Unique ID issued by UMIN | UMIN000000546 |
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Receipt number | R000000663 |
Scientific Title | Phase II study of combination chemotherapy and high-dose chemotherapy in treating young children with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumors |
Date of disclosure of the study information | 2006/12/08 |
Last modified on | 2014/07/06 15:41:48 |
Phase II study of combination chemotherapy and high-dose chemotherapy in treating young children with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumors
Combination chemotherapy in treating young children with medulloblastoma/sPNET
Phase II study of combination chemotherapy and high-dose chemotherapy in treating young children with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumors
Combination chemotherapy in treating young children with medulloblastoma/sPNET
Japan |
medulloblastoma or supratentorial primitive neuroectodermal tumors
Pediatrics |
Malignancy
NO
Determine whether combination chemotherapy and high-dose chemotherapy achieves more than 50% of 3-year progression-free survival for young children with medulloblastoma/sPNET.
Efficacy
Confirmatory
Phase II
3-year progressin-free survival
3-year overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Patients recieve chemotherapy consisting of cyclophosphamide, etoposide, cisplatin and vincristine.
Chemotherapy repeats every 4 weeks for 4 courses. Five weeks after the chemotherapy, patients recieve 2 courses of high-dose chemotherapy (HDC) with stem cell rescue. HDC-CCE consists of cyclophosphamide, etoposide, and cisplatin. HDC-TM consists of thiotepa and melphalan.
Radiotherapy is not performed except progressive or refractory disease.
0 | years-old | <= |
3 | years-old | > |
Male and Female
Diagnosis of 1 of the following, medulloblastoma, supratentorial primitive neuroectodermal tumors, ependymoblastoma, pineoblastoma, CNS neuroblastoma, medullomyoblastoma.
Has undergone definitive surgery within the past 42 days.
No prior radiation therapy or chemotherapy.
PS score: 0-3.
WBC >2000, ANC >1000,
Platelet count >100000,
ALT <100 IU/ml,
Billirubin <1.5 mg/dl,
Serum creatinine < upper limit of normal,
Normal electorocardiogram.
Has double cancer.
Has cardiac disease for which treatment is necessary.
40
1st name | |
Middle name | |
Last name | Junichi Hara |
Osaka City General Hospital
Pediatric Hematology/Oncology
2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka, Japan
1st name | |
Middle name | |
Last name | Keiko Okada |
Osaka City General Hospital
Pediatric Hematology/Oncology
2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka, Japan
Japanese Pediatric Brain Tumor Consortium
Osaka City
Non profit foundation
NO
2006 | Year | 12 | Month | 08 | Day |
Unpublished
No longer recruiting
2006 | Year | 03 | Month | 21 | Day |
2006 | Year | 12 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2006 | Year | 12 | Month | 08 | Day |
2014 | Year | 07 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000663
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