tumor)-2 protocol
JPLT2 protocol (CITA and ITEC regimen)for the pediatric liver tumor in Japan
JPLT(Japanese Study Group for Pediatric Liver Tumor)-2 protocol
Japan |
hepatoblastoma
hepatocellular carcinoma
Hepato-biliary-pancreatic surgery | Pediatrics |
Malignancy
NO
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.
Safety,Efficacy
Phase II
Effect of tumor reduction
Improvement of event-free and overall survivals
Safety
Pancytopenia
Digestive organ dysfunction
Late complications (cardiac dysfunction, growth disorder, hearing disorder)
Observational
1 | days-old | <= |
15 | years-old | > |
Male and Female
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.
Note that, even if an intrahepatic tumor, the benign liver tumor, hepatocellular carcinoma, and metastatic liver tumors should be excluded.
220
1st name | Hiyama |
Middle name | |
Last name | Eiso |
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
082-257-5216
http://home.hiroshima-u.ac.jp/jpltstudy/index.html
kogura@hiroshima-u.ac.jp
Japanese Study Group for Pediatric Liver Tumors
Foundation from Children's cancer assotiation of Japan.
Mitsui Life Social Walfare Foundation.
Non profit foundation
Japan
Children's Cancer Association of Japan
Ethical Committee for Clinical Research of Hiroshima University
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
082-257-5907
gakujutu-kikaku@office.hiroshima-u.ac.jp
NO
広島大学病院(広島県)他117施設
2008 | Year | 04 | Month | 09 | Day |
http://home.hiroshima-u.ac.jp/jpltstudy/index.html
Published
http://home.hiroshima-u.ac.jp/eiso/
404
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.
2021 | Year | 09 | Month | 27 | Day |
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.
The patient is enrolled from the institutions registered in JPLT (the Japanese Study Group for Pediatric Liver Tumor).
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
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
Completed
2006 | Year | 04 | Month | 01 | Day |
2000 | Year | 03 | Month | 01 | Day |
2000 | Year | 04 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2017 | Year | 03 | Month | 01 | Day |
2018 | Year | 03 | Month | 01 | Day |
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.
2008 | Year | 04 | Month | 09 | Day |
2021 | Year | 09 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001351
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