Unique ID issued by UMIN | UMIN000015566 |
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Receipt number | R000018089 |
Scientific Title | Phase I study of neo-adjuvant chemoradiation therapy for newly diagnosed malignant astrocytomas |
Date of disclosure of the study information | 2014/11/01 |
Last modified on | 2020/05/03 10:49:47 |
Phase I study of neo-adjuvant chemoradiation therapy for newly diagnosed malignant astrocytomas
neoadjuvant chemoradiation for malignant astrocytomas
Phase I study of neo-adjuvant chemoradiation therapy for newly diagnosed malignant astrocytomas
neoadjuvant chemoradiation for malignant astrocytomas
Japan |
malignant astyrocytomas
Neurosurgery |
Malignancy
NO
To determine the safety and efficacy of neo-adjuvant cheomoradiation therapy for newly diagnosed malignant astrocytomas
Safety,Efficacy
Confirmatory
Explanatory
Phase I
Occurrence of adverse events until 12 weeks after treatment
progression-free survival, overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Device,equipment | Maneuver |
day 1-30 Temozolomide 75mg/m2, once daily
day 15-30 IMRT 6.0Gy x 12 fractions
day 37 surgical removal
18 | years-old | <= |
Not applicable |
Male and Female
clinically diagnosed malignant astrocytomas
no evidence of CSF dissemination
visible on MRI
normal bone marrow, liver, and renal function
written informed consent
large tumor (>6cm)
sign of tent-herniation
existence of extracranial malignant tumor
pregnancy
psychological disorder
HIV positive patients
history of pneumonitis
history of radiation therapy for intracranial lesions
20
1st name | Toshihiko |
Middle name | |
Last name | Iuchi |
Chiba Cancer Center
Division of Neurological Surgery
2608717
666-2 Nitona-cho, Chuo-ku, Chiba, Japan
043-264-5431
tiuchi@chiba-cc.jp
1st name | Toshihiko |
Middle name | |
Last name | Iuchi |
Chiba Cancer Center
Division of Neurological Surgery
260-8717
666-2 Nitona-cho, Chuo-ku, Chiba, Japan
043-264-5431
tiuchi@chiba-cc.jp
Chiba Cancer Center
Chiba Cancer Center
Local Government
Ethics Review Board, Chiba Cancer Center
666 2 Nitonacho, Chuoku, Chiba, Japan
043-264-5431
"k.mzn20@pref.chiba.lg.jp" <k.mzn20@pref.chiba.lg.jp>
NO
千葉県がんセンター(千葉県)
Chiba Cancer Center (Chiba)
2014 | Year | 11 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 05 | Month | 06 | Day |
2014 | Year | 03 | Month | 25 | Day |
2014 | Year | 11 | Month | 01 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2014 | Year | 10 | Month | 30 | Day |
2020 | Year | 05 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018089
Research Plan | |
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Registered date | File name |
2018/04/09 | 試験計画書v02.doc |
Research case data specifications | |
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Research case data | |
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