Unique ID issued by UMIN | UMIN000019160 |
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Receipt number | R000022155 |
Scientific Title | A study of the impact of Gliadel for initial and recurrent malignant glioma on the nerve fibers Phase 2 study |
Date of disclosure of the study information | 2015/10/01 |
Last modified on | 2016/05/11 09:38:12 |
A study of the impact of Gliadel for initial and recurrent malignant glioma on the nerve fibers
Phase 2 study
A study of impact of Gliadel on the nerve fibers
A study of the impact of Gliadel for initial and recurrent malignant glioma on the nerve fibers
Phase 2 study
A study of impact of Gliadel on the nerve fibers
Japan |
Initial and recurrent malignant glioma
Neurosurgery |
Malignancy
NO
Measurement the distance between Gliadel placement surface and the nerve fibers, to assess neurological function as an index for the effect on motor function
Safety
Measurement of three-dimensional distance from the cutting surface to the corticospinal tract.
Motor function evaluation of the upper and lower extremities, next day, 4weeks and 12 weeks after operation by Manual Muscle Testing.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Gliadel implantation
Primary malignant glioma
Chemoradiation therapy (Radiation temodal)
Chemotherapy (temodal)
Recurrent malignant glioma
Chemotherapy (temodal)
15 | years-old | <= |
75 | years-old | >= |
Male and Female
There is a suspicion of a malignant glioma in the brain parenchyma
It thought possible corticospinal truct sparing
Patient it is determined that there is likely to die within 6 months
Patients who have a history or complications of malignant tumors other than brain
Patient pregnancy, is a breast-feeding women
20
1st name | |
Middle name | |
Last name | Kyousuke Kamada |
Asahikawa Medical Univesity
Neurosurgery
2-1,Midorigaoka-Higashi,Asahikawa,Hokkaidou,Japan
0166-65-2111
kamady-k@umin.ac.jp
1st name | |
Middle name | |
Last name | Ryogo Anei |
Asahikawa Medical University
Neurosurgery
2-1,Midorigaoka-Higashi,Asahikawa,Hokkaidou,Japan
0166-65-2111
ryogoanei@gmail.com
Asahikawa Medical University
Eisai, Co., Ltd
Profit organization
NO
2015 | Year | 10 | Month | 01 | Day |
Unpublished
Open public recruiting
2015 | Year | 08 | Month | 01 | Day |
2015 | Year | 10 | Month | 01 | Day |
Detailed follow-up in the normal practice
2015 | Year | 09 | Month | 30 | Day |
2016 | Year | 05 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022155
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