Unique ID issued by UMIN | UMIN000014678 |
---|---|
Receipt number | R000017063 |
Scientific Title | Temozolomide plus bevacizumab for newly-diagnosed glioblastoma in the elderly over 75 |
Date of disclosure of the study information | 2014/08/01 |
Last modified on | 2015/05/31 18:54:06 |
Temozolomide plus bevacizumab for newly-diagnosed glioblastoma in the elderly over 75
TMZ-BEV over 75
Temozolomide plus bevacizumab for newly-diagnosed glioblastoma in the elderly over 75
TMZ-BEV over 75
Japan |
glioblastoma, high-grade glioma
Neurosurgery |
Malignancy
NO
To explore the safety and efficacy of combination therapy with temozolomide and bevacizumab for elderly patients over 75 with high-grade glioma.
Safety
Exploratory
Pragmatic
Phase I,II
safety
overall survival, progression-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
combination therapy with temozolomide and bevacizumab
75 | years-old | <= |
Not applicable |
Male and Female
1) Histological or imaging diagnosis of high-grade glioma
2) Age more than 75
3) PS (ECOG): 0, 1, 2. PS3 by neurological deficit caused by the brain tumor is also accepted.
4) Laboratory criteria (within 2wks before registration)
Neutro more than 1,500/mm3
Hb more than 8.0 g/dL
Plt more than 100,000/mm3
AST (GOT) less than 3 folds of upper limit
ALT (GPT) less than 3 folds of upper limit
total bilirubin less than 2.0 mg/dL
serum creatinine less than 1.5 mg/dL
1) presence of active infection that needs systemic treatment
2) history of cranial irradiation
3) hemorrhagic diathesis, coagulation disorder (anticoagulant/antiplatelet drugs are permitted)
4) serious cardiac disorder
5) history of myocardial infarction, cerebral infarction, deep vein thrombosis, or pulmonary embolism within 6 months
6) history of symptomatic intracranial hemorrhage within 6 months
7) uncured wound
8) poor control hypertension
9) serious, active peptic ulcer
10) pulmonary fibrosis or interstitial pneumonia
10
1st name | |
Middle name | |
Last name | Hikaru Sasaki |
Keio University School of Medicine
Neurosurgery
35 Shinanomachi, Shinjuku-ku, Tokyo
03-5363-3808
hsasaki@a5.keio.jp
1st name | |
Middle name | |
Last name | Yuko Tatsuno |
Keio University School of Medicine
Neurosurgery
35 Shinanomachi, Shinjuku-ku, Tokyo
03-5363-3808
tatsunoy@a6.keio.jp
Department of Neurosurgery, Keio University School of Medicine
Department of Neurosurgery, Keio University School of Medicine
Self funding
NO
慶應義塾大学病院(東京都)
藤田保健衛生大学附属病院(愛知県)
千葉県がんセンター(千葉県)
京都大学医学部附属病院(京都府)
金沢大学附属病院(石川県)
名古屋大学医学部附属病院(愛知県)
2014 | Year | 08 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2014 | Year | 05 | Month | 06 | Day |
2014 | Year | 08 | Month | 01 | Day |
2017 | Year | 12 | Month | 31 | Day |
2017 | Year | 12 | Month | 31 | Day |
2017 | Year | 12 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2014 | Year | 07 | Month | 28 | Day |
2015 | Year | 05 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017063
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |