Unique ID issued by UMIN | UMIN000000545 |
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Receipt number | R000000661 |
Scientific Title | Phase II study of reduced-dose craniospinal irradiation and combination chemotherapy in treating pediatric patients with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumors |
Date of disclosure of the study information | 2006/12/08 |
Last modified on | 2015/09/10 12:13:51 |
Phase II study of reduced-dose craniospinal irradiation and combination chemotherapy in treating pediatric patients with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumors
Reduced-dose radiation plus chemotherapy in treating pediatric patients with medulloblastoma/sPNET
Phase II study of reduced-dose craniospinal irradiation and combination chemotherapy in treating pediatric patients with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumors
Reduced-dose radiation plus chemotherapy in treating pediatric patients with medulloblastoma/sPNET
Japan |
medulloblastoma or supratentorial primitive neuroectodermal tumors
Pediatrics |
Malignancy
NO
Determine whether multi-drug combination chemotherapy reduces craniospinal irradiation.
Efficacy
Confirmatory
Phase II
3-year progression-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. Radiotherapy was started concomitantly with the second course of chemotherapy. Radiation doses were 50 Gy to the primary site and 18 Gy to the craniospinal axis.
<Standard-risk medulloblastoma>
Chemotherapy repeats every 4 weeks for 5 courses.
<High-risk medulloblastoma and sPNET>
Chemotherapy repeats every 4 weeks for 4 courses. Five weeks after the chemotherapy, patients recieve high-dose chemotherapy consisting of thiotepa and melphalan with stem cell rescue.
3 | years-old | <= |
18 | 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.
100
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 |
2015 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000661
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