May. 28, 2020 |
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April. 11, 2024 |
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jRCTs051200021 |
Phase II study to evaluate the efficacy and safety of the introduction of high-dose chemotherapy comprising thiotepa and melphalan to conventional chemoradiotherapy depending on new risk classification for medulloblastoma (JCCG MB19) |
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Phase II study of new risk classification and high-dose chemotherapy for medulloblastoma (JCCG MB19) |
Hara Junichi |
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Department of Pediatric Hematology and Oncology, Osaka City General Hospital |
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2-13-22, Miyakozimahondori, Miyakozima-ku, Osaka |
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+81-6-6929-1221 |
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j-hara@med.osakacity-hp.or.jp |
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Yamasaki Kai |
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Department of Pediatric Hematology and Oncology, Osaka City General Hospital |
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2-13-22, Miyakozimahondori, Miyakozima-ku, Osaka |
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+81-6-6929-1221 |
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ka-yamasaki@med.osakacity-hp.or.jp |
Recruiting |
May. 28, 2020 |
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June. 15, 2020 | ||
229 | ||
Interventional |
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single arm study |
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open(masking not used) |
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historical control |
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parallel assignment |
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treatment purpose |
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1) Locally diagnosed as medulloblastoma after tumor resection or biopsy |
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1) Active double cancer (synchronous double cancer and metachronous double cancer with disease-free period of 5 years or less). |
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0age 0month over | ||
30age old not | ||
Both |
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Medulloblastoma |
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With the introduction of new risk classification that combines the molecular classification and the conventional risk factor (M stage), three risk groups for ages 4 and older (low risk (LR), standard risk (SR) and high risk (HR)) and two risk groups for age less than 4 years (standard risk (SR) and high risk (HR)) are defined. |
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Medulloblastoma |
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high dose chemotherapy, thiotepa, double conditioning, molecular classification |
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D008527 |
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D017427 |
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Age greater than or equal to 4 years without metastases: 5yr progression-free survival |
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3yr and 5 yr overall survival |
Japan Agency for Medical Research and Development | |
Applicable |
Osaka Metropolitan University Hospital Certified Review Board | |
1-27 Abeno-Medics Asahi-machi Abeno-ku Osaka City, Osa ka, Osaka | |
+81-6-6645-3456 |
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gr-a-knky-crb@omu.ac.jp | |
Approval | |
April. 09, 2020 |
No |
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なし | |
none |